GenVec's HIV vacc enters Ph I trial

US gene-based vaccines and therapeutics firm GenVec says that the Vaccine Research Center of the National Institute of Allergy and Infectious Diseases has begun a Phase I clinical trial to test Ad35HIV-EnvA, its novel vaccine to prevent HIV-1 infection. The adenovector-based vaccine was developed under a collaborative R&D agreement with the VRC.

The two-part Phase I study is designed to evaluate the safety, tolerability and immunogenicity of the Ad35-EnvA vaccine in comparison to and in combination with the Ad5-EnvA vaccine in prime-boost schedules. The first part of the program, a dose-escalation evaluation, will enroll 15 healthy adult volunteers. Three groups of five subjects will each receive one intramuscular injection of the vaccine at three different doses. Following vaccination of each cohort, an internal safety review will be conducted. The second phase of the study is designed to test prime-boost combinations of Ad5- and Ad35-based vaccines, GenVec noted.