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    SARS-CoV-2 Vaccine

    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 (28)


    Name (Synonyms) Correlation
    drug3923 mRNA-1273 Wiki 0.44
    drug3408 Three doses of placebo at the schedule of day 0, 14, 28 #High-dose group# Wiki 0.38
    drug103 ARCT-021 single dose priming Wiki 0.38
    Name (Synonyms) Correlation
    drug3510 Two doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14 Wiki 0.38
    drug3517 Two doses of placebo at the schedule of day 0, 14 #middle-dose group# Wiki 0.38
    drug457 Biological: mRNA-1273: 50 mcg Wiki 0.38
    drug3409 Three doses of placebo at the schedule of day 0, 14, 28 #middle-dose group# Wiki 0.38
    drug1325 Flu shot Wiki 0.38
    drug2504 Placebo (two doses), priming Wiki 0.38
    drug3519 Two doses of placebo at the schedule of day 0, 28(middle-dose group) Wiki 0.38
    drug3406 Three doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 14, 28 Wiki 0.38
    drug1921 MMR vaccine Wiki 0.38
    drug456 Biological: mRNA-1273: 100 mcg Wiki 0.38
    drug3407 Three doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28 Wiki 0.38
    drug3518 Two doses of placebo at the schedule of day 0, 28(high-dose group) Wiki 0.38
    drug3410 Three doses of placebo at the schedule of day 0, 14, 28(high-dose group) Wiki 0.38
    drug2787 Randomized booster Wiki 0.38
    drug3504 Two doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14 Wiki 0.38
    drug3511 Two doses of middle-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28 Wiki 0.38
    drug105 ARCT-021 two lower dose priming Wiki 0.38
    drug104 ARCT-021 two higher dose priming Wiki 0.38
    drug3405 Three doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28 Wiki 0.38
    drug3516 Two doses of placebo at the schedule of day 0, 14 #High-dose group# Wiki 0.38
    drug3505 Two doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28 Wiki 0.38
    drug2530 Placebo booster Wiki 0.38
    drug2490 Placebo Wiki 0.24
    drug1642 Inactivated SARS-CoV-2 Vaccine (Vero cell) Wiki 0.22
    drug157 Ad26.COV2.S Wiki 0.22

    Correlated MeSH Terms (7)


    Name (Synonyms) Correlation
    D018746 Systemic Inflammatory Response Syndrome NIH 0.38
    D014115 Toxemia NIH 0.38
    D018805 Sepsis NIH 0.38
    Name (Synonyms) Correlation
    D003141 Communicable Diseases NIH 0.15
    D045169 Severe Acute Respiratory Syndrome NIH 0.15
    D018352 Coronavirus Infections NIH 0.12
    D007239 Infection NIH 0.09

    Correlated HPO Terms (1)


    Name (Synonyms) Correlation
    HP:0100806 Sepsis HPO 0.38

    Clinical Trials

    Navigate: Correlations   HPO

    There are 7 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 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
    3 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)
    4 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
    5 Safety, Tolerability and Immunogenicity of a Recombinant SARS-CoV-2 Vaccine (Sf9 Cell) in Chinese Healthy Population Aged 18 Years and Older: A Phase I, Single-center, Randomized, Placebo-controlled, Double-blind Study

    This is a phase I, single-center, randomized, placebo-controlled, double-blind study, to evaluate safety, tolerability and immunogenicity of a recombinant SARS-CoV-2 vaccine (Sf9 cell) in Chinese healthy population aged 18 years and older. After randomization, the trial for each subject will last for approximately 13 months. Screening period is 1 week prior to randomization (Day -7 to Day -1), and each dose of either SARS-CoV-2 vaccine (Sf9 Cell) or placebo will be given intramuscularly (IM) on Day 0 and Day 28 for a two-dose regimen, or on Day 0, Day 14, and Day 28 for a three-dose regimen. Subjects who are ≥18 years old and ≤ 55 years old will be enrolled in adult group, and healthy elderly population who are >55 years old will be enrolled in elderly group. After adult group completes the follow-up 7 days after first vaccination, elderly group will be recruited.

    NCT04530656
    Conditions
    1. COVID-19
    Interventions
    1. Biological: Two doses of middle-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28
    2. Biological: Two doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28
    3. Biological: Three doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 14, 28
    4. Biological: Two doses of placebo at the schedule of day 0, 28(middle-dose group)
    5. Biological: Two doses of placebo at the schedule of day 0, 28(high-dose group)
    6. Biological: Three doses of placebo at the schedule of day 0, 14, 28(high-dose group)

    Primary Outcomes

    Description: Occurrence of solicited AR in the subjects within 7 days after each dose of recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo.

    Measure: Occurrence of adverse reactions (AR) within 7 days after each dose of the recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo.

    Time: 7 days after each dose.

    Secondary Outcomes

    Description: Occurrence of solicited AE in the subjects within 7 days after each dose of recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo.

    Measure: Occurrence of adverse events (AE) within 7 days after each dose of the recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo.

    Time: 7 days after each dose.

    Description: Occurrence of subjects experiencing AE associated with recombinant SARS-CoV-2 vaccine (Sf9 cell) up to Day 28.

    Measure: Occurrence of AE up to Day 28 after prime and boost vaccination.

    Time: Day 28 after prime and boost vaccination.

    Description: The proportion of subjects experiencing SAEs up to Day 28 after prime and boost vaccination.

    Measure: The proportion of SAEs up to Day 28 after prime and boost vaccination.

    Time: Day 28 after prime and boost vaccination.

    Description: Month 12 after prime and boost vaccination.

    Measure: The proportion of SAEs up to Month 12 after prime and boost vaccination.

    Time: The proportion of subjects experiencing SAEs up to Month 12 after prime and boost vaccination.

    Description: The proportion of subjects experiencing abnormal markers of hematology, blood chemistry and urine analysis within 7 days before prime vaccination and at Day 3 after each dose of recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo.

    Measure: The proportion of abnormal markers of hematology, blood chemistry and urine analysis within 7 days before prime vaccination and at Day 3 after each dose of recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo.

    Time: 7 days before prime vaccination and Day 3 after each dose.

    Description: Geometric mean titer (GMT) of anti-RBD specific antibody at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.

    Measure: GMT of anti-RBD specific antibody at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.

    Time: Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.

    Description: Four-fold increase in anti-RBD specific antibody titers, as compared to baseline, at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.

    Measure: Four-fold increase in anti-RBD specific antibody titers, at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.

    Time: Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.

    Description: Geometric mean fold increase (GMFI) of anti-RBD specific antibody at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.

    Measure: GMFI of anti-RBD specific antibody at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.

    Time: Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.

    Description: Geometric mean titer (GMT) of SARS-CoV-2 neutralizing antibody (including pseudovirus and live virus-based SARS-CoV-2 neutralizing antibody assay) at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after prime and boost vaccination.

    Measure: GMT of SARS-CoV-2 neutralizing antibody at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.

    Time: Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.

    Description: Four-fold increase in SARS-CoV-2 neutralizing antibody titers (including pseudovirus and live virus-based SARS-CoV-2 neutralizing antibody assay), as compared to baseline, at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.

    Measure: Four-fold increase in SARS-CoV-2 neutralizing antibody titers, at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.

    Time: Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.

    Description: Geometric mean fold increase (GMFI) of SARS-CoV-2 neutralizing antibody (including pseudovirus and live virus-based SARS-CoV-2 neutralizing antibody assay) at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.

    Measure: GMFI of SARS-CoV-2 neutralizing antibody at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after prime and boost vaccination.

    Time: Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.

    Description: Seroconversion rates of IFN-γ stimulated by the overlapping peptide library of S-RBD protein at Day 14, Day 28 after boost vaccination.

    Measure: Seroconversion rates of IFN-γ stimulated by the overlapping peptide library of S-RBD protein at Day 14, Day 28 after boost vaccination.

    Time: Day 14, Day 28 after boost vaccination.
    6 Safety and Immunogenicity of a Recombinant COVID-19 Vaccine (CHO Cell) in Healthy Population Aged 18 Years and Older: A Phase I Study

    This is a phase I, randomized, placebo-controlled, double-blind study, to evaluate safety and immunogenicity of a recombinant SARS-CoV-2 vaccine (CHO cell) in Chinese healthy population aged 18 years and older. After randomization, the trial for each subject will last for approximately 13 months. Screening period is 1 week prior to randomization (Day -7 to Day -1), and each dose of either SARS-CoV-2 vaccine (CHO Cell) or placebo will be given intramuscularly (IM) on Day 0 and Day 14 for a two-dose regimen, or on Day 0, Day 14, and Day 28 for a three-dose regimen. Subjects who are ≥18 years old and ≤ 59 years old will be enrolled in adult group, and healthy elderly population who are >59 years old will be enrolled in elderly group. After adult group completes the follow-up 7 days after first vaccination, elderly group will be recruited.

    NCT04636333
    Conditions
    1. COVID-19
    Interventions
    1. Biological: Two doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14
    2. Biological: Three doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28
    3. Biological: Two doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14
    4. Biological: Three doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28
    5. Biological: Two doses of placebo at the schedule of day 0, 14 #middle-dose group#
    6. Biological: Three doses of placebo at the schedule of day 0, 14, 28 #middle-dose group#
    7. Biological: Two doses of placebo at the schedule of day 0, 14 #High-dose group#
    8. Biological: Three doses of placebo at the schedule of day 0, 14, 28 #High-dose group#

    Primary Outcomes

    Measure: The proportion of adverse reactions (AR) up to Day 28 after prime and boost vaccination of the recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.

    Time: 28 days after first dose

    Secondary Outcomes

    Measure: The proportion of adverse events (AE) within 7 days after each dose of the recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.

    Time: 7 days after each dose

    Measure: The proportion of abnormal markers of hematology, blood chemistry and urine analysis within 3 days after each dose of the recombinant SARS-CoV-2 vaccine (CHO cell) or placebo

    Time: 3 days after each dose

    Measure: The proportion of serious adverse events up to Month 12 after prime and boost vaccination.

    Time: Month 12 after prime and boost vaccination

    Measure: The proportion of neutralizing antibody positive conversion rate, positive rate, GMT and GMI at Day 14, Day 21, Day 28, Day 42 after prime vaccination of recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.#Day 0, Day 14 vaccination program#

    Time: Day 14, Day 21, Day 28, Day 42 after prime vaccination

    Measure: The proportion of IgG antibody positive rate at Day 14, Day 21, Day 28, Day 42 after prime vaccination of recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.#Day 0, Day 14 vaccination program#

    Time: Day 14, Day 21, Day 28, Day 42 after prime vaccination

    Measure: The proportion of neutralizing antibody positive conversion rate, positive rate, GMT and GM at Day 28, Day 35, Day 42, Day 56 after prime vaccination of recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.#Day 0, Day 14 ,Day 28 vaccination program#

    Time: Day 28, Day 35, Day 42, Day 56 after prime vaccination

    Measure: The proportion of IgG antibody positive rate at Day 28, Day 35, Day 42, Day 56 after prime vaccination of recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.#Day 0, Day 14 ,Day 28 vaccination program#

    Time: Day 28, Day 35, Day 42, Day 56 after prime vaccination

    Other Outcomes

    Measure: The proportion of IFN-γ secreted by T cells at Day 14 after prime vaccination of recombinant SARS-CoV-2 vaccine (CHO cell) or placebo using ELISpot detection method

    Time: Day 14 after prime vaccination of recombinant SARS-CoV-2 vaccine (CHO cell) or placebo

    Description: The units of IL2 and IL6 are both pg/ml

    Measure: Changes in serum cytokine (IL2, IL6) levels from baseline after 3 days of each dose

    Time: 3 days of each dose

    Measure: The proportion of neutralizing antibody and the GMT up to Month 3 after the whole process of vaccination

    Time: Month 3 after the whole process of vaccination

    Measure: The proportion of neutralizing antibody and the GMT up to Month 6 after the whole process of vaccination

    Time: Month 6 after the whole process of vaccination

    Measure: The proportion of neutralizing antibody and the GMT up to Month12 after the whole process of vaccination

    Time: Month 12 after the whole process of vaccination
    7 A Phase 2 Randomized, Observer-Blind, Placebo-Controlled Study to Assess the Safety, Reactogenicity, and Immunogenicity of the SARS CoV-2 Vaccine ARCT-021 in Healthy Adult Participants

    This is a Phase 2, randomized, placebo-controlled, and observer-blind study in healthy adults. The study will evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA vaccine candidate against COVID-19: As 2 doses (at two different dose levels), separated by 28 days or as 1 dose In adults 18 years of age and older

    NCT04668339
    Conditions
    1. Covid19
    2. SARS-CoV Infection
    3. Corona Virus Infection
    Interventions
    1. Biological: ARCT-021 single dose priming
    2. Biological: ARCT-021 two lower dose priming
    3. Biological: ARCT-021 two higher dose priming
    4. Biological: Placebo (two doses), priming
    5. Biological: Randomized booster
    6. Biological: Placebo booster
    MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

    Primary Outcomes

    Description: Adverse events reported daily in a diary that reflect common symptoms or findings at the injection site following vaccination

    Measure: Percentages of participants reporting solicited local adverse events

    Time: for 7 days following each dose administration

    Description: Adverse events reported daily in a diary that reflect generalized symptoms following vaccination

    Measure: Percentages of participants reporting solicited systemic adverse events

    Time: for 7 days following each dose administration

    Description: spontaneously reported adverse events

    Measure: Percentages of participants reporting adverse events

    Time: 28 days following each dose administration

    Description: unsolicited adverse events that meet the definition of serious

    Measure: Percentages of participants reporting serious adverse events

    Time: Day 0 to Day 388

    Description: unsolicited adverse events that lead to healthcare provider visit

    Measure: Percentages of participants reporting medically attended adverse events

    Time: Day 0 to Day 388

    Description: unsolicited adverse events associated with new diagnosis of chronic disease

    Measure: Percentages of participants reporting new onset of chronic disease

    Time: Day 0 to Day 388

    Description: chemistry and hematology

    Measure: Percentages of participants with abnormal chemistry and hematology values

    Time: Day 0 to Day 215

    Description: neutralizing antibody response

    Measure: SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs

    Time: Day 0 to Day 388

    Description: neutralizing antibody response

    Measure: Changes in SARS-CoV-2 serum neutralizing titers from before vaccination to each subsequent time point, expressed as GMFRs

    Time: Through Day 388

    Description: neutralizing antibody response

    Measure: Percentages of participants achieving greater than or equal to 2-fold and 4-fold rises from before vaccination in SARS-CoV-2 serum neutralizing antibody levels

    Time: Through Day 388

    Secondary Outcomes

    Description: SARS-CoV-2 anti S1, RBD, N binding antibody responses

    Measure: SARS-CoV-2 anti-S1, anti-RBD, and anti-N binding antibody levels, expressed as GMCs

    Time: Day 0 to Day 388

    Description: SARS-CoV-2 anti S1, RBD, N binding antibody responses

    Measure: Changes in SARS-CoV-2 anti-S1, anti-RBD, and anti-N binding antibody levels from before vaccination to each subsequent time point, expressed as GMFRs

    Time: Through Day 388

    Description: SARS-CoV-2 anti S1, RBD, N binding antibody responses

    Measure: Percentages of participants achieving greater than or equal to 2-fold and 4-fold rises from before vaccination in SARS-CoV-2 SARS-CoV-2 anti-S1, anti-RBD, and anti-N binding antibody levels

    Time: Through Day 388

    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