Subjects: Healthy, HIV-1 uninfected (seronegative) adult volunteers without identifiable higher-risk behavior for HIV-1 infection, as determined by a screening questionnaire.
Schema:
|
GROUP |
N |
WEEKS 0, 8, 24 |
WEEKS 44 and 48 |
||||
|
DOSE (µg) |
ADJUVANT |
ROUTE |
DOSE (µg) |
ADJUVANT |
ROUTE |
||
|
A1 |
5 |
500 |
|
|
500 |
|
|
|
A2 |
5 |
500 |
|
|
500 |
|
|
|
B1 |
5 |
500 |
|
|
500 |
|
|
|
B2 |
5 |
500 |
|
|
500 |
|
|
|
C1 |
2 |
0 |
|
|
500 |
|
|
|
C2 |
2 |
0 |
|
|
500 |
|
|
|
D1 |
3 |
0 |
|
|
500 |
|
|
|
D2 |
3 |
0 |
|
|
500 |
|
|
|
E1 |
1 |
0 |
|
|
NONE |
|
|
|
E2 |
1 |
0 |
|
|
NONE |
|
|
|
F1 |
2 |
0 |
|
|
NONE |
|
|
|
F2 |
2 |
0 |
|
|
NONE |
|
|
|
Total N = |
36 |
||||||
ACCRUAL, IMMUNIZATIONS AND FOLLOW-UP COMPLETED
Product Description: The HIV p17/p24:Ty-VLP contains 25% of p17 and 79% of p24. Together the p17 and p24 components comprise 30% of the mass of the HIV p17/p24:Ty-VLP. Each individual polypeptide has a molecular weight of 66,460 D. The combination of a strong yeast promoter, multiple copies of the expression plasmid and optimized fermentation procedures results in high yields of HIV p17/p24:Ty-VLP. [British Biotechnology, Limited]
Time Period: First volunteer enrolled on 05/04/95 and last on 09/25/95; follow-up of 18 months.
Clinical Sites: University of Alabama at Birmingham, University of Rochester, University of Washington, Vanderbilt University
Study Chairs: Barney Graham and Paul Spearman, Vanderbilt University
INCLUSION CRITERIA
Standard inclusion criteria.
EXCLUSION CRITERIA
Standard exclusion criteria.
STUDY GOALS
The primary objective of this study is to determine the ability of p17/p24:Ty-VLP particles formulated with or without alum to: 1) induce class-I-restricted CD8+ cytotoxic T cells and 2) prime for the induction of mucosal antibody responses after boosting with p24-VLP orally or rectally.