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NCT01215149 · ClinicalTrials.gov registry record · Phase 1

Safety and Immunogenicity Study of Ad26-ENVA and Ad35-ENV HIV Vaccines in Healthy HIV-uninfected Adults

A Phase 1 study, sponsored by International AIDS Vaccine Initiative.

Completed
Registry status
Phase 1
Development phase
218
Enrollment target

NCT01215149: Completed Phase 1 study, sponsored by International AIDS Vaccine Initiative.

NCT01215149 is a Phase 1 study that has completed, run by International AIDS Vaccine Initiative. The registered enrollment target is 218 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (263% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01215149, a Phase 1 study, has completed, sponsored by International AIDS Vaccine Initiative.

COMPLETED
Registry status
Phase 1
Development phase
218 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the safety and tolerability of Ad26.ENVA.01 and Ad35-ENV in low-risk for HIV-uninfected healthy adults administered in heterologous and homologous prime-boost regimens at different time intervals.

Primary Outcome

To evaluate the safety and tolerability of Ad26.ENVA.01 and Ad35-ENV administered in heterologous and homologous prime-boost regimens.

Interventions

  • BIOLOGICAL Placebo Control
  • BIOLOGICAL Ad35-ENV vaccine
  • BIOLOGICAL Ad26.ENVA.01 vaccine

Trial Details

FieldValue
Enrollment Target 218 participants
Start Date 2010-10
Est. Completion 2012-12
Phase Phase 1

What the finished NCT01215149 record still lists

NCT01215149 is an interventional study that assigns participants to a tested intervention. The registered 218 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (263% higher).

The record links to 0 conditions, and to 3 interventions - of which Placebo Control is the first listed.

NCT01215149 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01215149 about?

NCT01215149 is a clinical study titled "Safety and Immunogenicity Study of Ad26-ENVA and Ad35-ENV HIV Vaccines in Healthy HIV-uninfected Adults". The purpose of this study is to evaluate the safety and tolerability of Ad26.ENVA.01 and Ad35-ENV in low-risk for HIV-uninfected healthy adults administered in heterologous and homologous prime-boost regimens at different time intervals.

What is the current status of trial NCT01215149?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 218 participants. The study started on 2010-10. Estimated completion is 2012-12.

What interventions are being tested in trial NCT01215149?

The interventions under investigation include: Placebo Control (BIOLOGICAL), Ad35-ENV vaccine (BIOLOGICAL), Ad26.ENVA.01 vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT01215149?

This trial is sponsored by International AIDS Vaccine Initiative, which has 16 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01215149's enrollment target sits among peer trials

218 239th of 2000 higher than 1,761 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01215149, the US trial registry maintained by the National Library of Medicine. NCT01215149 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.