Cervico-vaginal CN54gp140-hsp70 conjugate vaccine
Research type
Research Study
Full title
Phase I clinical trial in healthy female volunteers of reactogenicity and immunogenicity of three cervico-vaginal topical immunisations with a fixed dose of HIV CN54gp140 glycoprotein-hsp70 conjugate vaccine
IRAS ID
63773
Sponsor organisation
St Georges University of London
Eudract number
2010-022740-20
Clinicaltrials.gov Identifier
Research summary
A vaccine to prevent infection with the Human Immunodeficiency Virus (HIV) is urgently needed, as treatments for HIV/AIDS are expensive, toxic and do not cure the infection. Worldwide, most HIV infections occur through sex between a man and woman. Injected vaccines are not successful at creating immune protection in the female genital tract - where the virus is most likely to enter. The vaccine in this study consists of a protein from HIV that has been synthetically produced and linked to a protein that boosts immune responses. It has not been tested in humans before, but it is expected (from animal studies) that direct application into the female genital tract (via the vagina) as liquid drops, will provoke immune protection at the site of HIV infection. This is less applicable to men, therefore only healthy, HIV negative women will be recruited. We will recruit at one site, which is a university vaccine research centre with experience of running similar trials. The study will last 24 weeks during which subjects will have blood samples taken on six visits, and three immunisations over 12 weeks in which 0.5 millilitres of vaccine's placed into the vaginal by inserting a small plastic syringe.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
11/LO/0459
Date of REC Opinion
23 Jun 2011
REC opinion
Further Information Favourable Opinion