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NCT00108654 · ClinicalTrials.gov registry record · Phase 1
Vaccine Treatment for HIV-Infection
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT00108654: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00108654 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00108654, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
This study will determine the safety and side effects of an experimental adenoviral vector vaccine given to patients who previously received a different HIV vaccine (VRC-HIVDNA016-00-VP) in a prior NIAID study. The study will also monitor participants for the social impact of being in an HIV vaccine study (e.g., problems with insurance, health care, friends, family, employment, housing, and so forth). The study vaccine is made using an adenovirus (a common virus that causes upper respiratory infections, such as the common cold, eye infection, urine infection or diarrhea) that has been modified to contain DNA that codes for three HIV proteins. The modified virus cannot reproduce in the body and cannot cause HIV disease or adenoviral infections. Healthy volunteers who previously received three injections of the VRC-HIVDNA016-00-VP under the NIAID study VRC 007 (protocol 04-I-0254) may be eligible for this study. Participants receive one injection of the adenoviral vector vaccine. It is given the day they enroll in the study, as a single injection in an upper arm muscle. Also on that day they have a brief physical examination, medical history, blood and urine tests, pregnancy test for women, and counseling, as needed, about HIV and pregnancy avoidance. Subjects are observed for side effects for at least 30 minutes after the vaccination and are required to telephone the clinic staff 1 to 2 days after the injection for follow-up. In addition, they are given a diary card to take home, on which they record their temperature and any symptoms daily for 5 days. Subjects return to the clinic for 5 follow-up visits at weeks 2, 4, 6, 12 and 24 after the injection. At each visit they are checked for health changes or problems since the last visit, asked how they are feeling and what medications they are taking. They have blood drawn at every visit and urine samples collected at most visits. They are tested for HIV three or more times and are questioned about their sexual behav
Interventions
- DRUG VRC-HIVADV014-00-VP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2005-04-13 |
| Est. Completion | 2008-01-15 |
| Phase | Phase 1 |
What the finished NCT00108654 record still lists
NCT00108654 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which VRC-HIVADV014-00-VP is the first listed.
NCT00108654 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00108654 about?
NCT00108654 is a clinical study titled "Vaccine Treatment for HIV-Infection". This study will determine the safety and side effects of an experimental adenoviral vector vaccine given to patients who previously received a different HIV vaccine (VRC-HIVDNA016-00-VP) in a prior NIAID study. The study will also monitor participants for the social impact of being in an HIV vaccine...
What is the current status of trial NCT00108654?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2005-04-13. Estimated completion is 2008-01-15.
What interventions are being tested in trial NCT00108654?
The interventions under investigation include: VRC-HIVADV014-00-VP (DRUG).
Who is sponsoring clinical trial NCT00108654?
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 NCT00108654's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 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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