WHV is excited to announce that we are approaching the end of our phase 1b WHV138 trial as all Group 1 participants have now completed their scheduled visits and the remaining Group 2 participants continue the study until their final 12-month follow-up visit, with the last volunteer’s last visit to be expected by December of this year.
Overall, the safety profile of the vaccine candidate PDPHV looks excellent. The trial has passed all three SMB safety reviews without any concerns. Immunogenicity studies will be performed after the trial is fully completed, but preliminary analyses look very promising and reflect the remarkable immunogenicity data from the previous HVTN124 trial – the phase 1a trial testing PDPHV under a slightly different vaccination regimen. Results from that study will be published in the near future.
The second generation PDPHV is a polyvalent HIV vaccine candidate with two main components: a 5-plasmid DNA vaccine (ENV clades A, B, C, and AE and gag-C) and a recombinant quadrivalent gp120 Protein vaccine with antigens matched to the DNA vaccine. These two components have been investigated as a DNA prime/Protein boost regimen in HVTN124 and co-administered together both with and without adjuvant in WHV138. The forthcoming phase 2a trial will further explore the best form of regimen, vaccination schedule and dosing.
WHV138 is currently the only in-human trial investigating a vaccine candidate targeting viral ENV antigens from the four major circulating HIV-1 subtypes. Based on the results from HVTN124, we believe that PDPHV has the potential to be a globally relevant HIV vaccine candidate.
