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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000884 |
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.
Condition | Intervention | Phase |
HIV Infections |
Biological: MN rgp120/HIV-1 and GNE8 rgp120/HIV-1 Biological: ALVAC-HIV MN120TMG (vCP205) Biological: ALVAC-RG Rabies Glycoprotein (vCP65) |
Phase I |
MedlinePlus related topics: | AIDS Rabies |
Drug Information available for: | Krestin Rabies Vaccine Rabies Vaccines |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety Study |
Official Title: | 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 |
Estimated Enrollment: | 84 |
Study Start Date: | November 1997 |
Primary Completion Date: | October 2000 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Participants will undergo treatment intramuscularly
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Biological: ALVAC-HIV MN120TMG (vCP205)
Dosage will vary based on route of administration
Biological: ALVAC-RG Rabies Glycoprotein (vCP65)
Dosage will vary based on route of administration
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2: Experimental
Participants will undergo treatment orally
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Biological: MN rgp120/HIV-1 and GNE8 rgp120/HIV-1
Dosage will vary based on route of administration
Biological: ALVAC-HIV MN120TMG (vCP205)
Dosage will vary based on route of administration
Biological: ALVAC-RG Rabies Glycoprotein (vCP65)
Dosage will vary based on route of administration
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3: Experimental
Participants will undergo treatment intranasally
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Biological: MN rgp120/HIV-1 and GNE8 rgp120/HIV-1
Dosage will vary based on route of administration
Biological: ALVAC-HIV MN120TMG (vCP205)
Dosage will vary based on route of administration
Biological: ALVAC-RG Rabies Glycoprotein (vCP65)
Dosage will vary based on route of administration
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4: Experimental
Participants will undergo treatment intrarectally
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Biological: MN rgp120/HIV-1 and GNE8 rgp120/HIV-1
Dosage will vary based on route of administration
Biological: ALVAC-HIV MN120TMG (vCP205)
Dosage will vary based on route of administration
Biological: ALVAC-RG Rabies Glycoprotein (vCP65)
Dosage will vary based on route of administration
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5: Experimental
Participants will undergo treatment intravaginally
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Biological: MN rgp120/HIV-1 and GNE8 rgp120/HIV-1
Dosage will vary based on route of administration
Biological: ALVAC-HIV MN120TMG (vCP205)
Dosage will vary based on route of administration
Biological: ALVAC-RG Rabies Glycoprotein (vCP65)
Dosage will vary based on route of administration
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6: Experimental
Participants will undergo treatment intranasally and intramuscularly
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Biological: MN rgp120/HIV-1 and GNE8 rgp120/HIV-1
Dosage will vary based on route of administration
Biological: ALVAC-HIV MN120TMG (vCP205)
Dosage will vary based on route of administration
Biological: ALVAC-RG Rabies Glycoprotein (vCP65)
Dosage will vary based on route of administration
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7: Experimental
Participants will undergo treatment intrarectally and intramuscularly
|
Biological: MN rgp120/HIV-1 and GNE8 rgp120/HIV-1
Dosage will vary based on route of administration
Biological: ALVAC-HIV MN120TMG (vCP205)
Dosage will vary based on route of administration
Biological: ALVAC-RG Rabies Glycoprotein (vCP65)
Dosage will vary based on route of administration
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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.]
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Volunteers must have:
Exclusion Criteria
Co-existing Condition:
Volunteers with the following conditions are excluded:
Volunteers with the following prior conditions are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Risk Behavior:
Excluded:
Volunteers with identifiable higher-risk behavior, or whose partners have an identifiable higher-risk behavior for HIV infection as determined by screening questions designed to identify risk factors for HIV infection (i.e., AVEG Risk Groups C or D); specific exclusions include:
United States, Alabama | |||||
Univ of Alabama at Birmingham | |||||
Birmingham, Alabama, United States, 35294 | |||||
United States, Maryland | |||||
Johns Hopkins Univ / School of Hygiene & Public Health | |||||
Baltimore, Maryland, United States, 212051901 | |||||
United States, Missouri | |||||
St Louis Univ School of Medicine | |||||
St Louis, Missouri, United States, 63104 | |||||
United States, New York | |||||
Univ of Rochester Med Ctr | |||||
Rochester, New York, United States, 14642 | |||||
United States, Washington | |||||
Univ of Washington / Pacific Med Ctr | |||||
Seattle, Washington, United States, 98144 |
Study Chair: | P Wright |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | AVEG 027 |
First Received: | November 2, 1999 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00000884 |
Health Authority: | United States: Federal Government |
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