HIV Infections Clinical Trial
Official title:
A Phase I Safety and Immunogenicity Trial of UBI Multivalent HIV-1 Peptide Immunogen in HIV-1 Seronegative Human Subjects
To evaluate, in healthy adult volunteers, the safety and immunogenicity of multivalent HIV-1
peptide immunogen, a formulation of HIV-1 gp120 principal neutralizing domain (PND) branched
synthetic peptides from 15 viral strains representative of diverse worldwide isolates.
Because there is considerable variation among HIV-1 virus strains from differing
geographical locations worldwide, a multivalent peptide vaccine has been constructed to
include prevalent and divergent isolates, potentially providing for wide coverage of
geographically isolated epidemics.
Because there is considerable variation among HIV-1 virus strains from differing
geographical locations worldwide, a multivalent peptide vaccine has been constructed to
include prevalent and divergent isolates, potentially providing for wide coverage of
geographically isolated epidemics.
Fourteen volunteers are entered at one of two dose levels of multivalent candidate vaccine.
At each dose level, 12 volunteers receive vaccine and two receive placebo. At least eight
volunteers at the low dose level must be monitored for 2 weeks before subsequent volunteers
are entered at the high dose. Intramuscular injections are given on days 0, 28, and 168, and
patients are followed for a minimum of 48 weeks after the initial immunization.
Approximately 13 clinical visits are required.
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Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Prevention
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