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NCT00089531 · ClinicalTrials.gov registry record · Phase 1
Candidate HIV Vaccine
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT00089531 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 15 participants.
The verdict
NCT00089531, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
This study will evaluate whether an experimental vaccine intended to prevent HIV infection is safe and whether it causes any side effects. It will also examine whether the vaccine, called VRC-HIVDNA016-00-VP, causes an immune response, and will monitor participants for the social impact of being in an HIV vaccine study. VRC-HIVDNA016-00-VP contains synthetic DNA that codes for parts of four HIV proteins. It also contains a "promoter" piece of DNA that is needed to start protein production. The promoter DNA is also synthetic and is like the promoter in another virus called cytomegalovirus (CMV). The vaccine contains no live HIV virus or CMV and cannot cause either of these illnesses. Healthy volunteers between 18 and 44 years old who are HIV-negative may be eligible for this 32-week study. Candidates are screened with a medical history, physical examination, and blood and urine tests. Participants receive three injections of the experimental vaccine approximately 28 days apart. The injections are given with a system called the Biojector 2000 that delivers the vaccine through the skin into the muscle without the use of a needle. Subjects are observed for side effects for at least 30 minutes after each vaccination and are required to telephone the clinic staff 1 to 2 days after the injection to report how they are doing. In addition, they are given a diary card to take home, on which they record their temperature and any symptoms daily for five days. Participants return to the clinic two weeks after each injection. They return the completed diary card and are checked for any health changes or problems since the last visit. They are asked how they are feeling and what medications, if any, they have taken. Blood and urine samples are collected. Some subjects may be asked to have laboratory tests between regular visits if needed to evaluate a change in health. Participants are also asked about any social effects they may have experienced as a result of their participat
Interventions
- DRUG VRC-HIVDNA016-00-VP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2004-08-02 |
| Est. Completion | 2008-01-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00089531
The ClinicalTrials.gov registry entry for NCT00089531 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which VRC-HIVDNA016-00-VP is the first listed.
NCT00089531 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00089531 about?
NCT00089531 is a clinical study titled "Candidate HIV Vaccine". This study will evaluate whether an experimental vaccine intended to prevent HIV infection is safe and whether it causes any side effects. It will also examine whether the vaccine, called VRC-HIVDNA016-00-VP, causes an immune response, and will monitor participants for the social impact of being in ...
What is the current status of trial NCT00089531?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2004-08-02. Estimated completion is 2008-01-15.
What interventions are being tested in trial NCT00089531?
The interventions under investigation include: VRC-HIVDNA016-00-VP (DRUG).
Who is sponsoring clinical trial NCT00089531?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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