Last reviewed · How we verify
A Randomized Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP205 Delivered by Alternate Mucosal Routes in HIV-1 Uninfected Adult Volunteers
To compare the safety of ALVAC-HIV vCP205 to that of ALVAC-RG vCP65 rabies glycoprotein, delivered by a variety of mucosal routes. To evaluate the antibody, humoral, and cellular immune responses resulting from ALVAC-HIV vCP205. \[AS PER AMENDMENT 8/3/98: To obtain safety data on AIDSVAX B/B boosting administered by the intramuscular and intranasal routes in the context of previous immunization via alternate mucosal routes or intramuscularly with a canarypox vector expressing HIV-1 antigens (vCP205). To obtain immunogenicity data on AIDSVAX B/B boosting.\] One of the earliest observations in the HIV epidemic was the demonstration of HIV infection at mucosal surfaces of cells in the genital tract. These data suggest that priming of immune defenses of viral infected cells may be an important component in the strategy of developing an effective HIV vaccine. Direct immunization of relevant mucosal surfaces with a vectored vaccine may stimulate mucosal immunity. The ALVAC-HIV vCP205 immunogen is constructed from a live recombinant canarypox vector that has a good safety profile in volunteers and should allow mucosal induction of immunity.
Details
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 84 |
| Completion | 2000-10 |
Conditions
- HIV Infections
Interventions
- MN rgp120/HIV-1 and GNE8 rgp120/HIV-1
- ALVAC-HIV MN120TMG (vCP205)
- ALVAC-RG Rabies Glycoprotein (vCP65)
Primary outcomes
- To compare the safety of ALVAC-HIV vCP205 to that of ALVAC-RG vCP65 rabies glycoprotein, delivered by a variety of mucosal routes — Throughout study
- To evaluate the antibody, humoral, and cellular immune responses resulting from ALVAC-HIV vCP205 — Throughout study
- To obtain safety data on AIDSVAX B/B boosting administered by the intramuscular and intranasal routes in the context of previous immunization via alternate mucosal routes or intramuscularly with a canarypox vector expressing HIV-1 antigens (vCP205) — Throughout study
- To obtain immunogenicity data on AIDSVAX B/B boosting — Throughout study
Countries
United States