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NCT00009685 · ClinicalTrials.gov registry record · Phase 1
HIV-1 Vaccine Test in Uninfected Adult Volunteers
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT00009685 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 21 participants.
The verdict
NCT00009685, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
This study will test the safety of an experimental vaccine against HIV and will examine whether it causes an immune response to HIV virus proteins. A vaccine is given to try to create resistance or immunity to a disease or infection. The vaccine in this study is made from DNA (genetic material) of two HIV proteins called "gag" and "pol." Injected into a human, the viral DNA instructs the body to make small amounts of some HIV proteins. This study will see if the body then creates an immune response to these proteins. Study participants cannot catch HIV or AIDS from the DNA vaccine or proteins that may be made from it. Healthy normal volunteers between 18 and 60 years of age may be eligible for this study. Candidates will provide a medical history, including information on sexual activity and drug use. They will have a physical examination, blood tests, urine test and chest X-ray. All candidates enrolled in the study must use a barrier method of contraception for sexual intercourse from the start of the study until 3 months after the last vaccination. Participants will be assigned to one of two treatment groups: one will receive the experimental vaccine; the other will receive a control substance (inactive salt solution). The first five people assigned to the vaccine group will receive the lowest study dose of the vaccine. If this dose is safe, it will be increased three times for the next group of five and then eight times for the last group of five. Each group will have a total of seven people - five will receive the vaccine and two will get the salt solution. Before the first injection, and possibly the second and third, a catheter (thin plastic tube) will be placed into a vein so that treatment can be given quickly if there is a reaction to the vaccine. Participants will receive three injections in an upper arm muscle-one injection a month for three months-with a needle-less device called a Biojector. For each injection, the volunteer will * be observed for a
Interventions
- DRUG VRC4302
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2001-01 |
| Est. Completion | 2005-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00009685
The ClinicalTrials.gov registry entry for NCT00009685 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 21 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 VRC4302 is the first listed.
NCT00009685 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00009685 about?
NCT00009685 is a clinical study titled "HIV-1 Vaccine Test in Uninfected Adult Volunteers". This study will test the safety of an experimental vaccine against HIV and will examine whether it causes an immune response to HIV virus proteins. A vaccine is given to try to create resistance or immunity to a disease or infection. The vaccine in this study is made from DNA (genetic material) of t...
What is the current status of trial NCT00009685?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2001-01. Estimated completion is 2005-03.
What interventions are being tested in trial NCT00009685?
The interventions under investigation include: VRC4302 (DRUG).
Who is sponsoring clinical trial NCT00009685?
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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