RV 144, or the Thai trial, is the name of an HIV vaccine clinical trial combining two vaccines that failed on their own, vaccinating in Thailand over the course of 24 weeks in October 2003 then testing for HIV until July 2006 , publicly releasing efficacy findings in September 2009. The initial report shows that the rate of HIV infection among volunteers who received the experimental vaccine was 31% lower than the rate of HIV infection in volunteers who received the placebo.
The trial collaborators have stated that results of this trial give the first supporting evidence of any vaccine being effective in lowering the risk of contracting HIV. On October 20[when?], the organizers released full results of the study through publishing in the New England Journal of Medicine and presented them at the AIDS Vaccine Conference in Paris.
A total of 16,402 Thai volunteers aged 18–30 were recruited to participate in Chon Buri and Rayong Provinces in Thailand. These volunteers were randomized into double-blind study groups, with those in the experimental group receiving a phase III prime-boost HIV vaccine. Eligibility criteria for participation in the study required that all volunteers be HIV negative prior to enrollment in the study and be willing to participate in educational counseling intended to teach ways to reduce risk behavior associated with contracting HIV. After being vaccinated, volunteers were asked to receive HIV testing every six months for three years, as well as receive additional risk-behavior counseling at every testing visit.
During the study, 125 of the 16,402 participants contracted HIV through behavior unrelated to their study participation. Of those 125, 74 infected persons had received placebo and 51 had received the vaccine. It is statistically significant that the group which received the vaccine has an infection rate 31.2% lower than the group who received placebo.
A separate but related result is that the vaccine regimen had no effect on the amount of virus in the blood of volunteers who became HIV-infected during the study.
As with all major studies, the data for this one were analyzed in different ways for different interpretations.
In a study in September 2011, researchers involved with the trial at Mahidol University in Bangkok and the United States Military HIV Research Program in Washington DC tested the blood of trial subjects for different immune indicators between those who received the vaccine and contracted HIV (41 subjects) and those who did not become infected (205 subjects).
Their work is not complete, but those in the study who produced IgG antibodies that recognise the V2 loop in the HIV envelope protein gp120 were 43% less likely to become infected. Those who produced envelope specific IgA were 54% more likely to become infected, but no more susceptible than trial subjects receiving the placebo.
The immune responses of uninfected patients could point the way to more fruitful research. Nelson Michael, director of the U.S. Military HIV Research Program, says that results lend "biological credence to the initial clinical study results".
The vaccine was found to be safe, well tolerated, and suitable for large-scale further research.
Over six months, volunteers received a prime-boost vaccination including six injections of a vaccine called ALVAC HIV (vCP1521) with the last two of the six injections being a combination of that vaccine and another one called AIDSVAX B/E (gp120).
ALVAC‐HIV (vCP1521) consists of a viral vector containing genetically engineered versions of three HIV genes (env, gag and pol). The ALVAC vector is an inert form of canarypox, which is a bird virus which cannot cause disease or replicate in humans. AIDSVAX B/E is composed of genetically engineered gp120, a protein on the surface of HIV.
RV 144 is sponsored by the Surgeon General of the United States Army and conducted by the Thailand Ministry of Public Health with support from the United States Army Medical Research and Materiel Command and the National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health.
ALVAC‐HIV (vCP1521) was manufactured by Sanofi Pasteur. AIDSVAX B/E was manufactured by Genentech under a license and supply agreement with VaxGen, which itself is a spin-off company of Genentech founded for the purpose of developing AIDSVAX. Global Solutions for Infectious Diseases, a nonprofit organization co‐founded by former VaxGen executives, has ownership of certain intellectual and manufacturing rights of AIDSVAX.
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