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NCT01386489 · ClinicalTrials.gov registry record · Phase 1
Immune Responses to Two Experimental HIV Vaccines in Healthy Adults
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT01386489: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01386489 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01386489, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
Background: The primary focus of the Vaccine Research Center (VRC) at the NIH is to develop vaccines for HIV/AIDS. The main purpose of this study is to look in detail at the body s immune response to two experimental HIV vaccines currently in development at the VRC. One is known as the rAd5 vaccine and the other is known as the DNA vaccine. These vaccines are made with pieces of manufactured DNA. They do not contain live or killed HIV. It is impossible for study vaccines to give you HIV and they cannot cause you to give HIV to someone else. Both of these experimental vaccines have been given to people before in other research studies. They have not been approved for treating or preventing HIV infection. Purpose: The main purpose of this study is to look in detail at the body s immune responses after the experimental HIV vaccines are given and to assess safety of the study vaccines. Eligibility: Healthy volunteers between the ages of 18 and 50 who are not infected with HIV and who meet the eligibility requirements. Design: Participants will be screened with a medical history (including questions about sexual history and drug use), physical exam, and blood tests. The study will have two groups: \<TAB\>One group will receive one injection of the rAd5 vaccine, and have 8 clinic visits over 3 months. \<TAB\>The second group will have three injections of the DNA vaccine, one injection of the rAd5 vaccine, and have 12 clinic visits over 6 months. All participants will be asked to provide blood and body fluid samples for testing during the study. Payment for participation will be provided....
Interventions
- BIOLOGICAL VRC-HIVADV014-00-VP
- BIOLOGICAL VRC-HIVDNA016-00-VP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2011-06-17 |
| Est. Completion | 2014-03-19 |
| Phase | Phase 1 |
What the finished NCT01386489 record still lists
NCT01386489 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which VRC-HIVADV014-00-VP is the first listed.
NCT01386489 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01386489 about?
NCT01386489 is a clinical study titled "Immune Responses to Two Experimental HIV Vaccines in Healthy Adults". Background: The primary focus of the Vaccine Research Center (VRC) at the NIH is to develop vaccines for HIV/AIDS. The main purpose of this study is to look in detail at the body s immune response to two experimental HIV vaccines currently in development at the VRC. One is known as the rAd5 vaccine...
What is the current status of trial NCT01386489?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2011-06-17. Estimated completion is 2014-03-19.
What interventions are being tested in trial NCT01386489?
The interventions under investigation include: VRC-HIVADV014-00-VP (BIOLOGICAL), VRC-HIVDNA016-00-VP (BIOLOGICAL).
Who is sponsoring clinical trial NCT01386489?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01386489's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 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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