In less than 4 months since the start of the WHV138 trial, the clinical team enrolled 21 healthy volunteers into the study and thus completed the enrollment objective of the first of two groups. Now that Group 1 is fully enrolled, the clinical team will continue their screening efforts and start enrollment of Group 2 soon, anticipating to fully enroll the whole study by early 2022.
WHV138 is a phase 1b single site randomized placebo-controlled trial evaluating the safety and immunogenicity of the polyvalent DNA/Protein HIV vaccine product PDPHV, which is tested in two groups receiving two different vaccine regimens. Group 1 receives the DNA and Protein+adjuvant vaccines injected separately in each upper arm; 4 doses are given over the course of 12 months. Group 2 will receive the DNA and Protein products mixed together without the inclusion of an adjuvant; 5 doses are given over the course of 8 months. Both groups will be followed up for an additional 12 months to monitor the safety profile of the PDPHV product.
The PDPHV vaccine candidate consists of two components, a 5-plasmid DNA vaccine covering the HIV clades A, B, C, and AE, and a 4-valent recombinant gp120 protein vaccine, matched to the DNA plasmids. PDPHV is the first and only vaccine formulation tested in clinical trials that includes viral ENV antigens from all four major circulating HIV clades, presenting a vaccine candidate that could have a significant impact on the global HIV burden. This product was previously tested in the HVTN124 phase 1a trial and has shown excellent safety and immunogenicity results. It is now tested with a revised vaccination regimen and will further be tested in a phase 2 trial to finalize the design of vaccine dosing and scheduling.
