HIV Vaccine Study in HIV Positive Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to see whether a single vaccination (injection) with the
      investigational HIV vaccine is safe and effective in patients who are HIV positive but have
      not yet begun anti-retroviral therapy. As this is an exploratory study, four different dose
      formulations of HIV vaccine will be investigated.

      This study will evaluate whether or not the HIV vaccine is able to reduce the HIV viral load
      (number of HIV virus particles in the blood) and increase or slow the decline in CD4 T cell
      count.
    

Detailed description: 
      The study will consist of a screening period of 3 to 21 days before vaccination on Day 0 and
      a double-blind treatment period of 28 days with a follow up period of 5 months. Prior to
      conducting any study-related procedures, subjects will provide written informed consent.
      During screening, eligibility will be assessed, a medical history will be taken, a complete
      physical examination will be performed and vital signs will be measured. Blood samples will
      be taken for the assessment of HCV and HBV status. Further samples will be taken for CD4 and
      HIV load, haematology, biochemistry, urinalysis and a 12-lead electrocardiographic (ECG)
      assessment will be carried out. A self-assessment diary card will be used by subjects between
      Day 0 and Day 28 to record any AEs.

      On Days 7, 14, 21 and 28 an AE interview will be conducted, concomitant medications and vital
      signs will be recorded and a physical examination will be performed. Samples will be
      collected for haematology, clinical chemistry and urinalysis. In addition, samples will be
      collected for CD4 T cell count and HIV viral load at days 14 and 28 after vaccination. A
      sample will be collected for immunogenicity on Day 28.

      All patients will attend follow-up visits at Weeks 8, 12, 16, 20 and 24 at which a physical
      examination and examination of the injection site will be performed and vital signs measured.
      Samples will be collected for haematology, biochemistry, urinalysis CD4 T-cell count and HIV
      viral load. Blood samples for immunogenicity testing will be collected at Weeks 12 and 24.

      Stage I: Sequential, non-randomised, single blind, parallel group. Five male HIV-1 positive
      volunteers will be vaccinated in a sequential, non-randomised single blind fashion. They will
      each receive one of the five possible active study treatments (WFI only, adjuvant only, low
      dose + WFI, low dose + adjuvant, high dose + WFI and high dose + adjuvant). Each of these
      five patients will be observed as in-patients for 24 hours after vaccination and vaccinations
      will be performed in a sequential manner with at least 48 hours observation of each patient
      before vaccination of the next patient is commenced.

      Following completion of the '28 day treatment follow up' by the five Stage I subjects a
      Safety Committee will review the safety and tolerability data for these subjects and will
      make a recommendation for continuing or discontinuing recruitment and any changes that may be
      required in the conduct of the study. Subject to a positive decision from the Safety
      Committee the remaining subjects will be recruited into Stage II of the study.

      Stage II: randomised, double-blind group 50 male HIV-1 positive volunteers will be randomised
      to one of five possible treatment groups. Following completion of the Day 1 Visit by the
      first five subjects in Stage II the Safety Committee will review the blinded safety and
      tolerability data for these subjects. Subject to acceptable safety and tolerability, the
      centres will be allowed to continue recruitment for the rest of the planned cohort.

      After 25 Stage II subjects have completed the Day 1 Visit a Safety Committee will review the
      blinded data generated and will make a recommendation for continuing or discontinuing
      recruitment and any changes that may be required in the conduct of the study.
    

Intervention name(s): HIV-v (Low Dose); HIV-v (High Dose); HIV-v (Control)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Low Dose HIV-v (a sterile lyophilised mixture of polypeptide T-cell epitope sequences) with water for injection or adjuvant
Administration: A single subcutaneous injection; High Dose HIV-v (a sterile lyophilised mixture of polypeptide T-cell epitope sequences with water for injection or adjuvant
Administration: A single subcutaneous injection; Adjuvant only or Water for injection only
Administration: A single subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Safety; Tolerability; Immunogenicity; Human Immunodeficiency Virus; HIV-1; Vaccine; CD4; Viral Load; HIV