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    Coronavirus

    This report considers only clinical trials that are associated with COVID-19 vaccines.

    Developed by Shray Alag, The Harker School
    Sections: Correlations, Clinical Trials, and HPO

    Correlations computed by analyzing all clinical trials.

    Navigate: Clinical Trials and HPO


    Correlated Drug Terms (26)


    Name (Synonyms) Correlation
    drug2930 SARS-CoV-2 rS/Matrix-M1 Adjuvant Wiki 0.45
    drug2490 Placebo Wiki 0.37
    drug3923 mRNA-1273 Wiki 0.37
    Name (Synonyms) Correlation
    drug241 Anti-SARS-CoV-2 equine immunoglobulin fragments (INOSARS) Wiki 0.32
    drug454 Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) placebo group Wiki 0.32
    drug581 COVI-VAC Wiki 0.32
    drug457 Biological: mRNA-1273: 50 mcg Wiki 0.32
    drug739 ChAdOx1 nCoV-19 single dose + paracetamol Wiki 0.32
    drug1325 Flu shot Wiki 0.32
    drug2002 MenACWY single dose + paracetamol Wiki 0.32
    drug386 BNT162b3 Wiki 0.32
    drug740 ChAdOx1 nCoV-19 two dose + paracetamol Wiki 0.32
    drug452 Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cell) low-dose group Wiki 0.32
    drug453 Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) high-dose group Wiki 0.32
    drug1921 MMR vaccine Wiki 0.32
    drug456 Biological: mRNA-1273: 100 mcg Wiki 0.32
    drug1818 Licensed seasonal influenza vaccine Wiki 0.32
    drug2570 Placebo/Aluminum Adjuvant of Inactivated SARS-CoV-2 vaccine Wiki 0.32
    drug2001 MenACWY prime & saline placebo boost + paracetamol Wiki 0.32
    drug2924 SARS-CoV-2 rS/Matrix M1-Adjuvant Wiki 0.32
    drug1643 Inactivated SARS-CoV-2 vaccine (Vero cell) Wiki 0.32
    drug2529 Placebo Vaccine Wiki 0.22
    drug1642 Inactivated SARS-CoV-2 Vaccine (Vero cell) Wiki 0.18
    drug384 BNT162b1 Wiki 0.18
    drug366 BCG Vaccine Wiki 0.16
    drug385 BNT162b2 Wiki 0.16

    Correlated MeSH Terms (6)


    Name (Synonyms) Correlation
    D018746 Systemic Inflammatory Response Syndrome NIH 0.32
    D014115 Toxemia NIH 0.32
    D018805 Sepsis NIH 0.32
    Name (Synonyms) Correlation
    D018352 Coronavirus Infections NIH 0.25
    D045169 Severe Acute Respiratory Syndrome NIH 0.19
    D014777 Virus Diseases NIH 0.13

    Correlated HPO Terms (1)


    Name (Synonyms) Correlation
    HP:0100806 Sepsis HPO 0.32

    Clinical Trials

    Navigate: Correlations   HPO

    There are 10 clinical trials


    1 Multicenter, Randomized, Double Blind, Parallel Placebo Controlled, Phase III Clinical Trial to Evaluate the Protective Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) in Healthy Population Aged 18 Years Old and Above

    This is a multicenter, randomized, double blind, parallel placebo controlled, phase 3 clinical trial to evaluate the protective efficacy, safety and immunogenicity of inactivated SARS-CoV-2 vaccines in healthy population 18 years old and above.

    NCT04510207
    Conditions
    1. COVID-19
    Interventions
    1. Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell)
    2. Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell)
    3. Biological: Placebo

    Primary Outcomes

    Measure: The incidence of COVID-19 cases after two-doses of vaccination

    Time: From14 days after the second dose to 6 month after the second dose

    Secondary Outcomes

    Measure: The incidence of severe cases of SARS-CoV-2 pneumonia and deaths accompanied by COVID-19 after two-doses of vaccination

    Time: From14 day after the second dose to 6 month after the second dose

    Measure: The incidence of any adverse reactions/events

    Time: 28 days after each immunization

    Measure: The incidence of serious adverse events (SAE)

    Time: From the beginning of the first dose to 12 months after the second immunization

    Measure: The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody

    Time: 14 days after full course of immunization

    Measure: The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody

    Time: 14 days after full course of immunization

    Measure: The Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody

    Time: 14 days after full course of immunization

    Measure: The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody

    Time: 28 days, 3rd month, 6th month, 9th month, and 12th month after 2 doses of immunization

    Measure: The 4-fold increase rate of anti-SARS-CoV-2 neutralizing antibody

    Time: 28 days, 3rd month, 6th month, 9th month, and 12th month after 2 doses of immunization

    Measure: The Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody

    Time: 28 days, 3rd month, 6th month, 9th month, and 12th month after 2 doses of immunization

    Other Outcomes

    Measure: the anti-SARS-CoV-2 neutralizing antibody protective level against COVID-19

    Time: 14 days after 2 doses of vaccination

    Measure: The occurrence of ADE

    Time: From the beginning of the first dose to 12 months after the second immunization
    2 A Multi-site, Phase I/II, 2-Part, Dose-Escalation Trial Investigating the Safety and Immunogenicity of a Prophylactic SARS-CoV-2 RNA Vaccine (BNT162b3) Against COVID-19 Using Different Dosing Regimens in Healthy Adults

    This trial has two parts. Part A, a dose finding part, with three dose escalation cohorts, one dose de-escalation cohort, three dose refinement cohorts, and up to three optional cohorts in older subjects. Part B, a part with expansion cohorts with dose levels which are selected using data generated in Part A. The vaccine BNT162b3 will be administered using a Prime/Boost (P/B) regimen.

    NCT04537949
    Conditions
    1. Covid-19
    2. Protection Against COVID-19
    Interventions
    1. Biological: BNT162b3

    Primary Outcomes

    Measure: Solicited local reactions at the injection site (pain/tenderness, erythema/redness, induration/swelling) recorded up to 7±1 days after each immunization.

    Time: up to 7 days following each dose administration

    Measure: Solicited systemic reactions (nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever) recorded up to 7±1 days after each immunization.

    Time: up to 7 days following each dose administration

    Measure: The proportion of subjects with at least 1 unsolicited treatment emergent adverse event (TEAE) occurring up to 21±2 days after the prime immunization.

    Time: 21 days following dose administration

    Measure: The proportion of subjects with at least 1 unsolicited TEAE occurring up to 28±4 days after the boost immunization.

    Time: 28 days following dose administration

    Secondary Outcomes

    Description: At 7±1 days and 21±2 days after primary immunization and at 21±2 days, 28±4 days, 63±5 days, 162±7 days, and 365±14 days after the boost immunization.

    Measure: Functional antibody responses.

    Time: up to 365 days following dose administration

    Description: At 7±1 days and 21±2 days after primary immunization and at 21±2 days, 28±4 days, 63±5 days, 162±7 days, and 365±14 days after the boost immunization.

    Measure: Fold increase in functional antibody titers.

    Time: up to 365 days following dose administration

    Description: At 7±1 days and 21±2 days after primary immunization and at 21±2 days, 28±4 days, 63±5 days, 162±7 days, and 365±14 days after the boost immunization.

    Measure: Number of subjects with seroconversion defined as a minimum of 4-fold increase of functional antibody titers as compared to baseline.

    Time: up to 365 days following dose administration
    3 A Phase 3, Randomised, Observer-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) With Matrix-M1™ Adjuvant in Adult Participants 18-84 Years of Age in the United Kingdom

    This is a study to evaluate the efficacy, immune response, and safety of a coronavirus disease 2019 (COVID-19) vaccine called SARS-CoV-2 rS with Matrix-M1 adjuvant in adults aged 18-84 years in the United Kingdom. A vaccine causes the body to have an immune response that may help prevent the infection or reduce the severity of symptoms. An adjuvant is something that can make a vaccine work better. This study will look at the protective effect, body's immune response, and safety of SARS-CoV-2 rS with Matrix-M1 adjuvant in the study population. Participants in the study will randomly be assigned to receive SARS-CoV-2 rS with Matrix-M1 adjuvant or placebo. Each participant in the study will receive a total of 2 intramuscular injections over the course of the study. Approximately 15,000 participants will take part in the study. The first 400 participants who meet additional criteria will receive a flu vaccine, in addition to the SARS-CoV-2 rS vaccine or placebo, as part of a sub-study. An effort will be made to enroll a target of at least 25% of participants who are ≥ 65 years of age, as well as prioritizing other groups that are most affected by COVID-19, including racial and ethnic minorities.

    NCT04583995
    Conditions
    1. SARS-CoV-2 Infection
    2. COVID-19
    Interventions
    1. Biological: SARS-CoV-2 rS/Matrix M1-Adjuvant
    2. Other: Placebo
    3. Biological: Licensed seasonal influenza vaccine

    Primary Outcomes

    Description: Number of participants, testing serologically negative for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at baseline, with first occurrence of positive (+) polymerase chain reaction (PCR)-confirmed SARS-CoV-2 illness with symptomatic mild, moderate, or severe COVID-19 with onset from Day 28 through the length of the study.

    Measure: Participants with Symptomatic Mild, Moderate, or Severe Coronavirus Disease 2019 (COVID-19)

    Time: From Day 28 to Day 386

    Secondary Outcomes

    Description: Number of participants, testing serologically negative for SARS-CoV-2 at baseline with first occurrence of (+) PCR-confirmed, SARS-CoV-2 illness with symptomatic moderate or severe COVID-19 with onset from Day 28 through the length of the study.

    Measure: Participants with Symptomatic Moderate or Severe COVID-19

    Time: From Day 28 to Day 386

    Description: Number of participants, regardless of serostatus at baseline, with first occurrence of (+) PCR-confirmed, SARS-CoV-2 illness with symptomatic mild, moderate, or severe COVID-19 assessed from Day 28 through the length of the study.

    Measure: Participants with Symptomatic Mild, Moderate, or Severe COVID-19 Regardless of Baseline Serostatus

    Time: From Day 28 to Day 386

    Description: Number of participants, regardless of serostatus at baseline, with first occurrence of (+) PCR-confirmed, or nucleocapsid protein serologically confirmed, SARS-CoV-2 illness with asymptomatic or symptomatic COVID-19 with onset from Day 28 through the length of the study.

    Measure: Participants with Asymptomatic or Symptomatic COVID-19

    Time: From Day 28 to Day 386

    Description: Number of participants, regardless of serostatus at baseline, with first occurrence of (+) PCR-confirmed, SARS-CoV-2 illness with COVID-19 with onset from Day 28 through the length of the study.

    Measure: Participants with COVID-19 requiring Hospitalization, Intensive Care Unit (ICU), or Mechanical Ventilation

    Time: From Day 28 to Day 386

    Description: Number of participants, regardless of serostatus at baseline, with first occurrence of (+) PCR-confirmed, SARS-CoV-2 illness with symptomatic mild COVID-19 (with no progression to moderate or severe COVID-19 during the course of the COVID-19 episode) with onset from Day 28 through the length of the study.

    Measure: Participants with Symptomatic Mild COVID-19

    Time: From Day 28 to Day 386

    Description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by enzyme-linked immunosorbent assay (ELISA) expressed as GMEUs at Day 0 and Day 35.

    Measure: Serum IgG Antibody Levels at Multiple Time Points Expressed as Geometric Mean ELISA Units (GMEUs)

    Time: Day 0 to Day 35

    Description: Number of participants with SAEs through the length of the study by Medical Dictionary for Regulatory Activities (MedDRA) classification and relationship to study vaccination.

    Measure: Participants with Serious Adverse Events (SAEs)

    Time: 386 days

    Description: Number of participants with MAAEs related to study vaccination through the length of the study by MedDRA classification.

    Measure: Participants with Medically Attended Adverse Events (MAAEs) Related to Study Vaccination

    Time: 386 days

    Description: Number of participants with AESIs, which include potential immune-mediated medical conditions (PIMMCs) and AESIs relevant to COVID-19 such as possible vaccine-enhanced disease by MedDRA classification through the length of the study.

    Measure: Participants with Adverse Events of Special Interest (AESIs)

    Time: 386 days

    Description: Number of participants with solicited local and systemic AEs for 7 days after each study vaccination.

    Measure: Participants with Solicited Local and Systemic Adverse Events (AEs)

    Time: 28 days

    Description: Number of participants with all MAAEs through Day 35 by MedDRA classification and relationship to study vaccination.

    Measure: Participants with All MAAEs Through Day 35

    Time: 35 days

    Description: Number of participants with unsolicited AEs through Day 49 by MedDRA classification and relationship to study vaccination.

    Measure: Participants with Unsolicited AEs Through Day 49

    Time: 49 days
    4 Bacillus Calmette-Guerin Vaccination as Defense Against SARS-CoV-2: A Randomized Controlled Trial to Protect Health Care Workers by Enhanced Trained Immune Responses

    SARS-CoV-2 spreads rapidly throughout the world. A large epidemic would seriously challenge the available hospital capacity, and this would be augmented by infection of healthcare workers (HCW). Strategies to prevent infection and disease severity of HCW are, therefore, desperately needed to safeguard continuous patient care. Bacille Calmette-Guérin (BCG) is a vaccine against tuberculosis, with protective non-specific effects against other respiratory tract infections in in vitro and in vivo studies, and reported morbidity and mortality reductions as high as 70%. Furthermore, in our preliminary analysis, areas with existing BCG vaccination programs appear to have lower incidence and mortality from COVID191. The investigators hypothesize that BCG vaccination can reduce HCW infection and disease severity during the epidemic phase of SARS-CoV-2.

    NCT04348370
    Conditions
    1. Coronavirus
    2. Coronavirus Infection
    3. Coronavirus as the Cause of Diseases Classified Elsewhere
    Interventions
    1. Biological: BCG Vaccine
    2. Biological: Placebo Vaccine
    MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

    Primary Outcomes

    Description: The primary outcome measure is the development of COVID19 infection. We will use the Cox proportional-hazards model to calculate hazard ratios for the development of Covid-19. This will be reported as the proportion of individuals receiving the intervention who are PCR-positive or seroconvert. defined as number of new cases during the 6 month time period

    Measure: Incidence of COVID 19 Infection

    Time: 6 months

    Secondary Outcomes

    Description: The secondary outcome measure is disease severity calculated using the Covid Severity Scale Scoring of 0 -10. A score of 10 is worse and a score of 0 is best. Disease severity score will be based on the level of care required for individuals who test positive for COVID19 as follows: non-hospital-based care; patient hospitalized but no oxygen required; hospitalized and oxygen required; patient treated in intensive care and/or on mechanical ventilation; patient died. Additional WHO criteria for severity include severe pneumonia, respiratory failure, acute respiratory distress syndrome, sepsis and septic shock.

    Measure: Disease Severity

    Time: up to 6 months
    5 A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS

    This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals. The study consists of 2 parts: Phase 1: to identify preferred vaccine candidate(s) and dose level(s); Phase 2/3: an expanded cohort and efficacy part. The study will evaluate the safety, tolerability, and immunogenicity of 2 different SARS CoV 2 RNA vaccine candidates against COVID 19 and the efficacy of 1 candidate: - As a 2-dose (separated by 21 days) schedule; - At various different dose levels in Phase 1; - In 3 age groups (Phase 1: 18 to 55 years of age, 65 to 85 years of age; Phase 2/3: ≥12 years of age [stratified as 12-15, 16-55 or >55 years of age]). The candidate selected for evaluation in Phase 2/3 is BNT162b2 (mid-dose). Participants ≥16 years of age who originally received placebo will be offered the opportunity to receive BNT162b2 at defined points as part of the study.

    NCT04368728
    Conditions
    1. SARS-CoV-2 Infection
    2. COVID-19
    Interventions
    1. Biological: BNT162b1
    2. Biological: BNT162b2
    3. Other: Placebo

    Primary Outcomes

    Description: Pain at the injection site, redness, and swelling as self-reported on electronic diaries.

    Measure: Percentage of participants in Phase 1 reporting local reactions

    Time: For 7 days after dose 1 and dose 2

    Description: Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.

    Measure: Percentage of participants in Phase 1 reporting systemic events

    Time: For 7 days after dose 1 and dose 2

    Description: As elicited by investigational site staff

    Measure: Percentage of participants in Phase 1 reporting adverse events

    Time: From dose 1 through 1 month after the last dose

    Description: As elicited by investigational site staff

    Measure: Percentage of participants in Phase 1 reporting serious adverse events

    Time: From dose 1 through 6 months after the last dose

    Description: As measured at the central laboratory

    Measure: Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values

    Time: 1 day after dose 1

    Description: As measured at the central laboratory

    Measure: Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values

    Time: 7 days after dose 1

    Description: As measured at the central laboratory

    Measure: Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values

    Time: 7 days after dose 2

    Description: As measured at the central laboratory

    Measure: Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments

    Time: Between baseline and 1 day after dose 1

    Description: As measured at the central laboratory

    Measure: Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments

    Time: Between baseline and 7 days after dose 1

    Description: As measured at the central laboratory

    Measure: Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments

    Time: Between before dose 2 and 7 days after dose 2

    Description: Pain at the injection site, redness, and swelling as self-reported on electronic diaries.

    Measure: In the first 360 participants randomized into Phase 2/3, percentage of participants reporting local reactions

    Time: For 7 days after dose 1 and dose 2

    Description: Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.

    Measure: In the first 360 participants randomized into Phase 2/3, percentage of participants reporting systemic events

    Time: For 7 days after dose 1 and dose 2

    Description: As elicited by investigational site staff

    Measure: In the first 360 participants randomized into Phase 2/3, percentage of participants reporting adverse events

    Time: From dose 1 through 1 month after the last dose

    Description: As elicited by investigational site staff

    Measure: In the first 360 participants randomized into Phase 2/3, percentage of participants reporting serious adverse events

    Time: From dose 1 through 6 months after the last dose

    Description: Pain at the injection site, redness, and swelling as self-reported on electronic diaries.

    Measure: In a subset of at least 6000 participants randomized in Phase 2/3, percentage of participants reporting local reactions

    Time: For 7 days after dose 1 and dose 2

    Description: Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.

    Measure: In a subset of at least 6000 participants randomized in Phase 2/3, percentage of participants reporting systemic events

    Time: For 7 days after dose 1 and dose 2

    Description: As elicited by investigational site staff

    Measure: Percentage of participants in Phase 2/3 reporting adverse events

    Time: From dose 1 through 1 month after the last dose

    Description: As elicited by investigational site staff

    Measure: Percentage of participants in Phase 2/3 reporting serious adverse events

    Time: From dose 1 through 6 months after the last dose

    Description: Per 1000 person-years of follow-up

    Measure: Confirmed COVID-19 in Phase 2/3 participants without evidence of infection before vaccination

    Time: From 7 days after the second dose of study intervention to the end of the study, up to 2 years

    Description: Per 1000 person-years of follow-up

    Measure: Confirmed COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination

    Time: From 7 days after the second dose of study intervention to the end of the study, up to 2 years

    Description: As elicited by investigational site staff

    Measure: Percentage of participants 12-15 years of age in Phase 3 reporting adverse events

    Time: From dose 1 through 1 month after the last dose

    Description: As elicited by investigational site staff

    Measure: Percentage of participants 12-15 years of age in Phase 3 reporting adverse events

    Time: From dose 1 through 6 months after the last dose

    Description: Pain at the injection site, redness, and swelling as self-reported on electronic diaries.

    Measure: In participants 12-15 years of age randomized in Phase 3, percentage of participants reporting local reactions

    Time: For 7 days after dose 1 and dose 2

    Description: Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.

    Measure: In participants 12-15 years of age randomized in Phase 3, percentage of participants reporting systemic events

    Time: For 7 days after dose 1 and dose 2

    Secondary Outcomes

    Description: As measured at the central laboratory

    Measure: In Phase 1 participants, SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs

    Time: Through 2 years after the final dose

    Description: As measured at the central laboratory

    Measure: In Phase 1 participants, GMFR in SARS-CoV-2 serum neutralizing titers from before vaccination to each subsequent time point

    Time: Through 2 years after the final dose

    Description: As measured at the central laboratory

    Measure: Proportion of participants in Phase 1 achieving a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 serum neutralizing antibody levels

    Time: Through 2 years after the final dose

    Description: As measured at the central laboratory

    Measure: In Phase 1 participants, SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels, expressed as GMCs

    Time: Through 2 years after the final dose

    Description: As measured at the central laboratory

    Measure: Proportion of participants in Phase 1 achieving a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels

    Time: Through 2 years after the final dose

    Description: As measured at the central laboratory

    Measure: In Phase 1 participants, GMFR in SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels from before vaccination to each subsequent time point

    Time: Through 2 years after the final dose

    Description: As measured at the central laboratory

    Measure: In Phase 1 participants, GMR of the geometric mean of SARS-CoV-2 serum neutralizing titers to the geometric mean of SARS CoV 2 (anti-S1 and anti-RBD) binding antibody levels

    Time: Through 2 years after the final dose

    Description: Per 1000 person-years of follow-up

    Measure: Confirmed COVID-19 in Phase 2/3 participants without evidence of infection before vaccination

    Time: From 14 days after the second dose of study intervention to the end of the study, up to 2 years

    Description: Per 1000 person-years of follow-up

    Measure: Confirmed COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination

    Time: From 14 days after the second dose of study intervention to the end of the study, up to 2 years

    Description: Per 1000 person-years of follow-up

    Measure: Confirmed severe COVID-19 in Phase 2/3 participants without evidence of infection before vaccination

    Time: From 7 days after the second dose of study intervention to the end of the study, up to 2 years

    Description: Per 1000 person-years of follow-up

    Measure: Confirmed severe COVID-19 in Phase 2/3 participants without evidence of infection before vaccination

    Time: From 14 days after the second dose of study intervention to the end of the study, up to 2 years

    Description: Per 1000 person-years of follow-up

    Measure: Confirmed severe COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination

    Time: From 7 days after the second dose of study intervention to the end of the study, up to 2 years

    Description: Per 1000 person-years of follow-up

    Measure: Confirmed severe COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination

    Time: From 14 days after the second dose of study intervention to the end of the study, up to 2 years

    Description: Per 1000 person-years of follow-up

    Measure: Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants without evidence of infection before vaccination

    Time: From 7 days after the second dose of study intervention to the end of the study, up to 2 years

    Description: Per 1000 person-years of follow-up

    Measure: Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants without evidence of infection before vaccination

    Time: From 14 days after the second dose of study intervention to the end of the study, up to 2 years

    Description: Per 1000 person-years of follow-up

    Measure: Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants with and without evidence of infection before vaccination

    Time: From 7 days after the second dose of study intervention to the end of the study, up to 2 years

    Description: Per 1000 person-years of follow-up

    Measure: Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants with and without evidence of infection before vaccination

    Time: From 14 days after the second dose of study intervention to the end of the study, up to 2 years

    Description: As measured at the central laboratory

    Measure: GMR of SARS CoV 2 neutralizing titers in the 2 age groups (12-15 years of age to 16-25 years of age)

    Time: 1 month after the second dose
    6 A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older

    The mRNA-1273 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed to primarily evaluate the efficacy, safety, and immunogenicity of mRNA-1273 to prevent COVID-19 for up to 2 years after the second dose of mRNA-1273.

    NCT04470427
    Conditions
    1. SARS-CoV-2
    Interventions
    1. Biological: mRNA-1273
    2. Biological: Placebo

    Primary Outcomes

    Measure: Number of Participants with a First Occurrence of COVID-19 Starting 14 Days after Second Dose of mRNA-1273

    Time: Day 29 (second dose) up to Day 759 (2 years after second dose)

    Measure: Number of Participants with Adverse Events (AEs) or Medically Attended AEs (MAAEs) Leading to Withdrawal

    Time: Up to Day 759 (2 years after second dose)

    Measure: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)

    Time: Up to Day 8 (7 days after first dose) and up to Day 36 (7 days after second dose)

    Measure: Number of Participants with Unsolicited AEs

    Time: Up to Day 57 (28 days after each dose)

    Secondary Outcomes

    Description: Clinical signs indicative of severe COVID-19 as predefined for the study.

    Measure: Number of Participants with a First Occurrence of Severe COVID-19 Starting 14 Days after Second Dose of mRNA-1273

    Time: Day 29 (second dose) up to Day 759 (2 years after second dose)

    Description: Clinical signs indicative of COVID-19 and SARS-CoV-2 Infection as predefined for the study.

    Measure: Number of Participants with a First Occurrence of Either COVID-19 or SARS-CoV-2 Infection regardless of symptomatology or Severity Starting 14 Days after Second Dose of mRNA-1273 or Placebo

    Time: Day 29 (second dose) up to Day 759 (2 years after second dose)]

    Description: Clinical signs indicative of secondary case definition of COVID-19 as predefined for the study.

    Measure: Number of Participants with a Secondary Case Definition of COVID-19 Starting 14 days after Second Dose of mRNA-1273 or Placebo

    Time: Day 29 (second dose) up to Day 759 (2 years after second dose)

    Description: Clinical signs indicative of COVID-19 as predefined for the study.

    Measure: Number of Participants with a First Occurrence of COVID-19 Starting 14 days after First Dose of mRNA-1273 or Placebo

    Time: Day 1 (first dose) up to Day 759 (2 years after second dose)

    Description: Clinical signs indicative of COVID-19 and SARS-CoV-2 infection as predefined for the study.

    Measure: Number of Participants with a First Occurrence of COVID-19 Starting 14 days after Second Dose of mRNA-1273 or Placebo regardless of evidence of prior SARS-CoV-2 Infection

    Time: Day 29 (second dose) up to Day 759 (2 years after second dose)

    Description: Clinical signs indicative of COVID-19 and SARS-CoV-2 infection as predefined for the study.

    Measure: Number of Participants with a First Occurrence of SARS-CoV-2 Infection in the Absence of Symptoms Defining COVID-19 Starting 14 days after Second Dose of mRNA-1273 or Placebo

    Time: Day 29 (second dose) up to Day 759 (2 years after second dose)

    Measure: Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (nAb)

    Time: Day 1, Day 29, Day 57, Day 209, Day 394, and Day 759

    Measure: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific nAb

    Time: Day 1, Day 29, Day 57, Day 209, Day 394, and Day 759

    Measure: Quantified Levels or GMT of S Protein-Specific Binding Antibody (bAb)

    Time: Day 1, Day 29, Day 57, Day 209, Day 394, and Day 759

    Measure: GMFR of S Protein Specific bAb

    Time: Day 1, Day 29, Day 57, Day 209, Day 394, and Day 759
    7 A Phase 2/3, Randomized, Observer-Blind, Placebo Controlled Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273 SARS CoV 2 Vaccine in Healthy Adolescents 12 to <18 Years of Age

    The mRNA-1273 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed to primarily evaluate the safety and reactogenicity of a single dose level of mRNA-1273 vaccine administered in 2 doses 28 days apart to an adolescent population.

    NCT04649151
    Conditions
    1. SARS-CoV-2
    Interventions
    1. Biological: mRNA-1273
    2. Biological: Placebo

    Primary Outcomes

    Measure: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)

    Time: Up to Day 8 (7 days after first dose) and up to Day 36 (7 days after second dose)

    Measure: Number of Participants with Unsolicited Adverse Events (AEs)

    Time: Up to Day 57 (28 days after each dose)

    Measure: Number of Participants with Serious Adverse Events (SAEs), Medically Attended AEs (MAAEs), or Adverse Events of Special Interest (AESI)

    Time: Up to Day 394 (1 year after second dose)

    Description: Acceptable serum Ab threshold as predefined for the study.

    Measure: Number of Participants Who have Reached the Acceptable Threshold for the Serum Ab Level at Day 57

    Time: Day 57 (28 days after second dose)

    Measure: Comparison of the Geometric Mean of the Serum Neutralizing Antibody (nAb) level against the Geometric Mean of the Serum nAb level in Study mRNA-1273-P301 (NCT04470427)

    Time: Day 57 (28 days after second dose)

    Secondary Outcomes

    Measure: Geometric Mean Value of SARS-CoV-2 Spike Protein (S2P)-specific binding antibody (bAb)

    Time: Day 1, Day 57 (1 month after dose 2), Day 209 (6 months after dose 2), and Day 394 (1 year after dose 2)

    Measure: Geometric Mean Value of SARS-CoV-2-specific nAb

    Time: Day 1, Day 57 (1 month after dose 2), Day 209 (6 months after dose 2), and Day 394 (1 year after dose 2)

    Description: Clinical signs indicative of SARS-CoV-2 infection as predefined for the study.

    Measure: Number of Participants with a SARS-CoV-2 Infection Starting on Day 57

    Time: Day 57 up to Day 394

    Description: Clinical signs indicative of COVID-19 as predefined for the study.

    Measure: Number of Participants with a First Occurrence of COVID-19 Starting 14 days after Second Dose of mRNA-1273 or Placebo

    Time: Day 29 (second dose) up to Day 394 (1 year after second dose)
    8 A Phase 2a, Randomized, Observer-Blind, Placebo Controlled, Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 SARS-COV-2 Vaccine in Adults Aged 18 Years and Older

    This clinical study will assess the safety, reactogenicity, and immunogenicity of 2 dose levels of mRNA-1273 SARS-COV-2 vaccine in adults 18 years of age or older.

    NCT04405076
    Conditions
    1. SARS-CoV-2
    Interventions
    1. Biological: Biological: mRNA-1273: 50 mcg
    2. Other: Placebo
    3. Biological: Biological: mRNA-1273: 100 mcg

    Primary Outcomes

    Measure: Solicited local and systemic adverse reactions (ARs)

    Time: 7 days post-vaccination

    Measure: Unsolicited adverse events (AEs)

    Time: 28 days post-vaccination

    Measure: Medically-attended adverse events (MAAEs)

    Time: Month 0 through Month 13

    Measure: Serious adverse events (SAEs)

    Time: Month 0 through Month 13

    Measure: Change in the measure of clinical safety laboratory values in Cohort 2 from baseline

    Time: Through 1 month after last vaccination

    Measure: The number and percentage of participants with abnormalities in blood pressure, temperature, HR or respiratory rate will be assessed.

    Time: Through 1 year after last vaccination

    Measure: The number and percentage of participants with abnormalities in physical examinations will be assessed

    Time: Through 1 year after last vaccination

    Measure: Evaluate immunogenicity of mRNA-1273 by titer of SARS-CoV-2-specific binding antibody (bAb) measured by enzyme-linked immunosorbent assay (ELISA)

    Time: Through 1 year after the final dose

    Secondary Outcomes

    Measure: Titer of SARS-CoV-2-specific neutralizing antibody (nAb)

    Time: Through 1 year post last vaccination

    Description: Seroconversion as measured by an increase of SARS-CoV-2-specific neutralizing antibody (nAb) titer either from below the limit of detection (LOD) or lower limit of quantification (LLOQ) to equal to or above LOD or LLOQ, or a 4-times higher titer in participants with pre-existing nAb titers.

    Measure: Seroconversion as measured by an increase of SARS-CoV-2-specific neutralizing antibody (nAb) titer

    Time: Through 1 year post last vaccination
    9 A Phase 2A/B, Randomized, Observer-blinded, Placebo-controlled Study to Evaluate the Efficacy, Immunogenicity, and Safety of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) With Matrix-M1™ Adjuvant in South African Adult Subjects Living Without HIV; and Safety and Immunogenicity in Adults Living With HIV

    This is a study to evaluate the effectiveness and safety of a coronavirus disease 2019 (COVID-19) vaccine called SARS-CoV-2 rS with Matrix-M1 adjuvant in a minimum of approximately 2,960 to a maximum of approximately 4,164 healthy HIV-negative (HIV-) adult participants and in approximately 240 medically stable HIV-positive (HIV+) adult participants in up to 15 sites across South Africa. A vaccine causes the body to have an immune response that may help prevent the infection or reduce the severity of symptoms. An adjuvant is something that can make a vaccine work better. This study will look at the protective effect, body's immune response, and safety of SARS-CoV-2 rS with Matrix-M1 adjuvant in these study populations. Participants in the study will randomly be assigned to receive SARS-CoV-2 rS with Matrix-M1 adjuvant or placebo. Each participant in the study will receive a total of 2 intramuscular injections over the course of the study.

    NCT04533399
    Conditions
    1. SARS-CoV-2 Infection
    2. COVID-19
    Interventions
    1. Biological: SARS-CoV-2 rS/Matrix-M1 Adjuvant
    2. Other: Placebo

    Primary Outcomes

    Description: Number of human immunodeficiency virus negative (HIV-) participants with first occurrence of positive (+) polymerase chain reaction (PCR), (+) PCR-confirmed, SARS-CoV-2 illness with symptomatic mild, moderate, or severe COVID-19 assessed from Day 28 (7 days after second vaccination dose) through the length of the study.

    Measure: Cohort 1: HIV- Participants with Symptomatic Mild, Moderate, or Severe COVID-19

    Time: Day 28 to Day 386

    Description: Number of HIV- participants with first occurrence of (+) PCR-confirmed SARS-CoV-2 illness with symptomatic moderate or severe COVID-19 assessed from Day 28 (7 days after second vaccination) through the length of the study.

    Measure: Cohort 1: HIV- Participants with Symptomatic Moderate or Severe COVID-19

    Time: Day 28 to Day 386

    Description: Numbers and percentages (with 95% confidence intervals [CIs]) of HIV- participants with solicited AEs, local and systemic, for 7 days following each vaccination (Days 0 and 21) by severity score, duration, and peak intensity.

    Measure: Cohort 1: HIV- Participants with Solicited Adverse Events (AEs)

    Time: 28 days

    Description: Numbers and percentages (with 95% CI) of HIV- participants with unsolicited AEs (eg, treatment-emergent, serious, suspected unexpected serious, those of special interest, MAAEs) through Day 35 by Medical Dictionary for Regulatory Activities (MedDRA) classification, severity score, and relatedness.

    Measure: Cohort 1: HIV- Participants with Unsolicited AEs

    Time: 35 days

    Description: Numbers and percentages (with 95% CIs) of HIV+ participants with solicited AEs, local and systemic, for 7 days following each vaccination (Days 0 and 21) by severity score, duration, and peak intensity.

    Measure: Cohort 2: HIV+ Participants with Solicited AEs

    Time: 28 days

    Description: Numbers and percentages (with 95% CI) of HIV+ participants with unsolicited AEs (eg, treatment-emergent, serious, suspected unexpected serious, those of special interest, MAAEs) through Day 35 by MedDRA classification, severity score, and relatedness.

    Measure: Cohort 2: HIV+ Participants with Unsolicited AEs

    Time: 35 days

    Description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by enzyme-linked immunosorbent assay (ELISA) expressed as GMTs at Day 35.

    Measure: Cohort 2: Serum Immunoglobulin G (IgG) Antibody Levels Expressed as Geometric Mean Titers (GMTs)

    Time: Day 35

    Description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs at Day 35.

    Measure: Cohort 2: Serum IgG Antibody Levels Expressed as Geometric Mean Fold Rises (GMFRs)

    Time: Day 35

    Description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as SCR at Day 35. SCR is defined as the percentage of participants with a post-vaccination titer ≥ 4 fold over naïve background and ≥ 2 fold over pre existing titer.

    Measure: Cohort 2: Serum IgG Antibody Levels Expressed as Seroconversion Rates (SCRs)

    Time: Day 35

    Secondary Outcomes

    Description: Number of HIV- participants with first occurrence of (+) PCR-confirmed SARS-CoV-2 illness in terms of individual strata of symptomatic virologically confirmed, mild, moderate, or severe COVID-19.

    Measure: Cohort 1: HIV- Participants with Individual Strata of Symptomatic Virologically Confirmed, Mild, Moderate, or Severe COVID-19

    Time: Day 28 to Day 386

    Description: Number of HIV- participants with first occurrence of (+) PCR-confirmed SARS-CoV-2 illness with COVID-19 requiring hospitalization.

    Measure: Cohort 1: HIV- Participants with COVID-19 Requiring Hospitalization

    Time: Day 28 to Day 386

    Description: Incidence, maximum severity score, and symptom duration of SARS-CoV-2 infection by classification of symptomatic virologically confirmed, mild, moderate, and/or severe disease in HIV- participants.

    Measure: Cohort 1: Incidence, Maximum Severity Score, and Symptom Duration of SARS-CoV-2 Infection by Severity Classification

    Time: Day 28 to Day 386

    Description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMTs at Days 0 (baseline), 21 (post first dose), and at 3 and 6 months after the last vaccination in HIV- participants.

    Measure: Cohort 1: Serum IgG Antibody Levels at Multiple Time Points Expressed as GMTs

    Time: Day 0 to 6 months after the last vaccination

    Description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs at Days 0 (baseline), 21 (post first dose), and at 3 and 6 months after the last vaccination in HIV- participants.

    Measure: Cohort 1: Serum IgG Antibody Levels at Multiple Time Points Expressed as GMFRs

    Time: Day 0 to 6 months after the last vaccination

    Description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as SCRs at Days 0 (baseline), 21 (post first dose), and at 3 and 6 months after the last vaccination in HIV- participants. SCR is defined as the percentage of participants with a post-vaccination titer ≥ 4 fold over naïve background and ≥ 2 fold over pre-existing titer.

    Measure: Cohort 1: Serum IgG Antibody Levels at Multiple Time Points Expressed as SCRs

    Time: Day 0 to 6 months after the last vaccination

    Description: Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by ACE2 receptor binding inhibition assay expressed as GMTs at Days 0 (baseline), 21 (post first dose), 35 (post second dose), and at 3 and 6 months after the last vaccination in HIV- participants.

    Measure: Cohort 1: Angiotensin-Converting Enzyme 2 (ACE2) Receptor Binding Inhibition Assay Expressed as GMTs

    Time: Day 0 to 6 months after the last vaccination

    Description: Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by ACE2 receptor binding inhibition assay expressed as GMFRs at Days 0 (baseline), 21 (post first dose), 35 (post second dose), and at 3 and 6 months after the last vaccination in HIV- participants.

    Measure: Cohort 1: ACE2 Receptor Binding Inhibition Assay Expressed as GMFRs

    Time: Day 0 to 6 months after the last vaccination

    Description: Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by ACE2 receptor binding inhibition assay expressed as SCRs at Days 0 (baseline), 21 (post first dose), 35 (post second dose), and at 3 and 6 months after the last vaccination in HIV- participants.

    Measure: Cohort 1: ACE2 Receptor Binding Inhibition Assay Expressed as SCRs

    Time: Day 0 to 6 months after the last vaccination

    Description: Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by ACE2 receptor binding inhibition assay expressed as SRRs at Days 0 (baseline), 21 (post first dose), 35 (post second dose), and at 3 and 6 months after the last vaccination in HIV- participants. SRR is defined as the proportion of participants with rises in titers exceeding the 95th percentile of placebo participants at the same time point and based on prior SARS-CoV-2 exposure.

    Measure: Cohort 1: ACE2 Receptor Binding Inhibition Assay Expressed as Seroresponse Rates (SRRs)

    Time: Day 0 to 6 months after the last vaccination

    Description: Neutralizing antibody activity as detected by microneutralization assay (MN) as expressed as GMTs at Days 0 (baseline), 35 (post second dose), and at 3 and 6 months after the last vaccination in HIV- participants.

    Measure: Cohort 1: Neutralizing Antibody Activity Expressed as GMTs

    Time: Day 0 to 6 months after the last vaccination

    Description: Neutralizing antibody activity as detected by MN expressed as GMFRs at Days 0 (baseline), 35 (post second dose), and at 3 and 6 months after the last vaccination in HIV-participants.

    Measure: Cohort 1: Neutralizing Antibody Activity Expressed as GMFRs

    Time: Day 0 to 6 months after the last vaccination

    Description: Neutralizing antibody activity as detected by MN expressed as SCRs (≥ 4 fold change) at Days 0 (baseline), 35 (post second dose), and at 3 and 6 months after the last vaccination in HIV- participants.

    Measure: Cohort 1: Neutralizing Antibody Activity Expressed as SCRs

    Time: Day 0 to 6 months after the last vaccination

    Description: Neutralizing antibody activity as detected by MN expressed as SRRs at Days 0 (baseline), 35 (post second dose), and at 3 and 6 months after the last vaccination in HIV-participants.

    Measure: Cohort 1: Neutralizing Antibody Activity Expressed as SRRs

    Time: Day 0 to 6 months after the last vaccination

    Description: Numbers and percentages (with 95% CI) of participants with MAAEs, AESI, or SAE through End of Study by MedDRA classification, severity score, and relatedness in HIV- participants.

    Measure: Cohort 1: HIV- Participants with Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs)

    Time: 386 days

    Description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMTs at Days 0 (baseline), 21 (post first dose), and at 3 and 6 months after the last vaccination in HIV+ participants.

    Measure: Cohort 2: Serum IgG Antibody Levels at Multiple Time Points Expressed as GMTs

    Time: Day 0 to 6 months after the last vaccination

    Description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs at Days 0 (baseline), 21 (post first dose), and at 3 and 6 months after the last vaccination in HIV+ participants.

    Measure: Cohort 2: Serum IgG Antibody Levels at Multiple Time Points Expressed as GMFRs

    Time: Day 0 to 6 months after the last vaccination

    Description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as SCRs at Days 0 (baseline), 21 (post first dose), and at 3 and 6 months after the last vaccination in HIV+ participants. SCR is defined as the percentage of participants with a post-vaccination titer ≥ 4 fold over naïve background and ≥ 2 fold over pre-existing titer.

    Measure: Cohort 2: Serum IgG Antibody Levels at Multiple Time Points Expressed as SCRs

    Time: Day 0 to 6 months after the last vaccination

    Description: Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by ACE2 receptor binding inhibition assay expressed as GMTs at Days 0 (baseline), 21 (post first dose), 35 (post second dose), and at 3 and 6 months after the last vaccination in HIV+ participants.

    Measure: Cohort 2: ACE2 Receptor Binding Inhibition Assay Expressed as GMTs

    Time: Day 0 to 6 months after the last vaccination

    Description: Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by ACE2 receptor binding inhibition assay expressed as GMFRs at Days 0 (baseline), 21 (post first dose), 35 (post second dose), and at 3 and 6 months after the last vaccination in HIV+ participants.

    Measure: Cohort 2: ACE2 Receptor Binding Inhibition Assay Expressed as GMFRs

    Time: Day 0 to 6 months after the last vaccination

    Description: Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by ACE2 receptor binding inhibition assay expressed as SCRs at Days 0 (baseline), 21 (post first dose), 35 (post second dose), and at 3 and 6 months after the last vaccination in HIV+ participants.

    Measure: Cohort 2: ACE2 Receptor Binding Inhibition Assay Expressed as SCRs

    Time: Day 0 to 6 months after the last vaccination

    Description: Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by ACE2 receptor binding inhibition assay expressed as SRRs at Days 0 (baseline), 21 (post first dose), 35 (post second dose), and at 3 and 6 months after the last vaccination in HIV+ participants. SRR is defined as the proportion of participants with rises in titers exceeding the 95th percentile of placebo participants at the same time point and based on prior SARS-CoV-2 exposure.

    Measure: Cohort 2: ACE2 Receptor Binding Inhibition Assay Expressed as SRRs

    Time: Day 0 to 6 months after the last vaccination

    Description: Neutralizing antibody activity as detected by MN as expressed as GMTs at Days 0 (baseline), 35 (post second dose), and at 3 and 6 months after the last vaccination in HIV+ participants.

    Measure: Cohort 2: Neutralizing Antibody Activity Expressed as GMTs

    Time: Day 0 to 6 months after the last vaccination

    Description: Neutralizing antibody activity as detected by MN expressed as GMFRs at Days 0 (baseline), 35 (post second dose), and at 3 and 6 months after the last vaccination in HIV+ participants.

    Measure: Cohort 2: Neutralizing Antibody Activity Expressed as GMFRs

    Time: Day 0 to 6 months after the last vaccination

    Description: Neutralizing antibody activity as detected by MN expressed as SCRs (≥ 4 fold change) at Days 0 (baseline), 35 (post second dose), and at 3 and 6 months after the last vaccination in HIV+ participants.

    Measure: Cohort 2: Neutralizing Antibody Activity Expressed as SCRs

    Time: Day 0 to 6 months after the last vaccination

    Description: Neutralizing antibody activity as detected by MN expressed as SRRs at Days 0 (baseline), 35 (post second dose), and at 3 and 6 months after the last vaccination in HIV+ participants.

    Measure: Cohort 2: Neutralizing Antibody Activity Expressed as SRRs

    Time: Day 0 to 6 months after the last vaccination

    Description: Numbers and percentages (with 95% CI) of participants with MAAEs, AESI, or SAE through End of Study by MedDRA classification, severity score, and relatedness in HIV+ participants.

    Measure: Cohort 2: HIV+ Participants with MAAEs, AESIs, and SAEs

    Time: 386 days

    Description: Counts and proportions of symptomatic virologically confirmed, mild, moderate, and severe COVID-19 outcomes in HIV+ participants as previously described in the second primary efficacy endpoint for Cohort 1 (HIV- participants).

    Measure: Cohort 2: HIV+ Participants with Symptomatic Virologically Confirmed, Mild, Moderate, or Severe COVID-19

    Time: Day 28 to Day 385

    Description: Incidence, maximum severity score, and symptom duration of SARS-CoV-2 infection by classification of symptomatic virologically confirmed, mild, moderate, and/or severe disease in HIV+ participants.

    Measure: Cohort 2: Incidence, Maximum Severity Score, and Symptom Duration of SARS-CoV-2 Infection by Severity Classification

    Time: Day 28 to Day 385
    10 A Phase 3, Randomized, Observer-Blinded, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) With Matrix-M1™ Adjuvant in Adult Participants ≥ 18 Years

    This is a study to evaluate the effectiveness, immune response, and safety of a coronavirus disease 2019 (COVID-19) vaccine called SARS-CoV-2 rS with Matrix-M1 adjuvant in adults 18 years of age and older in the United States and Mexico. A vaccine causes the body to have an immune response that may help prevent the infection or reduce the severity of symptoms. An adjuvant is something that can make a vaccine work better. This study will look at the protective effect, body's immune response, and safety of SARS-CoV-2 rS with Matrix-M1 adjuvant in the study population. Participants in the study will randomly be assigned to receive SARS-CoV-2 rS with Matrix-M1 adjuvant or placebo. Each participant in the study will receive a total of 2 intramuscular injections over the course of the study. Up to 30,000 participants will take part in the study.

    NCT04611802
    Conditions
    1. SARS-CoV Infection
    2. Covid19
    Interventions
    1. Biological: SARS-CoV-2 rS/Matrix-M1 Adjuvant
    2. Other: Placebo
    MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

    Primary Outcomes

    Description: Number of participants with first occurrence of positive (+) polymerase chain reaction (PCR)-confirmed SARS-CoV-2 illness with symptomatic mild, moderate, or severe COVID-19, with each symptom lasting for at least 2 consecutive days, with onset from Day 28 (7 days after second vaccination dose) through the length of the study.

    Measure: Participants with Symptomatic Mild, Moderate, or Severe Coronavirus Disease 2019 (COVID-19)

    Time: Day 28 to Day 750

    Secondary Outcomes

    Description: Number of participants with first occurrence of (+) PCR-confirmed SARS-CoV-2 illness with symptomatic moderate or severe COVID-19, with each symptom lasting for at least 2 consecutive days, with onset from Day 28 (7 days after second vaccination dose) through the length of the study.

    Measure: Participants with Symptomatic Moderate or Severe COVID-19

    Time: Day 28 to Day 750

    Description: Number of participants with first occurrence of (+) PCR-confirmed SARS-CoV-2 illness with any symptomatic COVID-19, with each symptom lasting for at least 2 consecutive days, with onset from Day 28 (7 days after second vaccination dose) through the length of the study.

    Measure: Participants with Any Symptomatic COVID-19

    Time: Day 28 to Day 750

    Description: Neutralizing antibody activity as detected by microneutralization assay (MN) as expressed as GMTs at Days 0, 35 and Month 3.

    Measure: Neutralizing Antibody Activity Expressed as Geometric Mean Titers (GMTs)

    Time: Day 0 to Day 105

    Description: Neutralizing antibody activity as detected by MN as expressed as GMFRs at Days 0, 35 and Month 3.

    Measure: Neutralizing Antibody Activity Expressed as Geometric Mean Fold Rises (GMFRs)

    Time: Day 0 to Day 105

    Description: Serum IgG antibody levels specific to SARS-CoV-2 rS protein antigen(s) as detected by enzyme-linked immunosorbent assay (ELISA) expressed as GMTs at Days 0, 35 and Month 3.

    Measure: Serum Immunoglobulin G (IgG) Antibody Levels Expressed as GMTs

    Time: Day 0 to Day 105

    Description: Serum IgG antibody levels specific to SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs at Days 0, 35 and Month 3.

    Measure: Serum IgG Antibody Levels Expressed as GMFRs

    Time: Day 0 to Day 105

    Description: Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by hACE2 receptor binding inhibition assay expressed as GMTs at Days 0, 35 and Month 3.

    Measure: Human Angiotensin-Converting Enzyme 2 (hACE2) Receptor Binding Inhibition Assay Expressed as GMTs

    Time: Day 0 to Day 105

    Description: Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by hACE2 receptor binding inhibition assay expressed as GMFRs at Days 0, 35 and Month 3.

    Measure: hACE2 Receptor Binding Inhibition Assay Expressed as GMFRs

    Time: Day 0 to Day 105

    Description: Serum IgG antibody levels specific to SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMTs at Months 6, 12, 18, and 24.

    Measure: Serum Immunoglobulin G (IgG) Antibody Levels Expressed as GMTs at Later Time Points

    Time: Day 165 to Day 750

    Description: Serum IgG antibody levels specific to SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs at Months 6, 12, 18, and 24.

    Measure: Serum Immunoglobulin G (IgG) Antibody Levels Expressed as GMFRs at Later Time Points

    Time: Day 165 to Day 750

    Description: Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by hACE2 receptor binding inhibition assay expressed as GMTs at Months 6, 12, 18, and 24.

    Measure: hACE2 Receptor Binding Inhibition Assay Expressed as GMTs at Later Time Points

    Time: Day 165 to Day 750

    Description: Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by hACE2 receptor binding inhibition assay expressed as GMFRs at Months 6, 12, 18, and 24.

    Measure: hACE2 Receptor Binding Inhibition Assay Expressed as GMFRs at Later Time Points

    Time: Day 165 to Day 750

    Description: Neutralizing antibody activity as detected by MN as expressed as GMTs at Months 6, 12, 18, and 24.

    Measure: Neutralizing Antibody Activity Expressed as GMTs at Later Time Points

    Time: Day 165 to Day 750

    Description: Neutralizing antibody activity as detected by MN as expressed as GMFRs at Months 6, 12, 18, and 24.

    Measure: Neutralizing Antibody Activity Expressed as GMFRs at Later Time Points

    Time: Day 165 to Day 750

    Description: Description of course, treatment and severity of COVID-19 reported after a PCR-confirmed case via the Endpoint Form.

    Measure: Description of Course, Treatment and Severity of COVID-19

    Time: Day 28 to Day 750

    Description: Reactogenicity incidence and severity (mild, moderate or severe) recorded by all participants on their electronic patient-reported outcome diary application (eDiary) on days of vaccination and subsequent 6 days (total 7 days after each vaccine injection).

    Measure: Reactogenicity Incidence and Severity

    Time: Day 0 to Day 27

    Description: Number of participants with mild, moderate, or severe MAAEs through Day 49.

    Measure: Incidence and Severity of Medically Attended Adverse Events (MAAEs) Through Day 49.

    Time: Day 0 to Day 49

    Description: Number of participants with mild, moderate, or severe AEs through Day 49.

    Measure: Incidence and Severity of Unsolicited Adverse Events (AEs) Through Day 49.

    Time: Day 0 to Day 49

    Description: Number of participants with mild, moderate, or severe MAAEs attributed to study vaccine through Month 12.

    Measure: Incidence and Severity of MAAEs Attributed to Study Vaccine Through Month 12.

    Time: Day 0 to Day 375

    Description: Number of participants with mild, moderate, or severe SAEs through Month 12.

    Measure: Incidence and Severity of Serious Adverse Events (SAEs) Through Month 12.

    Time: Day 0 to Day 375

    Description: Number of participants with mild, moderate, or severe AESIs through Month 12.

    Measure: Incidence and Severity of Adverse Events of Special Interest (AESIs) Through Month 12.

    Time: Day 0 to Day 375

    Description: Number of participants with mild, moderate, or severe SAEs from Month 12 to Month 24.

    Measure: Incidence and Severity of SAEs from Month 12 to Month 24.

    Time: Day 360 to Day 750

    Description: Number of participants with mild, moderate, or severe MAAEs attributed to study vaccine from Month 12 to Month 24.

    Measure: Incidence and Severity of MAAEs Attributed to Study Vaccine from Month 12 to Month 24.

    Time: Day 360 to Day 750

    Description: Number of participants with mild, moderate, or severe AESIs attributed to study vaccine from Month 12 to Month 24.

    Measure: Incidence and Severity of AESIs from Month 12 to Month 24.

    Time: Day 360 to Day 750

    Description: Number of participants who died during the study due to any cause.

    Measure: Deaths Due to Any Cause

    Time: Day 0 to Day 750

    Description: Number of participants with antibodies to SARS-CoV-2 NP at Days 0 and 35, or Months 3, 6, 12, 18 and 24 to determine natural infection and to determine the incidence of asymptomatic infection acquired during study follow-up.

    Measure: Antibodies to SARS-CoV-2 Nucleoprotein (NP) at Specific Time Points

    Time: Day 0 to Day 750

    Description: Number of participants with antibodies to SARS-CoV-2 NP, regardless of whether the infection was symptomatic.

    Measure: Antibodies to SARS-CoV-2 Nucleoprotein (NP) at Any Time Point

    Time: Day 0 to Day 750

    No related HPO nodes (Using clinical trials)


    HPO

    Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


    No related HPO nodes (Using clinical trials)


    Reports

    Data processed on January 01, 2021.

    An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

    Drug Reports   MeSH Reports   HPO Reports  

    Interventions

    4,818 reports on interventions/drugs

    MeSH

    706 reports on MeSH terms

    HPO

    306 reports on HPO terms

    All Terms

    Alphabetical index of all Terms

    Google Colab

    Python example via Google Colab Notebook