The WHV138 Safety Monitoring Board recently held their third periodic safety review meeting and concluded that the investigational HIV vaccine candidate PDPHV does not present any safety concerns to the trial participants. The trial can thus continue as planned without any modification.
This was the last scheduled safety review meeting for WHV’s phase 1b trial, which is already in its final stage: All active volunteers have completed their vaccination visits and are within their 12-month observation period. About a third of the Group 1 participants have already finished the trial with their final study visit. The last volunteer’s last visit is expected to take place towards the end of this year. Blood samples for immunogenicity studies are collected through the final study visit to allow for longevity analyses of the induced immune responses up until 12 months after final vaccination.
WHV’s second-generation HIV vaccine candidate PDPHV includes a 5-pladmid DNA vaccine component with a matched quadrivalent gp120 Protein vaccine component and is currently the only vaccine formulation targeting viral ENV antigens from all four major circulating HIV subtypes. With such a low-risk safety profile and promising immunogenicity results, WHV is excited to be moving PDPHV through the subsequent product development stages as the phase 1b trial WHV138 is coming to an end.
