In preparation for IND submission, WHV requested FDA’s opinion on its approach to manufacturing protein and DNA vaccines for the planned Phase 2a clinical trial. The request included plans for improved plasmid DNA production, advancement of protein vaccine formulation, and corresponding changes to analytical assays that will be used to release the vaccine for clinical studies.
The response from FDA experts was generally positive and did not identify any major challenges to the proposed improvements in the GMP manufacturing process and testing of WHV’s vaccine components. This confirmation clears the path for advancing WHV’s vaccine candidate PDPHV to the next stage of clinical testing.
Currently, PDPHV candidate is being tested in HVTN 124, a Phase I clinical trial run by HIV Vaccine Trials Network, based in Seattle and funded by the National Institute of Allergy and Infectious Diseases. WHV recently announced its commitment to launching a Phase 2a trial to optimize the immunization approach and to further characterize the safety and immunogenicity of its vaccine candidate.
