As the recruitment of WHV 138 of Group 1 was recently completed with the enrollment of the 21st study participant, the clinical team resumes the recruitment of the phase 1b trial and started screening patients for Group 2. The vaccination regimen of Group 2 differs from the first group in that Group 2 participants will receive five vaccinations as opposed to four, but over the course of eight months instead of twelve months. While the investigational HIV vaccine candidate PDPHV is the same for both groups, Group 1 participants receive the DNA and Protein vaccine products separately in two different arms – the protein vaccine admixed with the adjuvant GLA-SE, while participants of Group 2 receive a DNA+Protein mix without the adjuvant.
WHV 138 is a phase 1b randomized double-blinded placebo-controlled trial evaluating the safety and immunogenicity of the polyvalent DNA/Protein HIV Vaccine (PDPHV) candidate, the first and only vaccine formulation tested in clinical trials that includes viral ENV antigens from all four major circulating HIV clades A, B, C, and AE. This product was previously tested in the HVTN 124 phase 1a trial and has shown excellent safety and immunogenicity results. It is now tested WHV 138 with a simplified vaccination regimen and will further be tested in a phase 2 trial to finalize the design of vaccine dosing and scheduling.
