Candidate HIV Vaccine
Public ClinicalTrials.gov record NCT00089531. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of a 6-Plasmid Multiclade HIV-1 DNA Vaccine, VRC-HIVDNA016-00-VP, in Uninfected Adult Volunteers
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 participation in the study.
Study identification
- NCT ID
- NCT00089531
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 15 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 44 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 1, 2004
- Primary completion
- Not listed
- Completion
- Jan 14, 2008
- Last update posted
- Jul 1, 2017
2004 – 2008
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00089531, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 1, 2017 · Synced Sep 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00089531 live on ClinicalTrials.gov.