Comparison · NCT03964415-8c897a4e
Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 vs Group 2: Placebo: Number of Participants With Adverse Events of Special Interest (AESIs)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 vs Group 2: Placebo: Number of Participants With Adverse Events of Special Interest (AESIs). Trial comparisons, record NCT03964415-8c897a4e. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03964415-8c897a4e
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.00206 | 0.000801 | 0.00528 | wilson | |
| Risk in group 2 | 0.00103 | 0.000282 | 0.00374 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00103 | -0.00196 | 0.00434 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2 | 0.367 | 10.9 | log | |
| Odds ratio, group 1 over group 2 | 2.01 | 0.367 | 11 | log | |
| Number needed to treat, for one more participant with the outcome on Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 than on Group 2: Placebo | 970 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Participants received adenovirus serotype 26.Mosaic 4.human immunodeficiency virus (Ad26.Mos4.HIV) 5\*10\^10 viral particles (vp) intramuscular (IM) injection into the deltoid muscle as a monotherapy at Months 0 (Day 1) and 3 (Day 84) (preferably the deltoid of the non-dominant upper arm) along with adjuvanted protein formulation consisting of Clade C protein 80 micrograms (mcg), Mosaic protein 75 mcg and adjuvanted aluminum phosphate 425 mcg, into the deltoid muscle at Months 6 (Day 168) and 12 (Day 364) (different deltoid for each injection). | 4 | 1,942 | OG000 |
| Group 2 | Group 2: Placebo | Participants received placebo into the deltoid muscle at Months 0 (Day 1), 3 (Day 84; 1 injection), 6 (Day 168) and 12 (Day 364; 2 injections). | 2 | 1,945 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Adverse Events of Special Interest (AESIs)
- Description
Number of participants with AESIs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Thrombotic events and/or thrombocytopenia (defined as platelet count below the lower limit of normal \[LLN\] range for the testing lab) were considered to be potential AESIs.
- Time frame
- Up to 6 months after the last vaccination (up to Month 18)
- Population
- The FAS set included all randomized participants who received at least one vaccine administration.
Source ClinicalTrials.gov
Trial
- Title
A Study of Heterologous Vaccine Regimen of Adenovirus Serotype 26 Mosaic4 Human Immunodeficiency Virus(Ad26.Mos4.HIV), Adjuvanted Clade C gp140 and Mosaic gp140 to Prevent HIV-1 Infection Among Cis-gender Men and Transgender Individuals Who Have Sex With Cis-gender Men and/or Transgender Individuals
- NCT number
- NCT03964415
- Phases
- PHASE3
- Conditions
- Healthy
- Interventions
- Ad26.Mos4.HIV, Clade C and Mosaic gp140 HIV bivalent vaccine, Placebo
- Lead sponsor
- Janssen Vaccines & Prevention B.V.
- Results first posted
- 2024-07-31
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03964415?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- 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
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone 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.
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