HIV-1 Peptide Immunisation of Individuals in West Africa to Prevent Disease
Condition: Aids, Cdc Group I
Study type: Interventional
Phase: Phase 1

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).
    

Detailed description: 
      The HIV infection does not leave lifelong immunity, but leads to break down of the immune
      system, opportunistic infections and death. The immunity obtained by the infection itself can
      only partially contain the HIV infection. The purpose with a targeted therapeutic vaccination
      is therefore in addition to the existing immunity to induce a broader, more powerful and more
      rationally or better directed immunity than the one induced by the "natural" HIV-1 infection.
      This would potentially lower the viral load in the blood making it more difficult to spread
      the virus to others and prolong the time to AIDS disease and medical treatment. There is a
      need for new rational vaccination possibilities, able to prevent (HIV) disease, postpone the
      need for antiretroviral medical treatment, prolong the life, and limit spread of HIV-1 in the
      population. The present protocol seak to introduce such a new immune treatment principle for
      HIV-1 infected individuals. In this study, individuals with chronic HIV-1 infection will be
      vaccinated with selected synthetic HIV immune-peptides representing new discovered conserved
      target´s on the virus. The vaccine should induce new immunity against several epitope targets
      on their HIV, whereby the HIV infection may be controlled for a longer time by the immune
      system. The purpose of the study is primarily to evaluate the safety and tolerability of the
      vaccine and secondary to evaluate the immunological and antiviral response in the vaccinated
      individuals.
    

Intervention name(s): AFO-18; Saline
Intervention type(s): Biological; Drug
Intervention description(s): 18 peptides representing CD8 and CD4 epitopes mainly on HIV-1 in an adjuvants (CAF01); 1.2 ml saline intramuscularly
Other intervention name(s): CAF01; HIV-1 peptides; NaCl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: AIDS vaccines; HIV-1 vaccine; Therapeutic vaccine; Cellular immunity