Rush is recruiting patients for a Phase I clinical trial to test the safety of an HIV vaccine that has potential to protect healthy people against the disease. This is one of two types of vaccines being tested around the world, according to infectious disease specialist Dr. Beverly Sha. Other HIV vaccine trials involve testing therapies on those already infected. Rush is the only Chicago-area medical center participating in this HIV vaccine study. Merck Pharmaceuticals is funding this phase of the study.

"I think this is the Holy Grail of HIV treatments, to prevent healthy people from getting infected," said Dr. Sha. With 15,000 new HIV infections each day, 95 percent of which occur in developing countries, there are compelling reasons to search for a vaccine, according to Sha. Existing methods of HIV prevention - abstinence, condoms and education - have not reduced the worldwide incidence of HIV.

Patients who enroll in the study will be randomly assigned to one of three regimens: one group will receive a priming vaccine at the start of their enrollment and the HIV-1 DNA gag vaccine with adjuvant aluminum phosphate; another group will receive the HIV-1 DNA gag vaccine with only the adjuvant; and a third group will receive a placebo injection. Adjuvants are substances sometimes included in a vaccine formulation to enhance or modify the immune- stimulating properties of a vaccine.

The vaccines Sha is testing work by using delivery vehicles known as vectors to transport a gene of HIV-1, known as gag into the cells. The HIV-1 gag DNA vaccine uses plasmid, or "naked" DNA as a vector. The HIV-1 gag replication-defective adenovirus vaccine is based on a modified common cold virus, altered so it cannot reproduce and cause illness. The delivery of the HIV-1 gene gag into the cells stimulates the body to generate a potent cellular immune response to HIV-1, producing an army of killer T-cells that recognize and kill HIV-1-infected cells, now and in the future.

Preliminary analysis presented at the 9th Conference of Retroviruses and Opportunistic Infections in February suggests that the HIV-1 gag vaccines for the prevention and treatment of HIV-1 elicit specific antiviral cellular immune responses and are generally well tolerated.

Sha is recruiting healthy patients between the ages 18-50 with no kidney or liver diseases and who are not pregnant. After each injection, patients will be given liver and kidney tests and a double-stranded DNA test to see if the body develops antibodies and an immune response against the DNA. Pathologists will also perform special assays to expose cells to components of the vaccine to see how well they respond.

Rush researchers will examine patients closely for local reactions to the shot, flu-like symptoms or any autoimmune response.

Sha said that if the vaccine is found safe and effective, it would be appropriate for nearly everyone as 100 percent of the population is or becomes sexually active. She indicated that this trial represents significant progress in a search for a preventive measure against HIV.

"While we don't know if this will be effective, we know that there are other sexually transmitted diseases that we have worked on much longer without reaching this point," Sha said. She indicated that patients likely to enroll in this trial are those who have a loved one or close friend who has HIV or AIDS and wants to assist in the search for an effective vaccine.

To enroll in the study, call 312/942-5865.

Rush-Presbyterian-St. Luke's Medical Center includes the 824-bed Presbyterian-St. Luke's Hospital; 110-bed Johnston R. Bowman Health Center; Rush University (Rush Medical College, College of Nursing, College of Health Sciences and the Graduate College).