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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: | NCT00000845 |
To evaluate an HIV synthetic lipopeptide candidate vaccine component, P3C541b, at two dose levels, administered subcutaneously (s.c.) in a randomized, double-blind, placebo controlled study.
Condition | Intervention | Phase |
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HIV Infections |
Biological: P3C541b Lipopeptide |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Double-Blind, Safety Study |
Official Title: | A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Vaccine Component P3C541b in HIV-1 Seronegative Human Subjects |
Estimated Enrollment: | 30 |
The prospective volunteers will be screened and HLA typed for Class I MHC haplotypes. Only volunteers possessing HLA alleles A33, B8, B27, B35 or Bw62 or any combination thereof will be enrolled in the study. Subjects will be allocated to 1 of 2 study groups. Group 1 will receive 70 mcg of P3C541b or the placebo and Group II will receive 350 mcg of P3C541b or the placebo. NOTE: Enrollment for Group II wil not begin until at least 5 Group I participants have reached day 14 without serious adverse events.
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:
NOTE:
Prior Treatment:
Excluded:
Risk Behavior:
Excluded:
United States, Maryland | |
Johns Hopkins Univ / School of Hygiene & Public Health | |
Baltimore, Maryland, United States, 212051901 | |
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: | Schwartz D |
Study ID Numbers: | AVEG 021 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000845 |
Health Authority: | United States: Federal Government |
Vaccines, Synthetic 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 |