GeoVax Labs, Inc., announced today that early results from part A of an ongoing phase 2a clinical trial indicate an excellent safety profile and highly reproducible immunogenicity. The phase 2a trial is testing two recombinant DNA-vectored vaccine inoculations; the first at week 0 and the second at week 8, followed by two recombinant MVA-vectored vaccine inoculations, at weeks 16 and 24. The still-blinded data for 180 trial participants, enrolled at a ratio of two vaccine recipients for each placebo, reveal no safety concerns. These results are very similar to those observed in the Phase 1 trial. The trial, designated HVTN 205, is being conducted 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.
Of particular interest are assay results measuring vaccine-induced cellular (T-cell) immune responses, which are available for 128 of the participants. These tests revealed cellular immune response rates similar to those observed in the Phase 1 trial. Additional testing is ongoing to measure antibody responses and to further characterize cellular immune responses. Data will continue to be accumulated as the trial is completed.
"The high level of safety was expected" said Dr. Harriet Robinson, Chief Scientific Officer of GeoVax, "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."