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 GTU® 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- GTU® 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