HIV-1 Peptide Immunisation of Individuals in West Africa to Prevent Disease
Status:
Completed
Trial end date:
2012-06-01
Target enrollment:
Participant gender:
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).
Phase:
Phase 1
Details
Lead Sponsor:
Statens Serum Institut
Collaborators:
European and Developing Countries Clinical Trials Partnership (EDCTP) Ministry of the Interior and Health, Denmark