CUTHIVAC002

• Research type

  Research Study

• Full title

  A Phase I clinical trial to assess the safety and immunogenicity of HIV DNA-C CN54ENV immunisations administered via the Intramuscular and Intradermal methods with and without electroporation followed by boosting with recombinant HIV CN54gp140 in healthy male and female volunteers

• IRAS ID

  181322

• Contact name

  David Lewis

• Contact email

  d.lewis@imperial.ac.uk

• Sponsor organisation

  Imperial College London and Imperial College Healthcare NHS Trust

• Eudract number

  2015-001023-23

• Duration of Study in the UK

  1 years, 5 months, 24 days

• Research summary

  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 0.15ml (0.6mg) DNA intradermal injections into the upper arm with EP and 1 x 0.5ml (2mg) intramuscular injection into the upper thigh without EP at Weeks 0, 4 & 8. And also 1 x 0.1ml (50µg) HIV recombinant protein by intradermal injection into the upper arm at Week 20 (final vaccination).

  Group 2:
  Participants will receive 1 x 0.15ml (0.6mg) DNA intradermal injections into the upper arm without EP and 1 x 0.5ml (2mg) intramuscular injection into the upper thigh with EP at weeks 0, 4 & 8. And also 1 x 0.1ml (50µg) HIV recombinant protein by intradermal injection into the upper arm at Week 20 (final vaccination).

  Group 3:
  Participants will receive 1 x 0.15ml (0.6mg) of DNA of intradermal injections into the upper arm with EP and 1 x 0.5ml (2mg) intramuscular injection into the upper thigh with EP at weeks 0, 4 & 8. And also 1 x 0.1ml (50µg) HIV recombinant protein by intradermal injection into the upper arm at Week 20 (final vaccination).

  We aim to have 8 participants complete the study in each group.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  15/LO/1238

• Date of REC Opinion

  14 Aug 2015

• REC opinion

  Favourable Opinion