Clinical Trial for HIV Vaccine

A new autologous vaccine tested by researchers at UMDNJ-New Jersey Medical School (NJMS) appears to be a safe and effective therapy for controlling HIV infection. The treatment, which is based on the person’s own virus and cells, is designed to stimulate a different and stronger immune response to the specific virus subtypes with which they are infected.

The clinical trial involved 10 HIV-infected individuals, nine children and one adult. They were treated over a six-year period with an innovative therapy developed by BioDelivery Sciences International, Inc. (BDSI), a New Jersey-based bio-tech company whose founders include two NJMS faculty members, Raphael Mannino, PhD, and Susan Gould-Fogerite, PhD. After 44 total study doses, no adverse reactions were observed in the patients. Most subsequently received combination anti-retroviral drug therapy, and since then have maintained stable low viral levels. At last evaluation (August 2001) all patients had no progression of disease and reported subjective improvement, especially with regard to quality of life. The principal investigator of the study was James M. Oleske, MD, François-Xavier Bagnoud Professor of Pediatrics and director of the Division of Allergy, Immunology, Infectious and Pulmonary Diseases at NJMS.

During the trial, the number and percentage of CD4+ cells increased, or the rate of decline decreased, in nine of the patients. This change is significant because these cells, crucial to the functioning of a healthy immune system, are typically destroyed during HIV infection.

In addition, gamma interferon ELISPOT assays recently were performed on cells that had been frozen at various time points prior to and during the trial. "Encouragingly, these studies indicated that five of the patients developed HIV-specific cytolytic T cell activity during the trial," Oleske says. "This type of killer cell plays a very important role in killing infected cells and controlling the HIV virus infection."

The researchers believe the treatment is the first autologous therapeutic HIV vaccine as well as the only therapeutic vaccine candidate with a follow-up of more than six years.

BDSI is developing a patented delivery technology designed for a broad base of pharmaceuticals, vaccines, over-the-counter drugs, and other products. The first publicly traded company to be based on intellectual property developed at UMDNJ, it utilizes a structure called a cochleate which is a spiral, "jelly-roll" shape. The cochleate facilitates the delivery of therapeutics that normally require injection. As the next step in testing the new HIV therapy, BDSI is applying to the FDA to conduct a phase one clinical trial involving a larger number of patients.