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NCT00801697 · ClinicalTrials.gov registry record · Phase 1

Safety and Immune Response to Preventive HIV Immunization With Adenovirus Serotype 5 or 35 Vector

A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
192
Enrollment target

NCT00801697: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00801697 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 192 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (220% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00801697, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
192 participants
Enrollment target

Study Summary

This study will evaluate the safety and preliminary immune response to recombinant adenoviral serotype 35 and 5 HIV-1 vaccines in HIV-uninfected adults.

Interventions

  • BIOLOGICAL DNA Vaccine
  • BIOLOGICAL DNA Vaccine placebo
  • BIOLOGICAL rAd35
  • BIOLOGICAL rAd35 placebo
  • BIOLOGICAL rAd5

Trial Details

FieldValue
Enrollment Target 192 participants
Start Date 2009-02
Est. Completion 2015-04
Phase Phase 1

What the finished NCT00801697 record still lists

NCT00801697 is an interventional study that assigns participants to a tested intervention. The registered 192 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 (220% higher).

The record links to 0 conditions, and to 5 interventions - of which DNA Vaccine is the first listed.

NCT00801697 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00801697 about?

NCT00801697 is a clinical study titled "Safety and Immune Response to Preventive HIV Immunization With Adenovirus Serotype 5 or 35 Vector". This study will evaluate the safety and preliminary immune response to recombinant adenoviral serotype 35 and 5 HIV-1 vaccines in HIV-uninfected adults.

What is the current status of trial NCT00801697?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 192 participants. The study started on 2009-02. Estimated completion is 2015-04.

What interventions are being tested in trial NCT00801697?

The interventions under investigation include: DNA Vaccine (BIOLOGICAL), DNA Vaccine placebo (BIOLOGICAL), rAd35 (BIOLOGICAL), rAd35 placebo (BIOLOGICAL), rAd5 (BIOLOGICAL).

Who is sponsoring clinical trial NCT00801697?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00801697's enrollment target sits among peer trials

192 282nd of 2000 higher than 1,718 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 NCT00801697, the US trial registry maintained by the National Library of Medicine. NCT00801697 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.