GeoVax Labs, a biotechnology company developing human vaccines, announced today the filing of an Investigational New Drug (IND) application with the FDA for the conduct of the next human clinical trial of GeoVax's preventive HIV vaccine. The IND was filed by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
The phase I trial (designated HVTN 114) will be conducted by the NIAID-supported HIV Vaccine Trials Network (HVTN). The company expects HVTN 114 to begin enrolling patients in September 2016.
HVTN 114 will enroll up to 100 individuals who participated in the HVTN 205 phase IIa trial of the GOVX-B11 vaccine (concluded in 2012) and will test the ability of late boosts to increase the antibody responses elicited by the GeoVax vaccine. The late boosts will consist of the GeoVax MVA62B vaccine with or without a gp120 protein vaccine. The gp120 protein, AIDSVAX B/E, will be supplied by Global Solutions for Infectious Diseases (GSID). Eligible participants in HVTN 114 will receive either (a) another MVA62B boost, (b) a combined boost of MVA62B and AIDSVAX B/E, or (c) AIDSVAX B/E alone.
Harriet L. Robinson, Ph.D., GeoVax's chief scientific officer, said, "HVTN 114 represents the first clinical study of the effect of late boosts, which include a protein boost on the GOVX-B11 DNA/MVA vaccine. The protein boost, AIDSVAX B/E, is the same protein used to boost immune responses in the partially successful RV144 trial in Thailand. AIDSVAX B/E is being used to gain an initial assessment of the effect of late boosts of GOVX-B11 while new proteins are being cGMP manufactured for future use."
The HVTN is the largest worldwide clinical trials network dedicated to the development and testing of preventive HIV/AIDS vaccines. The HVTN is an international collaboration that conducts all phases of clinical trials, from evaluating experimental vaccines for safety and the ability to stimulate immune responses, to testing vaccine efficacy. Support for the HVTN comes from NIAID. The Network's HIV Vaccine Trial Units are located at leading research institutions in 27 cities on four continents. The Network's headquarters are at the Fred Hutchinson Cancer Research Center in Seattle, Washington.