Safety and Immunogenicity of HIV DNA-C CN54ENV and Recombinant HIV CN54gp140 Vaccines in Healthy Volunteers
Condition: HIV
Study type: Interventional
Phase: Phase 1

Summary: 
      CUTHIVAC002 is a randomised Phase I study aimed at exploring the safety and immunogenicity of
      two different modes of delivery of a deoxyribonucleic acid (DNA) vaccine (DNA-C CN54ENV) via
      combined intramuscular and intradermal methods with and without electroporation, and boosted
      with recombinant HIV CN54gp140 administered by intradermal injection in healthy volunteers.

      The aim of this study is to identify optimal DNA delivery conditions for promoting enhanced
      antibody responses to boosting with recombinant protein by the intradermal method.
    

Detailed description: 
      CUTHIVAC002 is a randomised Phase I study in healthy volunteers, aimed at exploring the
      safety and immunogenicity of two different modes of delivery of a deoxyribonucleic acid (DNA)
      HIV vaccine via combined intramuscular and intradermal methods with and without
      electroporation (EP), and boosted with recombinant HIV protein vaccine administered by
      intradermal injection without EP.

      The aim of this study is to identify optimal DNA delivery conditions for promoting enhanced
      antibody responses to boosting with recombinant protein by the intradermal route. Healthy
      male and female volunteers aged 18 to 50 years old, who are at low risk of HIV infection, are
      to be recruited. The participants will be divided into 3 groups:

      Group 1:

      Participants will receive 1 x 0.15 ml (0.6 mg) DNA intradermal injections into the upper arm
      with EP and 1 x 0.5 ml (2 mg) intramuscular injection into the upper thigh without EP at
      Weeks 0, 4 & 8. And also 1 x 0.1 ml (50 μg) HIV recombinant protein by intradermal injection
      into the upper arm at Week 20 (final vaccination).

      Group 2:

      Participants will receive 1 x 0.15 ml (0.6 mg) DNA intradermal injections into the upper arm
      without EP and 1 x 0.5 ml (2 mg) intramuscular injection into the upper thigh with EP at
      weeks 0, 4 & 8. And also 1 x 0.1 ml (50 μg) HIV recombinant protein by intradermal injection
      into the upper arm at Week 20 (final vaccination).

      Group 3:

      Participants will receive 1 x 0.15 ml (0.6 mg) of DNA of intradermal injections into the
      upper arm with EP and 1 x 0.5 ml (2 mg) intramuscular injection into the upper thigh with EP
      at weeks 0, 4 & 8. And also 1 x 0.1 ml (50 μg) HIV recombinant protein by intradermal
      injection into the upper arm at Week 20 (final vaccination).

      The investigators aim to have 8 participants complete the study in each group.
    

Intervention name(s): DNA-C CN54ENV; CN54gp140; Trigrid Delivery System - Intramuscular; Trigrid Delivery System - Intradermal
Intervention type(s): Biological; Biological; Device; Device
Intervention description(s): DNA plasmid containing the Clade C gp140 envelope gene from HIV-1 isolate CN54; Recombinant protein expressed from the Clade C gp140 envelope gene from HIV-1 isolate CN54; Electroporation; Electroporation
Other intervention name(s): TDS-IM; TDS-ID
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: safety; immunogenicity; HIV vaccine