Part A (Open-label): Analysis Group 1 (AG1) + Analysis Group 3 (AG3) vs Part A (Open-label): Analysis Group 2-1 (AG2-1) + Analysis Group 4-1 (AG4-1): Part A: Number of Participants With First COVE-based Severe COVID-19 Occurrence From 1 Day After Month 0 Dose to Month 6 Dose in FAS Cohort, Comparing Baseline SARS-CoV-2 Negative vs Positive, Regardless of HI
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.00244 | 0.00118 | 0.00503 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.000624 | 0.000286 | 0.00136 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.00182 | 0.000359 | 0.00443 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 3.91 | 1.32 | 11.6 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 3.92 | 1.32 | 11.7 | log | ClinicalTrials.gov | |
Number needed to treat, for one more participant with the outcome on Part A (Open-label): Analysis Group 1 (AG1) + Analysis Group 3 (AG3) than on Part A (Open-label): Analysis Group 2-1 (AG2-1) + Analysis Group 4-1 (AG4-1) | 550 | 226 | 2,780 | from the risk difference interval | ClinicalTrials.gov |
Groups 2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | Part A (Open-label): Analysis Group 1 (AG1) + Analysis Group 3 (AG3) | Participants who are overall SARS-CoV-2 negative at baseline regardless of HIV status | 7 | 2,867 | OG000 | ClinicalTrials.gov |
| Group 2 | Part A (Open-label): Analysis Group 2-1 (AG2-1) + Analysis Group 4-1 (AG4-1) | Participants who are overall SARS-CoV-2 positive at baseline regardless of HIV status | 6 | 9,613 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Part A: Number of Participants With First COVE-based Severe COVID-19 Occurrence From 1 Day After Month 0 Dose to Month 6 Dose in FAS Cohort, Comparing Baseline SARS-CoV-2 Negative vs Positive, Regardless of HI | ClinicalTrials.gov |
| Description | The COVE-based severe COVID-19 endpoint is defined as the first occurrence of a confirmed case of COVE-based COVID-19, plus any of the following: 1. Clinical signs indicative of severe systemic illness, Respiratory Rate ≥ 30 per minute, Heart Rate ≥ 125 beats per minute, SpO2 ≤ 93% on room air at sea level or PaO2/FIO2 less than 300 mm Hg, OR 2. Respiratory failure or Acute Respiratory Distress Syndrome (ARDS), (defined as needing high-flow oxygen, noninvasive or mechanical ventilation, or ECMO), evidence of shock (systolic blood pressure less than 90 mmHg, diastolic BP less than 60 mmHg or requiring vasopressors), OR 3. Significant acute renal, hepatic, or neurologic dysfunction, OR 4. Admission to an intensive care unit or death. The severe COVE criteria require adjudication. | ClinicalTrials.gov |
| Time frame | 1 day after Month 0 dose until Month 6 dose | ClinicalTrials.gov |
| Population | FAS. Participants who are baseline overall SARS-CoV-2 negative regardless of HIV status are comprised of Analysis Groups 1 and 3. Those who are baseline overall SARS-CoV-2 positive regardless of HIV status are comprised of Analysis Groups 2-1 and 4-1. Of note, overall SARS-CoV-2 status negative indicates all anti-Spike (anti-S), anti-Nucleocapsid (anti-N), and virus detection (NAAT) negative. Overall SARS-CoV-2 status positive indicates one of anti-S, anti-N, or NAAT positive. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Efficacy Study of COVID-19 mRNA Vaccine in Regions With SARS-CoV-2 Variants of Concern | ClinicalTrials.gov |
| NCT number | NCT05168813 | ClinicalTrials.gov |
| Phases | PHASE2, PHASE3 | ClinicalTrials.gov |
| Conditions | SARS-CoV-2 Infection, HIV Infections, COVID-19 | ClinicalTrials.gov |
| Interventions | Moderna mRNA-1273, Moderna mRNA-1273.222, Vaccine 3 Dose, Vaccine 2 Dose | ClinicalTrials.gov |
| Lead sponsor | COVID-19 Prevention Network | ClinicalTrials.gov |
| Results first posted | 2025-11-26 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT05168813?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| Tables read | outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.