University of Pennsylvania School of Medicine researchers are recruiting healthy, HIV-negative adults to participate in a phase I clinical trial of an experimental HIV vaccine called PENNVAX-B, a DNA-based vaccine which is made using synthetic DNA-based HIV genes.
Approximately 120 trial participants will be divided into several vaccine groups to test the safety and immunogenicity of various cytokine “molecular adjuvants” that previous studies have shown to help boost immune response to the vaccine in monkeys.
“This study is unique in that it tests the ability of a novel DNA vaccine to tailor immune responses against the HIV pathogen using molecular adjuvants delivered in a plasmid form,” says David Weiner, PhD, a Penn professor of Pathology and Lab Medicine who developed the vaccine. “If successful, it will support future studies of this novel vaccine and be an important baseline for growth of this technology platform.”
The study, which also includes a site at the University of Alabama at Birmingham, is expected to last for two years. Researchers are seeking male and female participants in good health between the ages of 18 and 50 who are not infected with HIV or Hepatitis B or C. Each participant will be followed for 12 months. Those who have participated in a previous HIV vaccine trial are not eligible to participate, nor are those who have active syphilis, diabetes, some types of asthma and various other diseases. Women who are pregnant or nursing are also ineligible to participate.
The vaccine development and the clinical trial are sponsored by the Division of AIDS at the National Institute of Allergy and Infectious Diseases, the National Institutes of Health and the Department of Health and Human Services. The study is conducted under the HIV Vaccine Trials Network. Wyeth Pharmaceuticals is an industry partner for the vaccine.