What is AIDSVAX®?
AIDSVAX is the trade name for all formulations of VaxGen’s preventive AIDS vaccines. It is the first and only preventive AIDS vaccine to advance to Phase III testing, the final stage before regulatory approval can be sought.
Is AIDSVAX a cure or a treatment for AIDS?
No. AIDSVAX is designed to prevent infection by HIV, not to cure people who are already infected.
Is there any risk of contracting HIV or AIDS from the vaccine?
No. AIDSVAX cannot cause HIV infection or AIDS. It’s made from a synthetic protein and contains no genetic material from HIV.
How safe is AIDSVAX?
Safety has been the primary consideration in the development of AIDSVAX. More than 27,000 doses have been administered since human testing first began in 1992. The independent board of scientists and researchers that oversees the testing of AIDSVAX has conducted six analyses of the Phase III trials to evaluate safety as well as trial conduct. They have repeatedly found the vaccine to have an excellent safety profile and that the trials are being conducted appropriately.
What is a Phase III trial?
The Phase III trials of AIDSVAX are placebo-controlled, double-blind tests to determine how well the vaccine works in humans. The two tests (one in North America and Europe and another in Thailand) involve nearly 8,000 HIV-negative individuals who are part of specific populations at risk of becoming infected. A Phase III trial is the final phase of testing before regulatory approval can be sought. Before AIDSVAX could advance to a Phase III trial, it had to pass a Phase I trial, where it was tested for safety, and a Phase II trial, where it was tested for safety as well as its ability to induce antibodies.
When will you have the results of the Phase III trial?
The Phase III study of AIDSVAX in North America and Europe is scheduled to conclude at the end of 2002, with results available in early 2003. The Thai study is scheduled to conclude in the summer of 2003.
How will you be able to tell if AIDSVAX works?
The primary goal of the Phase III studies are to measure how well AIDSVAX prevents HIV infection. This will be determined by comparing the number of infections in the placebo group of volunteers to the number of infections in the vaccine group.
In addition to evaluating how well AIDSVAX prevents HIV infection, data from the trials will be examined to evaluate the effect and potential benefits of the vaccine on any study volunteers who became infected with HIV despite being vaccinated.
How does AIDSVAX work?
AIDSVAX follows the same established principles used to create successful vaccines against smallpox, polio, measles and other diseases. All these vaccines, including AIDSVAX, prevent infection by inducing antibodies. AIDSVAX, however, contains no genetic material from the disease it prevents. It’s made from a synthetic protein and contains no genetic material from HIV.
How is AIDSVAX made?
AIDSVAX is made from a synthetic clone of a protein found on the surface of HIV, gp120. Using recombinant DNA technology, the gene for gp120 is cloned and then duplicated by Chinese hamster ovary cells in commercial-scale fermenters. The gp120 is then purified and mixed with alum, and adjuvant that boosts the immune response, to create AIDSVAX.