PR Newswire; Tuesday December 16, 1:23 pm EST

Dubbed the St. Jude multi-envelope AIDS vaccine, it is designed to trigger an immune response to multiple, differing isolates of HIV from various world regions using the harmless outer coating of HIV known as the envelope. Consequently, it may confer protection against many of the virus' strains now circulating or likely to circulate worldwide.

The St. Jude multi-envelope AIDS vaccine is the latest product of a decade-long commitment to treating and preventing pediatric AIDS that began with the hospital helping to prove over the last ten years that AZT (ZDV) dramatically decreases the transmission rate of HIV from infected mothers to newborns.

The developers of the St. Jude multi-envelope vaccine, Drs. Karen Slobod and Julia Hurwitz, exemplify the team approach to patient care that makes St. Jude Children's Research Hospital so successful and well-respected. Karen Slobod, M.D., a member of St. Jude's Department of Immunology, chaired by the 1996 Nobel Prize-winner Dr. Peter Doherty, is the physician member of the team, but she also spends much time in the laboratory working on a number of projects, including novel treatments for people with AIDS.

Julia Hurwitz, Ph.D., a member of St. Jude's Department of Infectious Diseases, has a track record of working on the development of a number of other vaccines, including a possible Epstein-Barr virus vaccine. Together these two are accomplishing what St. Jude has done extremely well since opening in 1962: translating laboratory findings into innovative treatments for the benefit of children around the world.

For four years, Drs. Slobod and Hurwitz gathered HIV isolates from around the world to create their vaccine. They used the harmless HIV coating called an envelope because envelope vaccines have been shown in other laboratories to protect safely primates challenged with an immunodeficiency virus sharing the same HIV envelope (Proceedings of the National Academy of Sciences 8/97). The St. Jude multi-envelope vaccine uniquely combines 23 different envelopes representing many different strains of HIV from various world regions, so it may confer protection against many strains of HIV.

"Our ultimate aim is to discover the number and mix of HIV proteins, gathered from HIV isolates throughout the world, which will be effective in preventing infection regardless of the isolate to which people are exposed," says Dr. Hurwitz.

The phase I safety trial recently approved by the FDA is underway with the recruitment of 9 to 18 eligible, healthy, human volunteers. Drs. Slobod and Hurwitz expect the trial to be completed in about two years, with safety data available soon after.

The St. Jude multi-envelope AIDS vaccine has its roots the St. Jude HIV/AIDS clinical program, directed by Patricia Flynn, M.D. Since its founding at the beginning of the AIDS epidemic in this country in the late 1980's, St. Jude's program has been devoted to developing and evaluating treatments for children with AIDS. The primary goal of the St. Jude HIV/AIDS clinical program is to prevent pediatric AIDS, one that most experts agree can best be accomplished with a vaccine.

As part of its commitment to helping prevent pediatric AIDS, St. Jude was one of only a dozen institutions in the late 1980's that tested AZT as a means to reduce transmission of HIV from an infected mother to her newborn during delivery. At that time, one in four children born to untreated HIV-positive mothers developed the infection themselves.

Now, partly as a result of data gathered at St. Jude showing that AZT does indeed reduce transmission, AZT treatment of identified HIV-infected mothers is standard practice in this country, which has cut the transmission rate to less than one in ten newborns. But doctors at St. Jude agree that even one infected baby is too many. Consequently, they have joined their colleagues at other institutions in providing HIV-infected mothers with new retroviral treatment regimens or a combination therapy with protease inhibitors to see if they can cut the rate to zero.

In 1992, St. Jude enhanced its clinical program by joining the newly established National Institutes of Allergy and Infectious Diseases (NIAID) Pediatric AIDS Clinical Trials Group (ACTG). As a member of the Pediatric ACTG, St. Jude continues its tradition of improving treatment for AIDS by evaluating the safety and efficacy of the newest generation of antiretrovirals designed to stop perinatal transmission of HIV, including D4T and NVP. Also among its 14 research protocols during 1997 are long-term follow-up studies of infected and uninfected children exposed to AZT (ZDV) or other retrovirals during pregnancy to determine if they suffered side-effects.

In 1997, St. Jude demonstrated its commitment to the growing number of adolescents with AIDS by joining the National Institutes of Child Health and Development's (NICHD) Reaching for Excellence in Adolescent Care and Health (REACH) program. St. Jude received a grant from the NIAID and NICHD to study the effects of HIV infection on teenagers' growth and development and psychosocial functioning. St. Jude doctors are also evaluating how co- infection with sexually transmitted diseases affect the course of AIDS in teenagers. As for all its research volunteers, St. Jude provides comprehensive health care services for teens in its REACH program.

Some of the ongoing studies at St. Jude include testing therapies that may boost the immune system of people with AIDS; when and how much AZT doctors should give to infected pregnant women in order to minimize the risk of transmitting HIV to their babies; and, the effectiveness of the influenza vaccine in HIV-infected children.

St. Jude Children's Research Hospital, in Memphis, Tenn., was founded by the late entertainer Danny Thomas. The hospital is an internationally recognized biomedical research center dedicated to finding cures for catastrophic diseases of childhood. The hospital's work is primarily supported through funds raised by the American Lebanese Syrian Associated Charities (ALSAC). All St. Jude patients are treated regardless of their ability to pay. ALSAC covers all costs of treatment beyond those reimbursed by third party insurers, and total costs for families who have no insurance.

SOURCE: St. Jude Children's Research Hospital

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