GeoVax yesterday announced positive news of its ongoing phase IIa clinical trial being designated by the HIV Vaccine Trials Network (HVTN), which is funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health.
Early trial results demonstrate an “excellent” safety profile and highly reproducible immunogenicity regarding the company’s two recombinant DNA-vectored vaccine inoculations.
The still-blinded data involved 180 trial participants; participants were enrolled and administered a ratio of two vaccine recipients for each placebo; the study so far reveals no safety concerns. These results are very similar to those observed in the phase I trial.
Dr. Harriet Robinson, chief scientific officer of GeoVax, said while the company expected high safety rates, the results are still well received.
“The high level of safety was expected,” Dr. Robinson stated in the press release, “because of the excellent tolerability of recombinant DNA and recombinant MVA vaccine vectors in humans in our, as well as other prior trials. The apparent reproducibility of vaccine immunogenicity is very encouraging. The immunogenicity data not only indicate that our vaccine products are functioning as designed but also demonstrate the capabilities of the central HVTN laboratory whose scientists have developed and validated the assays that are so critical to clinical vaccine testing.”
The company said it is particularly focused on assay results measuring vaccine-induced cellular (T-cell) immune responses, which are available for 128 of the participants. These tests demonstrated cellular immune response rates similar to those observed in the phase II trial, and the company will conduct additional testing to further characterize cellular immune responses.
GeoVax is a biotechnology company focused on developing human vaccines for diseases caused by HIV and other infectious agents.
For more information visit www.geovax.com