Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3448 | SARS-CoV-2 vaccine formulation 1 with adjuvant 1 Wiki | 1.00 |
| drug3449 | SARS-CoV-2 vaccine formulation 1 with adjuvant 2 Wiki | 1.00 |
| drug3452 | SARS-CoV-2 vaccine formulation 2 without adjuvant Wiki | 1.00 |
| Name (Synonyms) | Correlation |
|---|
Navigate: Correlations HPO
There is one clinical trial.
The primary objectives of the study are: - To describe the neutralizing antibody profile at Day 1, Day 22, and Day 36 of each study intervention group. - To describe the safety profile of all participants in each age group and each study intervention group up to 12 months post-last injection. The secondary objectives of the study are: - To describe binding antibody profile at Day 1, Day 22, Day 36, Day 181 (Cohort 1) or Day 202 (Cohort 2), and Day 366 (Cohort 1) or Day 387 (Cohort 2) of each study intervention group. - To describe the neutralizing antibody profile at Day 181 (Cohort 1) or Day 202 (Cohort 2) and at Day 366 (Cohort 1) and Day 387 (Cohort 2) of each study intervention group. - To describe the occurrence of virologically-confirmed COVID-19-like illness and serologically-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. - To evaluate the correlation / association between antibody responses to SARS-CoV-2 Recombinant Protein and the risk of COVID-19-like illness and/or serologically-confirmed SARS-CoV-2 infection.
Description: Neutralizing antibody titer expressed as geometric mean titer.
Measure: Neutralizing Antibody Titer at Day 1 Time: Day 1Description: Neutralizing antibody titer expressed as geometric mean titer.
Measure: Neutralizing Antibody Titer at Day 22 Time: Day 22Description: Neutralizing antibody titer expressed as geometric mean titer.
Measure: Neutralizing Antibody Titer at Day 36 Time: Day 36Description: Fold rise in antibody neutralization titer post-vaccination relative to Day 1.
Measure: Fold-rise of Neutralizing Antibody Titer at Day 22 Time: Day 22Description: Fold rise in antibody neutralization titer post-vaccination relative to Day 1.
Measure: Fold-rise of Neutralizing Antibody Titer at Day 36 Time: Day 36Description: Rise in antibody neutralizing titer (post/pre) relative to Day 1.
Measure: 2-fold and 4-fold Rise in Neutralization Antibody titer at Day 22 Time: Day 22Description: Rise in antibody neutralizing titer (post/pre) relative to Day 1.
Measure: 2-fold and 4-fold Rise in Neutralization Antibody titer at Day 36 Time: Day 36Description: Percentage of participants with baseline values below lower limit of quantification (LLOQ) with detectable neutralization titer above assay LLOQ.
Measure: Percentage of Participants with Neutralizing Antibody Seroconversion at Day 22 Time: Day 22Description: Percentage of participants with baseline values below LLOQ with detectable neutralization titer above assay LLOQ.
Measure: Percentage of Participants with Neutralizing Antibody Seroconversion at Day 36 Time: Day 36Description: Immediate adverse events includes unsolicited systemic adverse events occuring within 30 minutes after vaccination.
Measure: Number of Participants with Immediate Adverse Events Time: Within 30 minutes after vaccinationDescription: Injection site reactions: injection site pain, erythema and swelling. Systemic reactions: fever, headache, malaise and myalgia.
Measure: Number of Participants With Solicited Injection Site or Systemic Reactions Time: Within 7 days after vaccinationDescription: Adverse events other than solicited reactions.
Measure: Number of Participants with Unsolicited Adverse Events Time: Within 21 days after vaccinationDescription: Medically attended adverse events are adverse events with a new onset or a worsening of a condition that prompts the participant to seek unplanned medical advice at a physician's office or Emergency Department.
Measure: Number of Participants with Medically Attended Adverse Events Time: From Day 1 up to the end of study (Day 366 for Cohort 1 and Day 387 for Cohort 2)Description: SAEs are collected throughout the study.
Measure: Number of Participants with Serious Adverse Events (SAEs) Time: From Day 1 up to the end of study (Day 366 for Cohort 1 and Day 387 for Cohort 2)Description: Adverse events of special interest pre-defined adverse event collected using the same process as for other adverse events.
Measure: Number of Participants with Adverse Events of Special Interest Time: From Day 1 up to the end of study (Day 366 for Cohort 1 and Day 387 for Cohort 2)Description: Antibody titers are expressed as geometric mean concentration.
Measure: Binding Antibody Concentration Time: Day 1, Day 22, Day 36, Day 181 (Cohort 1) or Day 202 (Cohort 2), and Day 366 (Cohort 1) or Day 387 (Cohort 2)Description: Fold rise in concentration relative to Day 1.
Measure: Binding Antibody Concentration Ratio Time: Day 22, Day 36, Day 181 (Cohort 1) or Day 202 (Cohort 2), and Day 366 (Cohort 1) or Day 387 (Cohort 2)Description: ≥ 2 and ≥ 4 fold rise in concentration post/pre-vaccination.
Measure: Fold Rise in Binding Antibody Concentration Time: Day 22, Day 36, Day 181 (Cohort 1) or Day 202 (Cohort 2), and Day 366 (Cohort 1) or Day 387 (Cohort 2)Description: Neutralizing antibody titer expressed as geometric mean titer.
Measure: Neutralizing Antibody Titer Time: Day 181 and Day 366 (Cohort 1) and Day 202 and Day 387 (Cohort 2)Description: Fold rise in antibody neutralization titer post-vaccination relative to Day 1.
Measure: Fold-rise in Neutralization Titer at Day 181 and Day 366 (Cohort 1) and Day 202 and Day 387 (Cohort 2) Time: Day 181 and Day 366 (Cohort 1) and Day 202 and Day 387 (Cohort 2)Description: Fold rise in antibody neutralization titer post-vaccination relative to Day 1.
Measure: 2-fold and 4-fold Rise in Neutralization Titer [Post/Pre] at Day 181 and 366 (Cohort 1) and Day 202 and Day 387 (Cohort 2) Time: Day 181 and Day 366 (Cohort 1) and Day 202 and Day 387 (Cohort 2)Description: Neutralizing antibody seroconversion is defined as values below LLOQ at baseline with detectable neutralization titer above assay LLOQ at Day 181 (Cohort 1) or Day 202 (Cohort 2) and at Day 366 (Cohort 1) or Day 387 (Cohort 2)
Measure: Percentage of Participants with Neutralizing Antibody Seroconversion at Day 181 and 366 (Cohort 1) and Day 202 and Day 387 (Cohort 2) Time: Day 181 and Day 366 (Cohort 1) and Day 202 and Day 387 (Cohort 2)Description: Virologically-confirmed COVID-19-like illness is defined by specified clinical symptoms and signs and confirmed by nucleic acid viral detection assay. Illness surveillance is performed by active surveillance from Day 1 to Day 181 in Cohort 1 and from Day 1 to Day 202 in Cohort 2, and by passive surveillance during the remainder of the study period.
Measure: Number of Participants with Virologically-confirmed COVID-19-like Illness Time: From Day 1 up to the end of study (Day 366 for Cohort 1 and Day 387 for Cohort 2)Description: Serologically-confirmed SARS-CoV-2 infection is defined by SARS-CoV-2-specific antibody detection. Illness surveillance is performed by active surveillance from Day 1 to Day 181 in Cohort 1 and from Day 1 to Day 202 in Cohort 2, and by passive surveillance during the remainder of the study period.
Measure: Number of Participants with Serologically-confirmed SARS-CoV-2 Infection Time: From Day 1 up to the end of study (Day 366 for Cohort 1 and Day 387 for Cohort 2)Description: Correlate of risk / protection is based on antibody responses to SARS-CoV-2, considering cases of virologically-confirmed COVID-19 and/or serologically confirmed SARS-CoV-2 infection.
Measure: Correlates of Risk / Protection Based on Antibody Responses to SARS-CoV-2 Time: From Day 1 up to the end of study (Day 366 for Cohort 1 and Day 387 for Cohort 2)Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
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