Comparison · NCT00865566-sae
Vaccine vs Placebo: serious adverse events
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. Vaccine vs Placebo: serious adverse events. Trial comparisons, record NCT00865566-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00865566-sae
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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 | 0.0615 | 0.0494 | 0.0761 | wilson | |
| Risk in group 2 | 0.0759 | 0.0625 | 0.092 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0145 | -0.0345 | 0.0054 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.809 | 0.605 | 1.08 | log | |
| Odds ratio, group 1 over group 2 | 0.797 | 0.584 | 1.09 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Vaccine than on Placebo | 69 | 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 | Vaccine | Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.~DNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid~Recombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10\^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid | 77 | 1,253 | EG000 |
| Group 2 | Placebo | Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.~DNA vaccine placebo: 1 mL IM via Biojector® in either deltoid~HIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid | 95 | 1,251 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Reporting of all AEs occurred during 2 periods for each participant: 1) from enrollment through 28 days after the third vaccination, and 2) from the fourth vaccination through 28 days after the fourth vaccination. Between and after these time periods, only SAEs, new chronic conditions requiring medical intervention of more than 30 days, and newly diagnosed/treated STIs were reported. Events requiring expedited reporting (protocol section 12.3) were reported through the study, up to 60 months.
Source ClinicalTrials.gov
Trial
- Title
Safety and Effectiveness of HIV-1 DNA Plasmid Vaccine and HIV-1 Recombinant Adenoviral Vector Vaccine in HIV-Uninfected, Circumcised Men and Male-to-Female (MTF) Transgender Persons Who Have Sex With Men
- NCT number
- NCT00865566
- Phases
- PHASE2
- Conditions
- HIV Infections
- Interventions
- DNA plasmid vaccine, Recombinant adenoviral serotype 5 (rAD5) vector vaccine, DNA vaccine placebo, HIV-1 recombinant adenovirus vaccine placebo
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Results first posted
- 2019-02-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00865566?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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