Immunization With HIV-1 Peptides in Adjuvant for Treatment of Patients With Chronic HIV-infection
Condition: HIV INFECTIONS
MeSH terms: Infections; HIV Infections; Acquired Immunodeficiency Syndrome
Intervention: peptide vaccine (AFO-18)
Intervention description: 18 Peptides (250 ug of each peptide) in Adjuvant CAF01 (= 625/125 ug DDA/TDB), i.m. injection week 0, 2, 4, 8.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: VACCINE; THERAPY; CELLULAR IMMUNITY; IMMUNITY

Summary:

      Treatment: Immunization with a peptide-mix of 17 Clusters of Differentiation number 8 (CD8) T
      cell minimal epitopes and 3 Clusters of Differentiation number 4 (CD4) T cell epitopes and a
      new adjuvant (CAF01). The vaccine should induce cellular immunity against human
      immuno-deficiency virus type-1 (HIV-1).

      Target group: Untreated healthy individuals with chronic HIV-1 infection who are not in
      antiretroviral treatment.

      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 new T cell immunity, lowering of HIV-1 ribonucleic acid (RNA) viral
      load in plasma, and improvement in the patient CD4 lymphocyte blood counts.

      Design: The experiment is designed as a single-blinded, placebo-controlled phase 1 clinical
      trial in HIV-1 infected individuals in Denmark.

      Numbers of individuals: 20 fully evaluable HIV-1-infected patients should enter the study (15
      vaccine treated and 5 placebo(saline) treated controls).

      The hypothesis is that a redirection of cytotoxic T lymphocyte (CTL) immunity to selected
      relatively immune silent (subdominant) but conserved CTL targets on multiple sites in HIV-1
      could provide a better immune control of the virus replication. This could result in lowering
      of viral load thereby prolonging the time to antiretroviral therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-1 seropositive with measurable viral load >10e3 copies/ml and CD4+ T-cell count
             >400 CD4+ cells/µl

          -  Not in Antiretroviral Therapy (>1 year)

          -  Male or female with age between 18 and 60 years, where females are not breastfeeding,
             are not pregnant and use contraception until at least 3 months after end of
             vaccinations

          -  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

          -  Expected to follow the instructions

          -  Written informed consent after oral and written information

        Exclusion criteria:

          -  Vaccinated with other experimental vaccines within 3 months before the first
             vaccination

          -  Treated with immune modulating medicine within 3 month before the first immunization

          -  Other significant active chronic infectious diseases likely to influence the HIV-1
             infection, like Hepatitis B Virus (HBV), Hepatitis C Virus (HCV)

          -  Significant medical disease as judged by the investigators, for example severe
             asthma/chronic obstructive lung disease (COLD), badly regulated heart disease,
             insulin-dependent diabetes mellitus

          -  Severe allergy or earlier anaphylactic reactions

          -  Active autoimmune diseases

          -  Simultaneous treatment with other experimental drugs

          -  Laboratory parameters outside the 'normal' range for the area and which are considered
             clinically significant

          -  Pregnancy and/or brest feeding