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Comparison · NCT00865566-684e4785

Vaccine vs Placebo: HIV-1 Infections Diagnosed After Day 0 Including All Available Follow-up Through the Maximum Month 48 Visit

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: HIV-1 Infections Diagnosed After Day 0 Including All Available Follow-up Through the Maximum Month 48 Visit. Trial comparisons, record NCT00865566-684e4785. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00865566-684e4785

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.060.04810.0745wilson
Risk in group 20.05460.04330.0687wilson
Risk difference, group 1 minus group 20.00533-0.0130.0238newcombe hybrid score
Risk ratio, group 1 over group 21.10.7981.51log
Odds ratio, group 1 over group 21.10.7871.55log
Number needed to treat, for one more participant with the outcome on Vaccine than on Placebo187from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Vaccine
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
751,251OG000
Group 2Placebo
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
681,245OG001

Outcome

Type
PRIMARY
Title
HIV-1 Infections Diagnosed After Day 0 Including All Available Follow-up Through the Maximum Month 48 Visit
Description
For time-to-event analysis, an event is defined as HIV-1 infection and participants are censored if they dropped out early or completed the trial. HIV-1 diagnosis date is defined as the date of the earliest specimen collection yielding a positive HIV test. Participants remaining uninfected were censored at the latest specimen collection with a negative HIV-1 test.
Time frame
Enrollment through Month 48 visit
Population
Modified Intent-to-Treat Cohort

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

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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