The MucoVac2 trial has completed enrolling participants. A total of 36 women are taking part in the trial, which is an early phase HIV vaccine trial, exploring different ways of giving a protein based vaccine, including in a vaginal gel. The final results of the trial should be available in 2013. The trial will provide preliminary information on the safety of the vaccines, and how strongly the immune system responds to it.
The study follows on from MucoVac1, in which the genetically engineered protein was applied only in the vagina. The schedule was very intense, with 9 applications over a three week period, and so it was very disappointing that there were no immune responses. Immunologists suspect this is because the body needs to be primed first, so in MucoVac2, the intravaginal applications follow a more conventional injection into the muscle of the upper arm. Also, most vaccine regimens work on a 'prime and boost' principle, and the applications in MucoVac1 may have been too close together.
The women taking part in MucoVac2 are given vaccinations at the enrolment visit, and then 4 and 8 weeks later. The women are split into 4 groups:
- standard dose protein prime, intravaginal boost at 4 and 8 weeks
- three low dose protein vaccines in the muscle
- three standard dose protein vaccines in the muscle
- three standard dose protein vaccines dripped into the nose