UK HVC Spoke 003
A Phase I clinical trial investigating immunisation strategies using DNA, MVA and CN54rgp140 adjuvanted with GLA-AF to maximise antibody responses
Design and Objective
The primary objective is to determine whether the accelerated regimen, in which MVA and CN54rgp140/GLA-AF are administered during the same visit is safe and elicits similar immunogenicity to the separate immunisations delivered during seven sequential visits as measured by the titre of systemic rgp140-specific binding antibodies four weeks after the final immunisation in each schedule.
Key inclusion criteria
1. Man or woman aged between 18 and 45 years on the day of screening 2. Available for follow-up for the duration of the study (up to ~10 months from enrolment) 3. At low risk of HIV 4. Willing to undergo an HIV test and a genital infection screen if indicated by sexual history 5. Effective contraception 6. Agree to abstain from blood donation