Important note: Information in this article was accurate in October 2001. The state of the art may have changed since the publication date. Immune Response Corp. announced on August 30, 2001, that it is stopping a study of Remune, a "therapeutic vaccine", due to the withdrawal of funding from Pfizer Inc.'s Agouron Pharmaceuticals. Remune is essentially a dead virus that has been stripped of many of the proteins on its surface. It is used to stimulate a beneficial immune response in patients who are already HIV+, not to prevent an infection. Pfizer's withdrawal was based upon its belief that the drug wasn't meeting the study's main goal of reducing levels of HIV in the bloodstream. However, Immune Reponse Corp. indicated more promising results from a Remune study being conducted in Spain, and the company says it will try to continue studying the therapy on its own. Without other funding, this could be difficult. Immune Response stated in July, 2001, that it had enough cash to fund operations for six months. As of the Newsletter deadline, no information was available as to whether the treatment will remain available to subjects who are currently receiving Remune in clinical trials or compassionate use.
The conference, the first scientific meeting focused on vaccine development, began on September 5, 2001, in Philadelphia. The conference was sponsored by the Foundation for AIDS Vaccine Research and Development, the National Institutes of Health (NIH), the Centers for Disease Control (CDC), UNAIDS, the World Health Organization and the French Agence Nationale Recherches sur le SIDA, and was attended by more than 1,000 AIDS vaccine researchers, public health officials, AIDS community advocates and pharmaceutical company representatives.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), delivered a lecture detailing recent developments in vaccine research and challenges facing researchers as they look for a substance that can prevent infection, or prime the immune system to hold HIV infection in check. "Historically, vaccines have provided safe, cost-effective and efficient means of preventing illness, disability and death from infectious diseases," Fauci noted in a NIH release, adding that a "safe and effective vaccine for HIV infection is a central goal of AIDS research and a necessary tool to bring the HIV epidemic under control." Fauci also detailed the agency's spending projections for fiscal year 2002. NIAID will spend $450.7 million on vaccine research next year, with $276.5 million earmarked specifically for HIV vaccine development.
NIAID is researching about 24 vaccine candidates, 16 of which are specifically designed to fight the a and c HIV subtypes most prevalent in the developing world (NIH release, 9/4). Worldwide, there are approximately 20 candidate vaccines, all made with HIV proteins and genes instead of whole HIV, undergoing human trials. Most are being tested in Phase II studies (safety and effectiveness), but AIDSVAX, developed by Brisbane, California-based VaxGen, is currently undergoing Phase III studies (effectiveness) in 8,000 human volunteers in the United States, Europe and Thailand. AIDSVAX, which works by "provok[ing]" an immune response to keep cells from becoming infected, could be submitted for government approval later this year if the two-year results, due this fall, show an effectiveness rate of 30% or more. If the initial effectiveness is less, AIDSVAX will undergo another year of testing before being considered. Another promising candidate, ALVAC, developed by Aventis Pasteur, works by using canarypox virus cells spliced with HIV genes to initiate a response from T-cells, white blood cells that fight infection and are the main target for HIV. ALVAC is currently being tested for safety in the Americas and Thailand, and NIAID and the Department of Defense are looking to begin testing its effectiveness in the United States and Thailand. (Kaiser HIV Daily Report, 9/5/01)
There has been increasing optimism about an AIDS vaccine recently, with three alleged breakthrough vaccines announced this year, and a fourth unveiled at the Conference in Philadelphia. The success of several vaccine trials in monkeys is the biggest reason for the optimistic mood at the Conference, according to the San Francisco Chronicle. However, many leading researchers warn that this newfound optimism in the field may be based upon misleading science.
There are two disturbing issues of science that critics point to in the recent efforts. The first is that each potential vaccine was tested in monkeys using an artificial monkey AIDS virus. The second is that none of the products to date actually prevents monkeys from getting the virus or sparks the production of antibodies to fight the virus. They do, however, seem to decrease the likelihood that the virus will progress to AIDS and death by boosting some non-antibody elements of the immune system. But even the non-antibody boosting effect may be an artifact of the way the vaccines were tested.
Many researchers are questioning the use of the artificial AIDS virus, designated SHIV89.6p. The SHIV is so different from natural monkey virus (know as SIV) that it produces a different disease, a different immune response, and therefore, critics charge, "protection" against a totally artificial phenomenon. SHIV is made from the outer envelope of HIV, the human virus, along with the inner workings of a strain of SIV.
Vaccine researcher Dennis Burton, of the Scripps Research Institute in La Jolla, Calif., calls the SHIV "a very crash and burn monkey model." In a sense, he says, this SHIV is producing a disease that is like flu: an immediate high fever, acute fatigue, nausea and other symptoms. This indicates to Burton that the immune response to SHIV is radically different from the one animals muster against natural SIV. According to Burton, vaccines that seem to work against SHIV do not usually work against SIV. "And that, to me, is the most worrying thing," Burton says. "I think it would not surprise me if you used all the SHIV-tested vaccines in HIV and they did not protect. Hopes may have been raised too high, too quickly."
None of the new vaccines produces a neutralizing antibody immune effect that prevents infection. Rather, they stimulate the cellular arm of the immune system, boosting the body's ability to slow down the virus' otherwise relentless course towards AIDS.
Vaccine trial volunteers are paid up to $50 a visit for their time and for transportation, but they are not otherwise compensated. According to Barney Graham, head of the vaccine trial unit at the NIH, volunteers "come from all walks of life" and participate for different "personal" reasons, such as the desire to protect their children against the virus or in memory of a loved one who has died of AIDS-related complications. Vaccine candidates do not contain whole HIV and therefore do not pose a risk of infection to volunteers, but the stigma of AIDS may nevertheless "taint" vaccine trial participants, USA Today reports. Vaccine candidates can cause trial volunteers to test positive on some HIV tests. Although more advanced tests can "distinguish" between HIV infection and vaccine response, many potential volunteers do not participate because they are concerned about what could happen if an employer or an insurance company found out they had tested HIV-positive. NIAID gives all vaccine trial volunteers a photo ID card with a toll-free phone number in case an employer or insurance company has a question. Mary Allen, a nurse and community liaison for the agency's Vaccine Trials Network, said she has "never failed to resolve a conflict" of this type.
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