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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000886 |
To evaluate the safety of HIV-1 gp120 C4-V3 hybrid polyvalent peptide immunogen (C4-V3 peptides) formulated in mineral oil containing mannose mono-oleate (IFA) in HIV-1 uninfected volunteers. To evaluate the humoral and cellular immune responses to the C4-V3 peptides as measured by the induction of 1 or more of the following: neutralizing antibodies to HIV-1 MN and RF, cross-neutralizing antibodies to primary isolates of HIV-1, HIV-1 antigen-specific lymphoproliferation, CD8+ and CD4+ cytotoxic T lymphocyte (CTL) activity specific for HIV-1 gp120 or V3 peptides corresponding to the vaccine strains of HIV-1, induction of HLA-B7 and HLA-A2 restricted CD8+CTLs, and induction of HIV-specific DTH responses.
The test immunogen (C4-V3 peptides) is constructed from 4 sequences of the HIV-1 V3 gp120 loop shared by approximately 80% of North American HIV-1 strains. Because of the critical role that this region plays in generating anti-HIV sequences, it is hypothesized that the test immunogen (C4-V3 peptides) will be capable of inducing a broad range of cross-reactive neutralizing antibodies in the majority of recipients.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Biological: HIV-1 C4-V3 Polyvalent Peptide Vaccine |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Double-Blind, Safety Study |
Official Title: | A Phase I Safety and Immunogenicity Trial of HIV-1 gp120 C4-V3 Hybrid Polyvalent Peptide Immunogen Mixed in Mineral Oil Containing Mannose Mono-Oleate (IFA) |
Estimated Enrollment: | 28 |
The test immunogen (C4-V3 peptides) is constructed from 4 sequences of the HIV-1 V3 gp120 loop shared by approximately 80% of North American HIV-1 strains. Because of the critical role that this region plays in generating anti-HIV sequences, it is hypothesized that the test immunogen (C4-V3 peptides) will be capable of inducing a broad range of cross-reactive neutralizing antibodies in the majority of recipients.
Twenty-eight volunteers are randomized to receive two 0.5 ml injections of C4-43 peptides in IFA or placebo (IFA alone) administered intramuscularly at 0, 1, 6, and 12 months. At least 50% of all volunteers (6 per Groups I and II; 2, Group III) must be HLA-B7 phenotype.
Ages Eligible for Study: | 18 Years to 60 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:
United States, Tennessee | |
Vanderbilt Univ Hosp | |
Nashville, Tennessee, United States, 37232 | |
United States, Washington | |
Univ of Washington / Pacific Med Ctr | |
Seattle, Washington, United States, 98144 |
Study Chair: | B Graham |
Study ID Numbers: | AVEG 020 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000886 |
Health Authority: | United States: Federal Government |
HIV Antibodies HIV Envelope Protein gp120 Drug Carriers Hypersensitivity, Delayed AIDS Vaccines CD4-Positive T-Lymphocytes CD8-Positive T-Lymphocytes HIV Seronegativity |
Neutralization Tests Mineral Oil Oleic Acids Mannose HLA-B7 Antigen HLA-A2 Antigen HIV Preventive Vaccine |
Sexually Transmitted Diseases, Viral HIV Antibodies Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Virus Diseases Hypersensitivity Antibodies |
Hypersensitivity, Delayed HIV Infections Infectious Mononucleosis Sexually Transmitted Diseases Retroviridae Infections Mineral Oil Immunoglobulins |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Therapeutic Uses Lentivirus Infections |
Infection Dermatologic Agents Pharmacologic Actions Emollients |