Thanks to our highly experienced clinical team, the enrollment objective of a total of 42 study participants has been completed. With the recent enrollment of the 21st healthy volunteer into Group 2, the single-site WHV138 trial is now fully enrolled after 10 months of assiduous recruitment efforts. This marks a major milestone for the young biotech company WHV, who is a first-time IND holder and the sponsor of this phase 1b randomized, placebo-controlled trial.
As the vaccination regimen for Group 2 includes five vaccinations over the course of 8 months, the trial’s very last vaccination will be administered by late-December of this year, followed by a 12-month safety observation period. Thus, we can anticipate the entire trial to be completed before the end of 2023. So far, there have been no major safety concerns identified. Data analyses regarding the immunogenicity of the vaccine candidate PDPHV as used in WHV138 will follow and are expected to give additional insights into the very promising immunogenicity profile generated by the HVTN124 study – a previously conducted phase 1a trial testing PDPHV under a slightly different vaccination regimen.
PDPHV is currently the only vaccine formulation tested in humans that includes viral ENV antigens from all four major circulating HIV clades with the potential to elicit very promising immune responses without any major safety concerns. WHV is therefore eager to move their HIV vaccine candidate further through the next testing stages to explore vaccine efficacy. The team has already started to prepare for a larger scale study and is hoping to officially announce trial partners in the near future.
