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NCT01438606 · ClinicalTrials.gov registry record · Phase 1

Evaluating the Safety of and Immune Response to the VSV-Indiana HIV Vaccine in Healthy, HIV-Uninfected Adults

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

Completed
Registry status
Phase 1
Development phase
60
Enrollment target

NCT01438606: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT01438606 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01438606, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
60 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the safety and immune response to an HIV vaccine in HIV-uninfected adults. Study researchers will also determine the maximum dose of the vaccine that participants can safely receive.

Primary Outcome

Pain, tenderness, erythema, induration, and maximum severity of pain and/or tenderness; frequency and severity of systemic reactogenicity signs and symptoms: fever, malaise/fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and maximum severity of systemic symptoms

Interventions

  • BIOLOGICAL VSV-Indiana HIV gag vaccine
  • BIOLOGICAL Placebo injection (normal saline)

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2011-10
Phase Phase 1

What the finished NCT01438606 record still lists

NCT01438606 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

The record links to 0 conditions, and to 2 interventions - of which VSV-Indiana HIV gag vaccine is the first listed.

NCT01438606 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01438606 about?

NCT01438606 is a clinical study titled "Evaluating the Safety of and Immune Response to the VSV-Indiana HIV Vaccine in Healthy, HIV-Uninfected Adults". The purpose of this study is to evaluate the safety and immune response to an HIV vaccine in HIV-uninfected adults. Study researchers will also determine the maximum dose of the vaccine that participants can safely receive.

What is the current status of trial NCT01438606?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2011-10.

What interventions are being tested in trial NCT01438606?

The interventions under investigation include: VSV-Indiana HIV gag vaccine (BIOLOGICAL), Placebo injection (normal saline) (BIOLOGICAL).

Who is sponsoring clinical trial NCT01438606?

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 NCT01438606's enrollment target sits among peer trials

60 831st of 2000 higher than 1,106 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 NCT01438606, the US trial registry maintained by the National Library of Medicine. NCT01438606 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.