At a glance
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Phase I Study: HIV-1 Peptide Immunisation of Individuals in West Africa to Prevent Disease
In Brief
A Phase 1 clinical trial evaluating AFO-18 and Saline for Aids, Cdc Group I. Completed, enrolled 18 participants across 2 sites.
Detailed Summary
Treatment: Immunization with peptide-mix and adjuvant. The vaccine should induce cellular immunity against HIV-1. Target group: Untreated healthy individuals with chronic HIV-1 infection. Purpose: The primary purpose is to evaluate tolerability and safety of the vaccine. The secondary purpose is to evaluate the clinical effect of the vaccination treatment as measured by induction of immunity, lowering of viral load, induction of escape mutations in the virus and improvement in the patient CD4 lymphocyte blood counts. The third purpose is to evaluate the feasibility of conducting a therapeutic HIV immunization study in a poorly-resourced African setting. Design: The experiment is designed as a blinded, placebo-controlled phase 1 clinical trial in HIV-1 infected individuals in West Africa. Numbers of individuals: Phase I: 20 fully evaluable HIV-1-infected patients should enter the study (15 vaccine treated and 5 placebo(saline) treated controls).
Study Details
Timeline
Interventions
18 peptides representing CD8 and CD4 epitopes mainly on HIV-1 in an adjuvants (CAF01)
1.2 ml saline intramuscularly