HIV Vaccine Shows Strong Preliminary Phase I Data
News Dec 02, 2010
Unlike most current vaccines, seeking to eliminate pathogens once they have already entered the bloodstream, Mymetics' vaccines are designed to block early transmission and infection events, preventing virus from settling and spreading within the body. This represents a highly promising but, until now, poorly investigated approach to preventing HIV infection.
The Phase I trial was conducted on 24 healthy women. The vaccine was well tolerated and immunogenic in both low and high dose vaccinated groups. The majority of volunteers developed not only serum antibodies but also mucosal antibodies in the genital and intestinal tracts.
"These new results represent a major achievement for Mymetics," commented Sylvain Fleury, CSO of Mymetics. "Very few HIV vaccine candidates developed over the last 25 years could elicit both blood and mucosal antibodies as a front-line defense mechanism against the entry of HIV-1 across mucosal tissues."
Jacques-François Martin, CEO of Mymetics, added, "Our vaccine represents a first line of defense before the virus can settle in the tissue and spread within the body. These preliminary Phase I results in HIV-1/AIDS represent an important validation of our pioneering work and approach. They also confirm a previous preclinical study where the vaccine provided unprecedented 100% protection in primates."
The Phase I trial, started in December 2009, is a placebo-controlled, double-blind, single-site study, conducted by Prof. G. Leroux-Roels at the Center for Vaccinology (CEVAC) at the University of Ghent (Belgium), under the supervision of Kinesis-Pharma, a CRO under contract with Mymetics. During the vaccination, women received high or low dose vaccinations. The first two injections were performed intra-muscularly and the last two via intra-nasal spray. The final clinical report is expected in January 2011, which will then also include the analysis of the neutralizing characteristics of the antibodies.
HIV-1, the virus that causes AIDS, is primarily transmitted through sexual contact, exposing the mucosal tissues of the genital organs as the first entry door for the virus before it reaches the blood. HIV-1 infected about 2.7 million new people in 2008, while an estimated 2 million people died of AIDS in the same year. HIV-1-related illness remains one of the leading causes of death globally and is projected to remain a significant cause of premature mortality in the coming decades.