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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3103 | Serology for Covid-19 Wiki | 1.00 |
| drug2505 | Placebo Wiki | 0.05 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D018410 | Pneumonia, Bacterial NIH | 1.00 |
| D008173 | Lung Diseases, Obstructive NIH | 0.28 |
| D008171 | Lung Diseases, NIH | 0.22 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0006536 | Pulmonary obstruction HPO | 0.32 |
| HP:0002088 | Abnormal lung morphology HPO | 0.23 |
| HP:0002090 | Pneumonia HPO | 0.06 |
Navigate: Correlations HPO
There is one clinical trial.
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 approximately 2,664 healthy HIV-negative (HIV-) adult participants and in approximately 240 medically stable HIV-positive (HIV+) adult participants in up to 10 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.
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 386Description: 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 386Description: 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 daysDescription: 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 daysDescription: 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 daysDescription: 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 daysDescription: 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 35Description: 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 35Description: 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 35Description: 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 386Description: 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 386Description: 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 386Description: 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 vaccinationDescription: 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 vaccinationDescription: 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 vaccinationDescription: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen as detected by ELISA expressed as SPRs at Days 0 (baseline), 21 (post first dose), and at 3 and 6 months after the last vaccination in HIV- participants. SPR is defined as the proportion of participants with rises in ELISA units exceeding the 95th percentile of placebo participants who remain COVID-19 free by symptom monitoring.
Measure: Cohort 1: Serum IgG Antibody Levels at Multiple Time Points Expressed as Seroprotection Rates (SPRs) Time: Day 0 to 6 months after the last vaccinationDescription: 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 vaccinationDescription: 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 vaccinationDescription: 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 vaccinationDescription: 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 vaccinationDescription: 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 vaccinationDescription: 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 vaccinationDescription: 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 vaccinationDescription: 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 vaccinationDescription: 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 daysDescription: 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 vaccinationDescription: 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 vaccinationDescription: 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 vaccinationDescription: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen as detected by ELISA expressed as SPRs at Days 0 (baseline), 21 (post first dose), and at 3 and 6 months after the last vaccination in HIV+ participants. SPR is defined as the proportion of participants with rises in ELISA units exceeding the 95th percentile of placebo participants who remain COVID-19 free by symptom monitoring.
Measure: Cohort 2: Serum IgG Antibody Levels at Multiple Time Points Expressed as SPRs Time: Day 0 to 6 months after the last vaccinationDescription: 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 vaccinationDescription: 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 vaccinationDescription: 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 vaccinationDescription: 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 vaccinationDescription: 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 vaccinationDescription: 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 vaccinationDescription: 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 vaccinationDescription: 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 vaccinationDescription: 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 daysDescription: 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 385Description: 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 385Alphabetical 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