Following its "allowed to proceed" notice, the NIH-funded HIV Vaccine Trials Network (HVTN) has started enrollment of GeoVax's second-generation HIV vaccine. The trial will include 48 people at four sites in the U.S., 40 receiving the vaccine at increasing doses and 8 as controls, and will check the safety of the vaccine, as well as look out for an immune response.
The DNA-based vaccine expresses the same HIV proteins as the first-generation vaccine, which is currently in Phase IIa, but carries its own adjuvant in the form of DNA expressing granulocyte-macrophage colony-stimulating factor (GM-CSF).
"We are extremely pleased the HVTN is conducting the trial with the adjuvanted vaccine. They have substantial experience with our unadjuvanted vaccine and possess appropriate expertise for this first human trial of our GM-CSF co-expressing vaccine that has shown such good promise in preclinical studies," Robert McNally, Ph.D., president and CEO of GeoVax, said.
The vaccine is given in two steps--two shots of the HIV/GM-CSF DNA vaccine to stimulate the immune system and trigger antibodies against the virus, followed by two booster shots of MVA, a recombinant poxvirus expressing HIV proteins. In animal studies, the vaccine protected 5 out of 7 animals from infection. If this study is successful, the company will move this form of the vaccine into Phase IIa/IIb trials.
- read the press release