February 24, 2003
NEW YORK, 24 February 2003—VaxGen Inc. announced today that its investigational AIDS vaccine, AIDSVAX, although safe, did not prove effective in human trials in North America and Europe. AIDSVAX was designed to prevent people who are uninfected with HIV from contracting the virus or developing AIDS. AIDSVAX is the first AIDS vaccine ever fully tested in humans.
In the trial, 3330 volunteers received AIDSVAX, and 1679 received a placebo (an inactive substance). The percentage of volunteers who received AIDSVAX and became infected with HIV is statistically equal to the percentage of volunteers who received the placebo and became infected with HIV. This means that the vaccine is not protective.
In response, Seth Berkley, MD, President and CEO of the International AIDS Vaccine Initiative (IAVI), released this statement:
"The news on VaxGen's AIDSVAX is disappointing, but we are not discouraged. The search for an AIDS vaccine will—and must—go on. A vaccine is the world's best hope to end the spread of a virus that infects nearly 15,000 men, women and children daily and threatens the survival of whole communities.
"Scientists remain confident that an AIDS vaccine is possible. Alternative AIDS vaccines, employing different design strategies, are now in development, and some have already entered human trials. These must move forward through further study, without delay.
"The results on AIDSVAX must be further analyzed, and independently reviewed. For example, VaxGen's preliminary analysis of the small number of nonwhite volunteers suggests that there were fewer infections among black volunteers who received AIDSVAX than blacks who received the placebo. However, it is difficult to draw conclusions about what this means, given that the number of blacks in the study was so small (VaxGen's analysis is based on just 13 infections among black volunteers, 4 in the vaccine group and 9 in the placebo group).
"HIV is a tough adversary, and there will inevitably be more setbacks, but with perseverance the world will find a vaccine. Success will require the best science, and a sustained commitment, from industry, academia and government.
"Lack of research funding continues to stymie progress toward an AIDS vaccine, and the world must step up funding. Currently, expenditures on AIDS vaccines total less than 1% of all health and pharmaceutical research.
"The world must prioritize AIDS vaccine research that is tailored for the developing countries that are hardest hit by the epidemic. If AIDSVAX had proved effective in the trial in North America and Europe, we would not have known if the vaccine is protective in Africa, India or China, where there are different subtypes circulating.
"IAVI salutes VaxGen for their leadership in taking the first AIDS vaccine candidate through the rigors of human trials. VaxGen demonstrated that a large trial of an AIDS vaccine could be completed with high retention of volunteers, and that the volunteers would not increase their risk behavior. IAVI also thanks the thousands of volunteers who participated in the study of AIDSVAX, or in trials of other AIDS vaccines. We thank the many more volunteers who will take part in future trials."