HIV-1 Peptide Immunisation of Individuals in West Africa to Prevent Disease

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Statens Serum Institut
• Collaborators: European and Developing Countries Clinical Trials Partnership (EDCTP); Ministry of the Interior and Health, Denmark
• Treatments: Vaccines

Criteria

Inclusion Criteria:

1. HIV-1 seropositive with measurable viral load >10e3 copies/ml and CD4+ T-cell count >400 CD4+ cells/µl.

2. Not in Antiretroviral Therapy (>1 year).

3. Male or female with age between 18 and 50 years.

4. Normal values for the area of liver and kidney enzymes, blood cell count with differential counts (e.g. white blood cells, lymphocytes, platelets/thrombocytes) and Hemoglobin

5. Expected to follow the instructions.

6. Written informed consent after oral and written information.

Exclusion Criteria:

1. Vaccinated with other vaccines within 3 months before the first vaccination.

2. Treated with immune modulating medicine within 3 month before the first immunization.

3. Other important active chronic infectious diseases likely to influence the HIV-1 infection, like HIV-2, HBV, HCV and TB

4. Significant medical disease as judged by the investigators, for example severe asthma/COLD, badly regulated heart disease, insulin-dependent diabetes mellitus.

5. Severe allergy or earlier anaphylactic reactions.

6. Active autoimmune diseases.

7. Simultaneous treatment with other experimental drugs.

8. Laboratory parameters outside the 'normal' range for the area and which are considered clinically significant.

9. Pregnancy