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NCT00083330 · ClinicalTrials.gov registry record · Phase 1
Safety and Immunogenicity of an HIV Vaccine in Normal Adult Volunteers
A Phase 1 study of Healthy and HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT00083330: Completed Phase 1 study of Healthy and HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00083330 is a Phase 1 study of Healthy and HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 36 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00083330, a Phase 1 study of Healthy and HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will test the safety of an experimental vaccine against HIV infection and see if it causes an immune response to HIV. The vaccine is given by injection (shot) in the upper arm. It is made from DNA that codes for three HIV proteins. The DNA is inserted into an adenovirus that carries it into the muscle cells. The adenovirus normally can cause eye or upper respiratory infections, such as a cold; however, for the vaccine, it has been modified so that it cannot cause illness. Nor can the vaccine cause HIV infection, because it codes for only three of the nine HIV proteins. Healthy, normal volunteers between 18 and 44 years of age who are not HIV-infected may be eligible for this study. Candidates are screened with a medical history and physical examination and blood and urine tests. Participants are randomly assigned to receive either the experimental vaccine or a placebo (an inactive substance that looks like the vaccine). The vaccine or placebo is administered to participants in groups, according to their entry into the study. The first group receives the lowest study dose of vaccine. If this dose is safe, then the second group receives a higher dose. If this dose is also safe, then the third and final group receives the highest study dose. Clinic staff observe the subjects for side effects for 30 minutes after the injection, and subjects keep a diary card for the next 5 days, recording their temperature and any symptoms that may appear. Subjects are contacted by a nurse 2 days after the injection for follow-up. Participants are seen at the clinic for follow-up visits 1, 2, 4, 12, and 24 weeks after the injection, and then are contacted by telephone for follow-up once a year until 5 years after the injection. The clinic visits include a physical examination, medical history, blood and urine tests, and HIV counseling, as needed. Women have pregnancy tests at the screening evaluation and again at study week 24. All subjects are tested for HIV at screening
Conditions Studied
Interventions
- DRUG VRC-HIVADV014-00-VP
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2004-05-18 |
| Est. Completion | 2009-10-01 |
| Phase | Phase 1 |
What the finished NCT00083330 record still lists
NCT00083330 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 647-participant average among 1,090 other Healthy trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which VRC-HIVADV014-00-VP is the first listed.
NCT00083330 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00083330 about?
NCT00083330 is a clinical study titled "Safety and Immunogenicity of an HIV Vaccine in Normal Adult Volunteers". This study will test the safety of an experimental vaccine against HIV infection and see if it causes an immune response to HIV. The vaccine is given by injection (shot) in the upper arm. It is made from DNA that codes for three HIV proteins. The DNA is inserted into an adenovirus that carries it in...
What is the current status of trial NCT00083330?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2004-05-18. Estimated completion is 2009-10-01.
What conditions does trial NCT00083330 study?
This clinical trial studies the following conditions: Healthy, HIV Infections.
What interventions are being tested in trial NCT00083330?
The interventions under investigation include: VRC-HIVADV014-00-VP (DRUG).
Who is sponsoring clinical trial NCT00083330?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00083330 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00083330's enrollment target sits among peer trials
36 595th of 1090 higher than 469 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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.
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