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HIV Candidate Vaccine, ALVAC-HIV-1, Administration in HIV-Negative Adults

A Phase I Study of Aventis Pasteur Live Recombinant ALVAC-HIV (vCP205, HIV-1 Env/Gag/Pol) in Seronegative Adults Administered (1) Subcutaneously Via Ex Vivo Transfected, Autologous Dendritic Cells, (2) Intradermally, or (3) Intramuscularly

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00013572
Enrollment
36
Registered
2001-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, HIV Seronegativity

Keywords

Injections, Intramuscular, Injections, Intradermal, Injections, Subcutaneous, HIV-1, AIDS Vaccines, Dendritic Cells, HIV Seronegativity, Genes, env, Genes, pol, Genes, gag, Transfection, HIV Preventive Vaccine

Brief summary

The purpose of this study is to determine the best way to administer the candidate HIV vaccine, ALVAC HIV-1 (vCP205).

Detailed description

Healthy adult volunteers are assigned randomly to either a vaccine or placebo group. Injections are received either intramuscularly, intradermally, or by delivery under the skin of the volunteer's own white blood cells which have had dendritic cell reinfusion. Volunteers are vaccinated at 0, 1, 3, and 6 month time points. Volunteers are closely monitored for 1 hour after vaccination and keep a diary of symptoms for 1 week post-immunization. Volunteers undergo leukopheresis at the start of the study and after the last vaccination at Walter Reed Army Medical Center. Volunteers receive compensation benefits.

Interventions

Sponsors

Walter Reed Army Institute of Research (WRAIR)
Lead SponsorFED

Study design

Primary purpose
PREVENTION

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

Volunteers may be eligible for this study if they: * Are legal US residents. * Are healthy adults from 18 to 55 years of age.

Exclusion criteria

Volunteers will not be eligible for this study if they: * Are HIV-positive. * Are at highest risk for HIV infection. * Are pregnant or breast-feeding. * Are allergic to eggs or neomycin. * Use certain prescription medications.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026