Safety & Immunogenicity of HIV Vaccines in Healthy Kenyan Adults
Condition: AIDS
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study is part of a long-term aim to develop an effective HIV-1 vaccine and will evaluate
      safety and immunogenicity of vaccines focusing T cell responses on the conserved region of
      the HIV-1 proteome. The vaccines used are pSG2.HIVconsv DNA (D), MVA.HIVconsv (M) and
      Ad35-GRIN (A), delivered in regimens AM, DDDAM and DeDeDeAM, where e indicates
      electroporation.
    

Detailed description: 
      The main objectives of this study are to determine the vaccines' safety and immunogenicity in
      an African population, and further strengthen the vaccine trial capacity in the South.

      HIV-CORE 004 is a double blind, placebo controlled randomized Phase I/IIa study designed to
      evaluate the safety and immunogenicity of different delivery regimens using three novel HIV-1
      vaccines pSG2.HIVconsv DNA (D) with and without electroporation (e), adenovirus Ad35-GRIN (A)
      and poxvirus MVA.HIVconsv (M) administered by intramuscular needle injection in heterologous
      prime-boost regimens.

      72 healthy, low-risk, HIV-1-uninfected adult volunteers in Nairobi will be randomly assigned
      to one of three groups, AM, DDDAM and DeDeDeAM each containing 20 vaccinees and 4 placebo
      recipients.

      Firstly, this study aims to evaluate the safety and tolerability of the vaccines
      pSG2.HIVconsv DNA (D) with and without electroporation (e), adenovirus Ad35-GRIN (A) and
      poxvirus MVA.HIVconsv (M).

      Secondly, we shall determine the effect of electroporation during DNA priming on the
      frequency, durability and/or quality of T cell responses (DDDAM vs DeDeDeAM).

      Thirdly, we shall determine whether priming with three DNA vaccinations with or without
      electroporation affects the frequency, durability and/or quality of T cell responses to the
      HIVconsv immunogen compared to that seen in the AM regimen (AM vs DDDAM/DeDeDeAM).

      As this is the first study of the combined HIVconsv vaccines in an African population, of the
      pSG2.HIVconsv DNA with electroporation, and the combination of the two HIVconsv vaccines with
      Ad35-GRIN, this trial has been designed as a pilot study to compare different vector
      combinations. The sample sizes will only allow detection of large response differences
      between volunteers in the three groups, thus, yielding data that are primarily descriptive.
    

Intervention name(s): Ad35-GRIN; MVA.HIVconsv; pSG2.HIVconsv DNA; Electroporated pSG2.HIVconsv
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): intramuscular administration of Ad35-GRIN 5 x 10^10 vp or saline placebo; IM administration of MVA.HIVconsv 2 x 10^8 pfu or saline placebo; IM administration of pSG2.HIVconsv DNA 4 mg or saline placebo; IM administration of electroporated pSG2.HIVconsv 4mg or saline placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: HIV; vaccine