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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) United Biomedical |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000798 |
To evaluate the safety and immunogenicity of a new microparticulate formulation of an HIV-1 MN PND peptide for oral administration in healthy, HIV-1 seronegative adult volunteers at low risk for infection.
Vaccine formulations of synthetic peptides adsorbed to alum may not provide other requisite characteristics of an effective HIV vaccine, such as induction of mucosal immunity, production of cytotoxic T cells, and ease of administration. An oral microparticulate vaccine containing a prototype synthetic peptide has been developed. The microparticles can be degraded over time, inducing both secretory and systemic immune responses.
Condition | Intervention | Phase |
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HIV Infections |
Biological: HIV-1 Peptide Vaccine, Microparticulate Monovalent |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Double-Blind, Safety Study |
Official Title: | A Phase I Safety and Immunogenicity Trial of UBI Microparticulate Monovalent HIV-1 MN Peptide Immunogen in HIV-1 Seronegative Human Subjects |
Estimated Enrollment: | 32 |
Vaccine formulations of synthetic peptides adsorbed to alum may not provide other requisite characteristics of an effective HIV vaccine, such as induction of mucosal immunity, production of cytotoxic T cells, and ease of administration. An oral microparticulate vaccine containing a prototype synthetic peptide has been developed. The microparticles can be degraded over time, inducing both secretory and systemic immune responses.
Twelve volunteers per dose regimen will receive oral microparticulate multivalent HIV-1 peptide vaccine at months 0, 1, and 6, either daily as a low dose for 3 days or a single higher dose. Additionally, four volunteers per regimen will receive placebo. Volunteers are followed for 1 year. They will be contacted once or twice yearly for 5 years to check on health status.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Subjects must have:
NOTE:
Exclusion Criteria
Co-existing Condition:
Subjects with the following symptoms or conditions are excluded:
Subjects with the following prior conditions are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Identifiable higher risk behavior for HIV infection, including the following:
United States, Maryland | |
Johns Hopkins Univ / Ctr for Immunological Research | |
Baltimore, Maryland, United States, 21205 | |
United States, New York | |
Univ of Rochester Med Ctr | |
Rochester, New York, United States, 14642 |
Study Chair: | Lambert J |
Study ID Numbers: | AVEG 018 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000798 |
Health Authority: | United States: Federal Government |
Vaccines, Synthetic HIV-1 Administration, Oral |
AIDS Vaccines HIV Seronegativity HIV Preventive Vaccine |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |