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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

Phase 1
Completed
Conditions
HIV Infections
Interventions
Biological: MN rgp120/HIV-1 and GNE8 rgp120/HIV-1
Biological: ALVAC-HIV MN120TMG (vCP205)
Biological: ALVAC-RG Rabies Glycoprotein (vCP65)
Registration Number
NCT00000884
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Brief Summary

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.

Detailed Description

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.

This randomized, double-blind trial evaluates the safety of and immune response to vaccination with ALVAC-HIV vCP205 given at 0, 1, 3, and 6 months. Patients are randomly assigned to 1 of 7 drug administration routes as follows:

Group A: Intramuscular Group B: Oral Group C: Intranasal Group D: Intrarectal Group E: Intravaginal Group F: Intranasal/intramuscular Group G: Intrarectal/intramuscular Twelve patients are randomized to each group, 8 of whom receive experimental therapy with ALVAC-HIV vCP205 and 4 of whom receive control therapy with ALVAC-RG vCP2058 (rabies vaccine). Women are preferentially enrolled, with a goal of 60% women (minimum of 4 women per treatment arm); only women are randomized to Group E. Blinding is maintained with respect to drug assignment rather than route of administration, after randomization. NOTE: The protocol will be amended to add 2 boost vaccinations with subunit products at approximately Months 9 and 12 when a suitable boost product is identified. \[AS PER AMENDMENT 8/3/98: The protocol has been modified to include 2 booster vaccinations to be administered at 9 and 12 months. Patients in Group A receive booster vaccination with ALVAC-HIV VCP205 or ALVAC-RG intranasally. Patients in Groups B through G are boosted with AIDSVAX B/B vaccine (a bivalent vaccine consisting of MN rgp120/HIV-1 antigen and GNE8 rgp120/HIV-1 antigen in alum adjuvant) or with Imovax diploid cell rabies vaccine; vaccinations for these patients are given intramuscularly.\] \[AS PER AMENDMENT 11/19/98: The second booster vaccination for group A will be administered at study Month 15.\]

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
84
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
3ALVAC-RG Rabies Glycoprotein (vCP65)Participants will undergo treatment intranasally
4ALVAC-HIV MN120TMG (vCP205)Participants will undergo treatment intrarectally
6MN rgp120/HIV-1 and GNE8 rgp120/HIV-1Participants will undergo treatment intranasally and intramuscularly
1ALVAC-HIV MN120TMG (vCP205)Participants will undergo treatment intramuscularly
6ALVAC-RG Rabies Glycoprotein (vCP65)Participants will undergo treatment intranasally and intramuscularly
1ALVAC-RG Rabies Glycoprotein (vCP65)Participants will undergo treatment intramuscularly
2ALVAC-HIV MN120TMG (vCP205)Participants will undergo treatment orally
3ALVAC-HIV MN120TMG (vCP205)Participants will undergo treatment intranasally
5MN rgp120/HIV-1 and GNE8 rgp120/HIV-1Participants will undergo treatment intravaginally
6ALVAC-HIV MN120TMG (vCP205)Participants will undergo treatment intranasally and intramuscularly
2MN rgp120/HIV-1 and GNE8 rgp120/HIV-1Participants will undergo treatment orally
2ALVAC-RG Rabies Glycoprotein (vCP65)Participants will undergo treatment orally
3MN rgp120/HIV-1 and GNE8 rgp120/HIV-1Participants will undergo treatment intranasally
4MN rgp120/HIV-1 and GNE8 rgp120/HIV-1Participants will undergo treatment intrarectally
4ALVAC-RG Rabies Glycoprotein (vCP65)Participants will undergo treatment intrarectally
5ALVAC-HIV MN120TMG (vCP205)Participants will undergo treatment intravaginally
7MN rgp120/HIV-1 and GNE8 rgp120/HIV-1Participants will undergo treatment intrarectally and intramuscularly
5ALVAC-RG Rabies Glycoprotein (vCP65)Participants will undergo treatment intravaginally
7ALVAC-HIV MN120TMG (vCP205)Participants will undergo treatment intrarectally and intramuscularly
7ALVAC-RG Rabies Glycoprotein (vCP65)Participants will undergo treatment intrarectally and intramuscularly
Primary Outcome Measures
NameTimeMethod
To evaluate the antibody, humoral, and cellular immune responses resulting from ALVAC-HIV vCP205Throughout 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 boostingThroughout study
To compare the safety of ALVAC-HIV vCP205 to that of ALVAC-RG vCP65 rabies glycoprotein, delivered by a variety of mucosal routesThroughout study
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (6)

UAB AVEG

🇺🇸

Birmingham, Alabama, United States

St. Louis Univ. School of Medicine AVEG

🇺🇸

Saint Louis, Missouri, United States

Univ. of Rochester AVEG

🇺🇸

Rochester, New York, United States

JHU AVEG

🇺🇸

Baltimore, Maryland, United States

UW - Seattle AVEG

🇺🇸

Seattle, Washington, United States

Vanderbilt Univ. Hosp. AVEG

🇺🇸

Nashville, Tennessee, United States

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