MUCOVAC2 - safety and immunogenicity of HIV vaccines; version 1
Research type
Research Study
Full title
A Phase I clinical trial to assess the safety and immunogenicity of three HIV CN54gp140 immunisations administered through the intramuscular, intranasal and intravaginal routes in healthy female volunteers
IRAS ID
53035
Sponsor organisation
St George's University London
Eudract number
2010-019103-27
Research summary
Our study is part of the global effort to develop a vaccine against HIV. We have made a copy of the virus's coat protein, and will use it to make three different test vaccines: one for injection into the muscle of the upper arm, one to be given as nasal drops, and one for squirting into the vagina.We will give these vaccines to 36 healthy women volunteers to look for side effects, and also to assess how good the vaccines are at stimulating an immune response. The study will take place at two sites: St George's University of London, and York Hospital.Volunteers will first be assessed to ensure they are eligible to participate. Those who are will be given three doses of vaccine'spaced one month apart, and then monitored for four months after the final dose. The total duration of the study for each participant will be about six months.The injected vaccine will contain a synthetic chemical called GLA (glucopyranosyl lipid adjuvant), which should enhance the immune response, and might enable a smaller dose of viral coat protein to be used.The nasal vaccine will contain a substance called chitosan, which is made from the shells of crustaceans, and should enhance the immune response also.In the vaginal vaccine, the viral coat protein will be mixed into an inactive gel.The coat protein, GLA, chitosan and gel are all experimental substances. For this reason we will monitor very closely the wellbeing of women who participate in our study.
REC name
London - London Bridge Research Ethics Committee
REC reference
11/H0804/5
Date of REC Opinion
24 May 2011
REC opinion
Further Information Favourable Opinion