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Investigators in 14 cities, including Saint Louis University researchers, are recruiting volunteers to help determine whether two experimental HIV vaccines used in combination can safely stimulate the body's immune system and possibly protect against HIV.
"Of the research conducted to date, this combination HIV vaccine approach holds the most promise," said Robert B. Belshe, M.D., Adorjan Professor of internal medicine, director of the division of infectious diseases and immunology and director of the Center for Vaccine Development at the School of Medicine. Belshe also is the national protocol co-chair for the study, funded by the National Institute of Allergy and Infectious Diseases (NIAID).
According to the NIAID, the development of a safe and effective vaccine to protect people from HIV infection is one of the top public health priorities worldwide. "The study represents an important step in our vaccine development program," Belshe said.
This is the largest study so far for the AIDS Vaccine Evaluation Group. The phase- two study will enroll 420 volunteers. The vaccine approach, called prime boost, combines a primer vaccine with a second vaccine intended to increase, or boost, the immune responses generated by the first. The two vaccines preferentially stimulate different parts of the immune system.
The primer vaccine, vCP205, is made from a canarypox virus used as a carrier for specific HIV genes. The booster vaccine, rgp120, is a genetically engineered copy of an HIV surface protein. Preliminary research has shown that both vaccines are safe and well-tolerated. In smaller clinical trials, this prime-boost combination stimulated both arms of the immune system, neutralizing antibodies (proteins that block the virus from infecting cells) as well as cytotoxic T-lymphocytes (CTLs), so-called "killer T cells," which kill cells that already have become infected.
Belshe emphasized that neither vaccine can cause a person to become infected with HIV. The canarypox virus does not grow inside human cells and therefore cannot cause disease in people. In addition, vCP205 does not carry enough HIV genes to make the whole virus. The booster vaccine, rgp120, contains no live virus.
The study will last two years, with long-term follow-up. Each participant will receive four immunizations over six months and will be tested for HIV infection at three-month intervals. To be eligible to participate, a person must be between 18 and 60, healthy and HIV negative. Study participants will include individuals with a lower risk for acquiring HIV infection as well as those with a higher risk of infection due to injection drug use or unprotected vaginal or anal sex.
The AIDS Vaccine Evaluation Group at Saint Louis University School of Medicine is one of six sites funded by the NIAID, a component of the National Institutes of Health (NIH). NIAID conducts and supports research to prevent, diagnose and treat illnesses such as AIDS and other sexually transmitted diseases, tuberculosis, asthma and allergies. NIH is an agency of the U.S. Department of Health and Human Services.