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CUTHIVAC 001

Trial Details

  • Trial statusCompleted
  • Chief InvestigatorSheena McCormack
  • Project managerAleisha Miller
  • SponsorImperial College London
  • ISRCTN numberNA
  • Phase1
  • View clinicaltrials.gov website

A Phase I clinical trial to assess the safety and immunogenicity of three HIV GTUĀ® MultiHIV DNA immunisations administered via the Intramuscular, Intradermal and Transcutaneous routes

Design and Objective

Design: Randomised phase I trial Objective: To assess the safety and immunogenicity in response to three immunisations with a DNA- GTUĀ® MultiHIV B clade vaccine administered via the ID, TC and IM routes, with and without electroporation in a variety of combination regimens.

Key inclusion criteria

1. Men and women aged between 18 and 45 years on the day of screening 2. BMI between 19-30 3. Available for follow-up for the duration of the study (~6 months from screening) 4. Written informed consent 5. At low risk of HIV 6. Willing to undergo a HIV test and a genital infection screen 7. Effective contraception 8. Registered with a GP

Study Disclaimer Statement