GeoVax Labs, www.geovax.com – the leading developer of vaccines for diseases linked to HIV and other infectious agents, reported today excellent results from part A of ongoing phase 2a clinical trials utilizing a sequence of two recombinant DNA-vectored inoculations followed up by two recombinant MVA-vectored inoculations.
The trial thus far has shown exceptional safety characteristics, further confirmed by readily reproducible immunogenicity targets.
The inoculation schedule consists of four intervals separated by eight weeks each and the still-blinded data generated thus far from the pool of 180 participants (ratio of two vaccines per placebo) indicates that there are no valid/salient safety concerns.
Incredible news for GOVX and its shareholders, as this data echoes results obtained from previous Phase 1 trials.
The trial for these vaccine inoculations is being administrated by the HIV Vaccine Trials Network (thus the HVTN 205 designation), funded by U.S. National Institutes of Health agency, the National Institute of Allergy and Infectious Diseases.
CEO of GOVX, Dr. Harriet Robinson, noted the key nature of vaccine-induced T-cell immune responses indicated by assay results from 128 of the participants, which mirrored Phase 1 results.
With additional testing underway to further validate this excellent safety/efficacy profile by measuring antibody responses and generating the data necessary to afford a clearer picture of overall cellular immune responses, GOVX stands poised to realize a substantial breakthrough.
As data continues to come in during the progress of the trial, Robinson feels certain that the high level of safety, which had been projected by GOVX early on, will achieve further verification.
The excellent tolerability of recombinant DNA/MVA vaccine vectors demonstrated thus far (and in other, prior trials) is a strong indicator that the apparent reproducibility of vaccine immunogenicity is accompanied by a safety profile which makes the product very promising.
Not only does the immunogenicity data confirm the vaccine product design parameters, according to Robinson, it also directly substantiates the capabilities of the central HVTN laboratory “whose scientists have developed and validated the assays that are so critical to clinical vaccine testing”.