Report Sections

See All Reports

  • COVID-19 Vaccine
  • COVID-19 (39) SARS-CoV-2 (39) vaccine (18) Vaccine (14) Safety (11) Coronavirus (10) Immunogenicity (9) SARS-CoV-2 Vaccine (7) Virus Diseases (6) Ad5 (5) COVID-19 Vaccine (5) COVID-19 vaccine (5) vector vaccine (5) BCG (4) Coronavirus Disease 2019 (4) Covid19 (4) coronavirus (4) COVID (3) COVID 19 (3) Coronavirus infection (3) Covid-19 (3) Dose-escalation (3) Messenger RNA (3) Moderna (3) Protection against COVID-19 (3) RNA Vaccine (3) Recombinant vaccine (3) SARS (3) adenoviral vector (3) mRNA-1273 (3) mRNA-1273 vaccine (3) Ad5-nCoV (2) Adenovirus Vector (2) BCG vaccine (2) COVID-19 Prevention (2) COVID19 (2) ChAdOx1 nCov19 (2) Convalescent plasma (2) DNA vaccine (2) Electroporation (2) Health care workers (2) Immunogencity (2) Passive immunization (2) Prevention (2) Reactogenicity (2) SARS-CoV 2 (2) SARS-CoV-2 infection (2) Severe acute respiratory syndrome coronavirus 2 (2) Sputnik V (2) Tolerability (2) Transfusion (2) covid-19 (2) immunogenicity (2) infectious respiratory diseases (2) novel coronavirus (2) sars-cov-2 (2) 2019 novel coronavirus (1) 2019-nCoV (1) 2019-nCoV (mRNA-1273) (1) ACE2 (1) ARDS (1) AT1 (1) AZD1222 vaccine (1) AZD1222 vaccine for COVID-19 Prevention (1) Ad26 (1) Ad26COVS1 (1) Adenovirus V (1) AlloStim (1) Alvelestat (1) Antibodies, Neutralizing (1) Antibodies, viral/blood (1) Antibody (1) BACILLUS CALMETTE-GUÉRIN VACCINATION (1) BBV152 (1) BCG Vaccination (1) BCG Vaccine (1) Bacille Calmette-Guérin (1) Bacillus Calmette-Guerin (1) Bacillus Calmette-Guérin vaccination (1) Blinded (1) CEPI (1) COVID 19 Vaccine (1) COVID 19 Vaccine Arcturus (1) COVID 2019 (1) COVID-1 (1) COVID-19 infection (1) COVID-19 serotherapy (1) COVID-19, Convalescent plasma therapy (1) COVID-19, SARS-CoV-2 Vaccine (1) COVID-19, Vaccine (1) COVID-2019 (1) COVID19 ( Corona Virus Disease -2019) (1) Clinical trials (1) Coronavirus Infection (1) Coronavirus Infections / therapy (1) Coronavirus Virus Diseases (1) Covid 19 (1) Covid-19 CTL (1) Covid19 Vaccine (1) Covigenix VAX-001 (1) Critically ill COVID-19 patients (1) EGF (1) Endosomal toll-like receptor 3 (1) EpiVacCorona (1) Fibrosis secondary to Covid19 infection (1) Gamaleya (1) Health Workers (1) Healthcare workers (1) Healthy (1) Herpes Zoster (1) Heterologous effects (1) Heterologous prime-boost vaccination (1) Human (1) IFN type1 (1) IFNγ enzyme-linked immune absorbent spot (ELISpot) (1) IN01 vaccine (1) INO-4800 (1) Immunemo (1) Immunemodulation (1) Immunization, Passive (1) Immunoglobulin (1) Immunoglobulin fragments (1) Immunologic Factors (1) Immunology (1) Inactivated SARS-CoV-2 Vaccine (1) Inactivated vaccine (1) Inactive Vaccine (1) Infectiology (1) Infection (1) Innate immune training (1) Interferon Gamma (1) Intranasal Vaccine (1) Intravenous Immunoglobulin (IVIG) (1) Isotretinoin (1) LV-DC vaccine (1) Lentiviral vector (1) Lentiviral vector, Covid-19/aAPC vaccine (1) M-M-R II ® (1) MMR vaccine (1) MMR vaccine, Respiratory failure, (1) MVA (1) Non-specific effects of BCG (1) Pandemics (1) Passive Immunization (1) Phase I (1) Pooled convalescent Plasma (1) QazCovid-in®, vaccine, III phase, efficiency, safety, immunogenicity (1) RNA COVID 19 (1) Randomized controlled (1) Recombinant Novel Coronavirus Vaccine (1) Respiratory disease (1) Retrospective Studies (1) SARS (Severe Acute Respiratory Syndrome) (1) SARS CoV 2 (1) SARS-COV-2 (1) SARS-CoV Infection (1) SARS-CoV-2 (Severe Acute respiratory syndrome Coronavirus 2) (1) SARS-CoV-2-specific serum neutralising antibody titer (1) SARS-CoV-2-surrogate viral neutralising antibody (1) SARS-Cov2 spike protein-binding IgG antibody titer (1) SARS-Cov2 spike protein-specific CD4+ and CD8+ T-cells responses (1) SARS-Cov2 spike protein-specific Th1/Th2 polarisation (1) Sars-Cov-2 Virus Infection (1) Sepsis (1) Severe Acute Respiratory Syndrome (SARS) (1) Severe COVID-19 patients (1) Sputnik (1) Systems Biology (1) T Cells (1) Therapeutic Vaccine (1) Transmission (1) VLA2001 (1) VXA-C0V2-1 (1) Vaccination (1) Vaccinology (1) Vaxart oral vaccine (1) adaptive design (1) adenoviral vector vaccine (1) adenovirus vector (1) adjuvant (1) adult (1) allergy and immunology (1) anti-infective (1) clinical trial (1) corona virus infection (1) coronavirus disease 2019 (1) dendritic cell (1) dose-finding (1) efficacy (1) exploratory efficacy (1) healthy adults (1) healthy elderlies (1) healthy volunteer (1) inactivated vaccine (1) inactivated-adjuvanted Sars-Cov-2 virus vaccine (1) infection (1) inflammation (1) intravenous immunogloulin therapy (1) live attenuated (1) live attenuated vaccine (1) lung disease (1) myeloid-derived suppressor cells (1) novel lipid nanoparticles (LNPs)-encapsulated mRNA-based vaccine (1) off-target effects (1) pandemic (1) passive immunization (1) pneumonia (1) preemptive (1) prevention (1) prophylaxis (1) rAd26-S (1) reactivity (1) respiratory disease (1) safety (1) self amplifying RNA vaccine (1) tablet vaccine (1) therapeutic vaccine (1) tolerability (1) trained immunity (1) trained innate immunity (1) vaccination (1) vaccine, I/II phase, safety, immunogenicity, QazCovid-in® (1) vector (1)

    COVID-19 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 (23)


    Name (Synonyms) Correlation
    drug3923 mRNA-1273 Wiki 0.52
    drug1469 High-dose placebo (18-59 years) & Three dose regimen Wiki 0.45
    drug1889 Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen Wiki 0.45
    Name (Synonyms) Correlation
    drug1472 High-dose placebo (60-85 years) & Two dose regimen Wiki 0.45
    drug1470 High-dose placebo (18-59 years) & Two dose regimen Wiki 0.45
    drug1891 Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen Wiki 0.45
    drug3745 avdoralimab Wiki 0.45
    drug1893 Low-dose placebo (18-59 years) & Two dose regimen Wiki 0.45
    drug1895 Low-dose placebo (60-85 years) & Two dose regimen Wiki 0.45
    drug1466 High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen Wiki 0.45
    drug12 0.9% (w/v) saline Wiki 0.45
    drug1468 High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen Wiki 0.45
    drug1888 Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen Wiki 0.45
    drug2812 Recombinant novel coronavirus vaccine (Adenovirus type 5 vector) Wiki 0.45
    drug1465 High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen Wiki 0.45
    drug1892 Low-dose placebo (18-59 years) & Three dose regimen Wiki 0.45
    drug1890 Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen Wiki 0.45
    drug1894 Low-dose placebo (60-85 years) & Three dose regimen Wiki 0.45
    drug1471 High-dose placebo (60-85 years) & Three dose regimen Wiki 0.45
    drug1467 High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen Wiki 0.45
    drug128 AZD1222 Wiki 0.40
    drug394 Bacille Calmette-Guérin (BCG) Wiki 0.32
    drug2490 Placebo Wiki 0.29

    Correlated MeSH Terms (5)


    Name (Synonyms) Correlation
    D011014 Pneumonia NIH 0.32
    D012141 Respiratory Tract Infections NIH 0.22
    D000257 Adenoviridae Infections NIH 0.20
    Name (Synonyms) Correlation
    D003141 Communicable Diseases NIH 0.18
    D007239 Infection NIH 0.11

    Correlated HPO Terms (2)


    Name (Synonyms) Correlation
    HP:0002090 Pneumonia HPO 0.32
    HP:0011947 Respiratory tract infection HPO 0.22

    Clinical Trials

    Navigate: Correlations   HPO

    There are 5 clinical trials


    1 A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study in Adults to Determine the Safety, Efficacy, and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19

    The aim of the study is to assess the safety, efficacy, and immunogenicity of AZD1222 for the prevention of COVID-19.

    NCT04516746
    Conditions
    1. COVID-19
    2. SARS-CoV-2
    Interventions
    1. Biological: AZD1222
    2. Biological: Placebo

    Primary Outcomes

    Description: A binary response, whereby a participant is defined as a COVID-19 case if their first case of SARS-CoV-2 RT-PCR-positive symptomatic illness occurs ≥ 15 days post second dose of study intervention. Otherwise, a participant is not defined as a COVID-19 case.

    Measure: The efficacy of 2 IM doses of AZD1222 compared to placebo for the prevention of COVID-19 in adults ≥ 18 years of age

    Time: 1 year

    Description: Incidence of adverse events. Incidence of serious adverse events, medically attended adverse events, and adverse events of special interest.

    Measure: The safety and tolerability of 2 IM doses of AZD1222 compared to placebo in adults ≥ 18 years of age

    Time: a: 28 days post each dose of study Intervention. / b: from Day 1 post-treatment through Day 730.

    Description: Incidence of local and systemic solicited adverse events.

    Measure: The reactogenicity of 2 IM doses of AZD1222 compared to placebo in adults ≥ 18 years of age (Substudy only)

    Time: 7 days post each dose of study intervention.

    Secondary Outcomes

    Description: The proportion of participants who have a post-treatment response (negative at baseline to positive post treatment with study intervention) for SARS-CoV-2 Nucleocapsid antibodies over time.

    Measure: The efficacy of 2 IM doses of AZD1222 compared to placebo for the prevention of SARS-CoV-2 infection

    Time: 1 year

    Description: The incidence of the first case of SARS-CoV-2 RT-PCR-positive symptomatic illness for a participant occurring at or after 15 days post second dose of study intervention using criteria from the CDC.

    Measure: The efficacy of 2 IM doses of AZD1222 compared to placebo for the prevention of symptomatic COVID-19 using CDC criteria

    Time: 1 year

    Description: The incidence of the first case of SARS-CoV-2 RT-PCR positive symptomatic illness occurring ≥ 15 days post second dose of study intervention using University of Oxford defined symptom criteria.

    Measure: The efficacy of 2 IM doses of AZD1222 compared to placebo for the prevention of University of Oxford defined symptomatic COVID-19

    Time: 1 year

    Description: The incidence of SARS-CoV-RT-PCR-positive severe or critical symptomatic illness occurring 15 days or more post second dose of study intervention.

    Measure: The efficacy of 2 IM doses of AZD12222 compared to placebo for the prevention of severe or critical symptomatic COVID-19.

    Time: 1 year

    Description: The incidence of COVID-19-related Emergency Department visits occurring ≥ 15 days post second dose of study intervention

    Measure: The efficacy of 2 IM doses of AZD1222 compared to placebo for the prevention of COVID-19-related Emergency Department visits

    Time: 1 year

    Description: Post-treatment GMTs and GMFRs in SARS-CoV-2 S, RBD antibodies (MSD serology assay); The proportion of participants who have a post-treatment seroresponse (≥ 4-fold rise in titers) to the S, RBD antigens of AZD1222 (MSD serology assay)

    Measure: Antibody responses to AZD1222 S antigen following 2 IM doses of AZD1222 or placebo (Substudy and Illness Visits only)

    Time: 28 days post each dose

    Description: Post-treatment GMTs and GMFRs in SARS-CoV-2 neutralizing antibodies (wild-type assay or pseudo-neutralization assay); Proportion of participants who have a post-treatment seroresponse (≥ 4-fold rise in titers) to AZD1222 as measured by SARS-CoV-2 neutralizing antibodies (wild-type assay or pseudo-neutralization assay)

    Measure: Anti-SARS-CoV-2 neutralizing antibody levels in serum following 2 IM doses of AZD1222 or placebo (Sub-study and Illness Visits only)

    Time: 28 days post each dose
    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 Single-center, Randomized, Double-Blinded, Placebo-Controlled, Phase Ⅱ Clinical Trial of Recombinant COVID-19 Vaccine (Sf9 Cells), in the Subjects From Healthy Aged 18 Years and Above

    This is a phase Ⅱ, single-center, randomized, double-blind, placebo-controlled study, to evaluate the immunogenicity and safety of the recombinant COVID-19 vaccine (Sf9 cells) in the subjects from healthy adults and elderly adults aged 18 years and above (aged 18-60 and 60-85 years) with different immunization procedures (0, 21 days and 0, 14, 28 days) and doses (20μg/40μg).

    NCT04640402
    Conditions
    1. COVID-19
    Interventions
    1. Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen
    2. Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen
    3. Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen
    4. Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen
    5. Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen
    6. Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen
    7. Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen
    8. Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen
    9. Biological: Low-dose placebo (18-59 years) & Two dose regimen
    10. Biological: Low-dose placebo (18-59 years) & Three dose regimen
    11. Biological: High-dose placebo (18-59 years) & Two dose regimen
    12. Biological: High-dose placebo (18-59 years) & Three dose regimen
    13. Biological: Low-dose placebo (60-85 years) & Two dose regimen
    14. Biological: Low-dose placebo (60-85 years) & Three dose regimen
    15. Biological: High-dose placebo (60-85 years) & Two dose regimen
    16. Biological: High-dose placebo (60-85 years) & Three dose regimen

    Primary Outcomes

    Description: Geometric mean (GMT) of specific antibody against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Spike protein Receptor-binding domain(S-RBD) protein (ELISA)

    Measure: Geometric mean (GMT) of specific antibody

    Time: 1 months after immunization in each study group

    Description: The incidence of adverse reaction (AR)

    Measure: The incidence of adverse reaction (AR)

    Time: 0 to 7 days after vaccination in each study group

    Secondary Outcomes

    Description: The incidence of adverse events (AE)

    Measure: The incidence of adverse events (AE)

    Time: 0 to 28 days after vaccination in each study group

    Description: The incidence of severe adverse events (SAE)

    Measure: The incidence of severe adverse events (SAE)

    Time: 0 to 28 days after vaccination in each study group

    Description: The incidence of serious adverse events

    Measure: The incidence of serious adverse events

    Time: 6 months after vaccination in each study group

    Description: Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies (euvirus and pseudovirus-neutralizing assays)

    Measure: Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies

    Time: 1 months after immunization in each study group

    Description: The positive conversion rate of S-RBD protein-specific antibody (ELISA) against SARS-CoV-2

    Measure: The positive conversion rate of S-RBD protein-specific antibody

    Time: 14 days, 30 days after immunization in each study group

    Description: Geometric mean fold increase (GMI) of S-RBD protein-specific antibody (ELISA) against SARS-CoV-2

    Measure: Geometric mean fold increase (GMI) of S-RBD protein-specific antibody

    Time: 14 days, 30 days after immunization in each study group

    Description: Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies (euvirus and pseudovirus-neutralizing assays)

    Measure: Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies

    Time: 14 days after immunization in each study group

    Description: The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody (euvirus and pseudovirus neutralization test)

    Measure: The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody

    Time: 14 days, 30 days after immunization in each study group

    Description: Geometric mean fold increase (GMI) of anti-SARS-CoV-2 specific neutralizing antibodies (eucivirus and pseudovirus neutralization assays)

    Measure: Geometric mean fold increase (GMI) of anti-SARS-CoV-2 specific neutralizing antibodies

    Time: 14 days, 30 days after immunization in each study group

    Other Outcomes

    Description: The consistency analysis of the specific antibody (ELISA) and the specific neutralizing antibody (euvirus and pseudovirus neutralization assays) against SARS-CoV-2 S-RBD protein

    Measure: The consistency analysis of the specific antibody and the specific neutralizing antibody

    Time: 1 months after immunization in each study group

    Description: The geometric mean titer (GMT) ratio of the SARS-CoV-2 neutralizing antibody and the S-RBD protein specific antibody in each study groups

    Measure: The geometric mean titer (GMT) ratio of the SARS-CoV-2 neutralizing antibody and the S-RBD protein specific antibody

    Time: 1 months after immunization in each study group

    Description: The persistence (GMT,GMI,positive conversion rate) of specific antibodies against SARS-CoV-2 S-RBD protein

    Measure: The persistence (GMT,GMI,positive conversion rate) of specific antibodies

    Time: 6 months after vaccination in each study group

    Description: Subtypes of IgG antibodies against the S-RBD protein of SARS-CoV-2 after immunization in each study group

    Measure: Subtypes of immunoglobulin G (IgG) antibodies

    Time: 1 months after immunization in each study group
    5 A Phase I/II Randomized, Double-blind, Placebo-controlled Multicentre Study in Participants Aged 18 Years or Older to Determine the Safety and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19

    The COVID-19 pandemic has caused major disruption to healthcare systems with significant socioeconomic impacts. Currently, there are no licensed preventions available against COVID-19 and accelerated vaccine development is urgently needed. A safe and effective vaccine for COVID 19 prevention would have significant global public health impact.

    NCT04568031
    Conditions
    1. COVID-19
    Interventions
    1. Drug: AZD1222
    2. Drug: 0.9% (w/v) saline

    Primary Outcomes

    Description: The primary immunogenicity endpoint is the proportion of participants who have a post treatment seroresponse (≥ 4-fold rise in titres from Day 1 baseline value) to the Spike antigens of AZD1222 (MSD serology assay) at Day 57 , and will be calculated along with its 95% CI based on the Clopper-Pearson method in each treatment groups in each cohort (C, and D) and also Subcohorts D1, and D2 separately.

    Measure: Proportion of participants who have a post treatment seroresponse to the spike antigens of AZD1222

    Time: Day 57

    Description: The incidence of local and systemic solicited reactogenicity signs and symptoms for 7 days following throughout vaccination (Day 1 to 8).

    Measure: The incidence of local and systemic solicited reactogenicity signs and symptoms for 7 days following throughout vaccination

    Time: Day 1 to 8

    Description: The incidence of local and systemic solicited reactogenicity signs and symptoms for 7 days following throughout vaccination (Day 29 to 36).

    Measure: The incidence of local and systemic solicited reactogenicity signs and symptoms for 7 days following throughout vaccination

    Time: Day 29 to 36

    Description: The incidence of AEs, serious adverse events (SAEs) and adverse events of special interest (AESIs) collected from Day 1 through Day 57.

    Measure: The incidence of AEs, serious adverse events (SAEs) and adverse events of special interest (AESIs)

    Time: Day 1 through Day 57

    Description: The change from baseline for blood chemistry measures (Creatinine in U/L ,Bilirubin in mg/dL, ALP in U/L, AST in U/L, ALT in U/L, Albumin in g/dL, Potassium in mEq/L, Calcium in mg/dL Sodium mEq/L, Creatine Kinase in U/L)

    Measure: Biochemistry; change from baseline for blood chemistry measures

    Time: Day 8, Day 29, Day 36, and Day 57

    Description: The change from baseline for hematology measures (Hb in g/dL, Leukocyte in /uL, Leukocyte differential count in /uL and Platelet count in /uL)

    Measure: Haematology; change from baseline for hematology/hemostasis measures

    Time: Day 8, Day 29, Day 36, and Day 57

    Secondary Outcomes

    Description: The proportion of participants who have a post treatment seroresponse (≥ 4-fold rise in titres from Day 1 baseline value) to RBD antigens of AZD1222 (MSD serology assay) at Day 57, and will be calculated along with its 95% CI based on the Clopper-Pearson method in each treatment groups in each cohort (C, and D) and also Subcohorts D1, and D2 separately.

    Measure: Proportion of participants who have a post treatment

    Time: Day 57

    Description: Geometric mean titres and geometric mean fold rise [Time Frame: Day 57 ] Geometric mean titres (GMT) and geometric mean fold rise (GMFR) of immunogenicity to Spike and RBD antigen of AZD1222 (MSD serology assay) with its 95% CI will be computed at each time point in each treatment arm in each cohort (C, and D) and also in Subcohorts D1, and D2 separately.

    Measure: Genometric mean titres and genometric mean fold rise

    Time: Day 57

    Description: The proportion of participants who have a post treatment seroresponse to AZD1222 as measured by SARS-CoV-2 nAbs [Time Frame: Day 57 ] The proportion of participants who have a post treatment seroresponse (≥ 4-fold rise in titres from Day 1 baseline value) to AZD1222 as measured by SARS-CoV02 nAbs (wild-type assay or pseudoneutralisation assay) at Day 57, and will be calculated along with its 95% CI based on the Clopper-Pearson method in each treatment groups in each cohort (C, and D) and also Subcohorts D1, and D2 separately.

    Measure: Proportion of participants who have a post treatment seroresponse to AZD1222 as measured by SARS-CoV-2 nAbs

    Time: Day 57

    Description: The incidence of serious adverse events (SAEs) and adverse events of special interest (AESIs) collected from Day 1 through Day 365.

    Measure: The incidence of serious adverse events (SAEs) and adverse events of specisl interest (AESIs) collected from Day1 through Day365

    Time: Day 1 through Day 365

    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