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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: | NCT00000846 |
To evaluate safety and immunogenicity of 2 different HIV-1 peptide candidate vaccines, the UBI HIV-1 MN PND peptide immunogen and the UBI microparticulate monovalent HIV-1 MN branched peptide when administered sequentially by 2 different routes of immunization, parental priming followed by oral boosting.
Condition | Intervention | Phase |
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HIV Infections |
Biological: HIV-1 Peptide Vaccine, Microparticulate Monovalent Biological: HIV-1 Peptide Immunogen, Multivalent |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Double-Blind, Safety Study |
Official Title: | A Phase I Trial To Evaluate the Safety and Immunogenicity of the UBI HIV-1MN PND Peptide Immunogen, Given by IM Injection, in Combination With the UBI Microparticulate Monovalent HIV-1 MN Branched Peptide Given Orally, in HIV-1 Uninfected Volunteers. |
Estimated Enrollment: | 36 |
After the prescreening, volunteers will be randomized into Group I or Group II. Each group will contain 16 volunteers. At least 5 volunteers in each group must be women. At month 0 all volunteers will receive multivalent HIV-1 peptide immunogen or the placebo. Group I will receive the injection in the deltoid and Group II will receive it in the anterior thigh. At months 1, 2 and 8 all patients will receive microparticulate monovalent HIV-1 peptide or the placebo. Follow up will be conducted.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Patients must have or be:
Risk Behavior: Required:
Exclusion Criteria
Co-existing Condition:
Patients with any of the following symptoms or conditions are excluded:
Patients with any of the following prior conditions are excluded:
Prior Medication:
Excluded:
Risk Behavior:
Excluded:
United States, Alabama | |
Univ of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 | |
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: | Mulligan M |
Study ID Numbers: | AVEG 023 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000846 |
Health Authority: | United States: Federal Government |
Vaccines, Synthetic HIV-1 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 |