HIV-1 Peptide Immunisation of Individuals in West Africa to Prevent Disease
Condition: Aids, Cdc Group I
Intervention: AFO-18; Saline
Intervention description: 18 peptides representing CD8 and CD4 epitopes mainly on HIV-1 in an adjuvants (CAF01); 1.2 ml saline intramuscularly
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: AIDS vaccines; HIV-1 vaccine; Therapeutic vaccine; Cellular immunity

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).
    

Eligibility 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