Comparison · NCT00865566-aa501b8e
Vaccine vs Placebo: Participant Dropout After Unblinding
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Vaccine vs Placebo: Participant Dropout After Unblinding. Trial comparisons, record NCT00865566-aa501b8e. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00865566-aa501b8e
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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 | 0.233 | 0.208 | 0.259 | wilson | |
| Risk in group 2 | 0.309 | 0.281 | 0.339 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0767 | -0.115 | -0.0381 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.752 | 0.651 | 0.869 | log | |
| Odds ratio, group 1 over group 2 | 0.677 | 0.556 | 0.824 | log | |
| Number needed to treat, for one fewer participant with the outcome on Vaccine than on Placebo | 13 | 8.69 | 26.3 | from the risk difference interval |
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 | 241 | 1,036 | OG000 |
| 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 | 309 | 999 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Participant Dropout After Unblinding
- Description
The trial was unblinded on April 23, 2013, and the protocol was in version 4 at the time.~For participants remaining uninfected, dropout is assessed only for primary follow-up, i.e. clinic visits. Protocol versions 4 and earlier included 24 months of primary follow-up, and versions 5 and later included 48 months. Participants may terminate early after completing primary follow-up, and participants who were found to be HIV-1 infected are analyzed as non-dropouts, so the number of dropouts and number of early terminations need not match.
- Time frame
- April 23, 2013 through trial closure (up to Month 48 visit)
- Population
- MITT population participants who were HIV-uninfected and on-study as of April 23, 2013
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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