A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Vaccine Component P3C541b in HIV-1 Seronegative Human Subjects
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.
|Study Design:||Endpoint Classification: Safety Study
Primary Purpose: Prevention
|Official Title:||A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Vaccine Component P3C541b in HIV-1 Seronegative Human Subjects|
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.
|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|