Subjects: Healthy, HIV-1 uninfected (seronegative) volunteers.
Schema:
|
Treatment Schedule |
||||||||
|
|
|
Accrual* |
|
Week 0 Day 0 |
Week 4 Day 28 |
Week 8 Day 56 |
Week 12 Day 84 |
Week 36-52 |
|
I |
|
12 |
s.c. |
X |
X |
X |
X |
X |
|
|
3 |
s.c. |
X |
X |
X |
X |
X |
|
|
II |
|
12 |
s.c. |
X |
X |
X |
X |
X |
|
|
3 |
s.c. |
X |
X |
X |
X |
X |
|
|
Total n = 30 |
||||||||
ACCRUAL, IMMUNIZATIONS AND FOLLOW-UP COMPLETED
Product Description: The HIV-1 gag lipopeptide, P3C541b, is a linear peptide representing a sequence of the HIV gag protein conjugated to a lipid moiety and solubilized for parenteral administration. [United Biomedical, Inc.]
Time Period: First volunteer enrolled on 01/04/95; and the last on 09/26/95. Follow-up extended to 24 weeks (6 months) after last immunization.
Clinical Sites: Johns Hopkins University, Vanderbilt University and University of Washington
Study Chair: David Schwartz, Johns Hopkins University
INCLUSION CRITERIA
Standard inclusion criteria, with the addition of:
EXCLUSION CRITERIA
Standard exclusion criteria.
STUDY GOALS
The aims of this Phase I study are to evaluate the safety and immunogenicity of an HIV synthetic lipopeptide vaccine component - the following specific primary questions will be addressed: a)Are there any adverse clinical reactions to the candidate vaccine (i.e., local or systemic reactions); is there any laboratory evidence of vaccine-induced toxicity?; b) Does the candidate vaccine stimulate CD8+ and/or CD4+ cytotoxic T-cell responses?; c) Is there a dose-response detectable between 70 µg and 350 µg for either toxicity or immunogenicity?
Study Extension: Addition of a fifth dose to obtain additional information about the safety and immunogenicity of the vaccine; specifically, do antibody levels and/or CTL responses increase after a rest period between immunizations?