Volunteers Needed as More AIDS Vaccines Move Into International Trials; Coalition Calls for Global Coordination to Address Challenges Ahead 5/17/2004
From: Mitchell Warren of AVAC, 212-367-1279 or 914-661-1536; mitchell@avac.org NEW YORK, May 17 -- In a major step forward, the AIDS vaccine field is now moving a large number of experimental AIDS vaccine candidates into human clinical trials around the world, the AIDS Vaccine Advocacy Coalition (AVAC) said today in its annual report on the global status of AIDS vaccine research and development. However, this progress could be hindered if the field does not take immediate steps to address key gaps in "readiness" for AIDS vaccine trials, including a possible shortage of healthy volunteers willing to roll up their sleeves to test these potentially promising products, the watchdog group said. "After years of delay, the field is finally moving new vaccine candidates into human testing," said Mitchell Warren, AVAC executive director. "But if we don't significantly step up the pace of recruiting trial volunteers and developing new trial sites, we will never learn whether the new generation of AIDS vaccine candidates has promise." As the AVAC report details, volunteer recruitment is one of several urgent challenges faced by a field that is currently gearing up for five to 10 years of small, medium and large-scale trials. The report cites the example of well-organized efforts to recruit vaccine trial volunteers at a number of international sites including Soweto, the sprawling township outside Johannesburg, where as many as one in three of pregnant women are infected with HIV. Even the Soweto trial unit - which has a vibrant, active community advisory board, innovative outreach programs, and a comprehensive approach to providing care and treatment for all volunteers - must screen up to ten volunteers for every one that actually enrolls in an AIDS vaccine trial. "No matter how big a pool of volunteers you have, you just need more," said Efthyia Vardas, a principal investigator at the Soweto Vaccine Evaluation site in South Africa, which has launched two Phase I preventative AIDS vaccine trials in the past six months. Many of these preparedness challenges are best addressed through coordinated activity among trial sponsors. AVAC has developed a checklist of specific, quantifiable goals that AIDS vaccine researchers, trial sponsors and advocates can use to determine whether they are ready to conduct the multiple vaccine trials that will be needed in the future. "The time for developing and implementing this readiness agenda is now. Eventually, we need many more vaccine candidates moved into efficacy trials. To do this, now we need more vigorous pursuit of unsolved scientific questions, more and better products, and more trial sites in the developing world with improved infrastructure and actual capacity and volunteers to conduct ethical trials," said Warren. As the report states, readiness for the long-term development process requires willing and ready communities and multiple trial sites that are both well-sustained and flexible enough to adapt to changes in plans. The best, if not the only, way to build this type of readiness is by integrating research activities into existing public health systems and current prevention and treatment programs, so that sites do not stand alone and apart, but rather strengthen and partner with services for the community at large. This type of readiness is needed-and lacking-today. "Testing vaccine candidates that fight HIV requires a coordinated international mobilization against a common foe. With an estimated 8,000 deaths a day from AIDS-related illness and 14,000 new infections every day, the world cannot afford any delay in testing products that might prevent infection, illness and death," said Pontiano Kaleebu, a leading AIDS vaccine researcher in Uganda, an AVAC board member, and the chairman of the African AIDS Vaccine Programme. AVAC notes that 13 new vaccine candidates have entered human trials over the past 12 months, and additional promising approaches to an AIDS vaccine, which are already in trials, are expected to move into much larger scale trials in the next several years. The 2004 AVAC report also underscores the need for adolescents to be included in AIDS vaccine trials, and it calls for antiretroviral therapy to be available for free to people in poor communities in the developing world where many vaccine trials will be conducted. The report, entitled "AIDS Vaccine Trials-Getting the Global House in Order," can be accessed at www.avac.org. It is being released today as part of HIV Vaccine Awareness Day activities around the world. AVAC, a watchdog group that accepts no government or pharmaceutical industry funds, began publishing its annual reports on the field in 1997 when former President Bill Clinton vowed to find an AIDS vaccine in 10 years. The group's first report was titled "Ten Years and Counting." The next was "Nine Years and Counting," and the count continued to 2003. This year, however, AVAC has stopped the counting because it has become clear that developing an AIDS vaccine will take much longer than scientists had expected a decade ago. "Despite the long road ahead, this is really a very exciting time," Warren said. "Additional clinical trials are beginning throughout the world, and there is an increased dialogue and potential collaboration between different scientific groups and trial sponsors to tackle difficult scientific challenges." Warren was named AVAC executive director last month. Previously, he was senior director of vaccine preparedness at the International AIDS Vaccine Initiative; a vice-president at The Female Health Co., which makes the female condom; and executive director of Population Services International, which implements social marketing programs to deliver health products, including condoms to prevent HIV infection. He has extensive experience in developing countries, including five years implementing an AIDS prevention program in South Africa. About AVAC AVAC is a not-for-profit, non-partisan community organization dedicated to accelerating the ethical development and global delivery of vaccines for AIDS. It is supported by the Bill & Melinda Gates Foundation, the Ford Foundation, the International AIDS Vaccine Initiative, Until There's a Cure Foundation, WHO- UNAIDS HIV Vaccine Initiative, Broadway Cares/Equity Fights AIDS, the Gill Foundation and individuals who have become AVAC members. For more information, visit http://www.avac.org |