About a year since the WHV138 trial initiation, the fourth and final vaccination was recently administered to the last volunteer of Group 1, marking a major milestone for WHV’s first phase 1b trial. Group 1 volunteers receive a co-administration of the polyvalent DNA/Protein HIV vaccine PDPHV over the course of 12 months, with the DNA and adjuvanted Protein vaccine injected intramuscularly in different arms at month 0, month 3, month 6 and month 12. This 4-dose vaccination regimen uses one dose less than the 5-dose vaccination regimen previously tested in the phase 1a trial HVTN124, in which the 5 doses were completed over the course of 8 months instead of 12. By comparing HVTN124 with WHV138, researchers are trying to assess if volunteers in WHV138 can achieve the same high level immunogenicity responses as observed in HVTN124.
Following their final vaccination, all actively enrolled volunteers are monitored for a 12-month follow-up period to ensure the safety of all study participants. The recent safety review conducted by the WHV138 Safety Monitoring Board did not identify any safety concerns.
WHV138 is a single-site randomized placebo-controlled phase 1b trial assessing the safety and immunogenicity of the second generation PDPHV, a polyvalent HIV vaccine candidate that originates from Dr. Lu’s lab at the University of Massachusetts Chan Medical School in Worcester, Massachusetts. This investigational vaccine has previously been tested under a different vaccination schedule using a DNA prime – protein boost approach in the phase 1a HVTN124 trial, which was sponsored by the HIV Vaccine Trials Network (HVTN) and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
Analyses from the preceding trial HVTN124 have shown excellent safety results and very promising immunogenicity data – remarkable findings that will be published soon.
