Worcester HIV Vaccine (WHV) is happy to announce that the phase 1b clinical trial WHV138, evaluating the safety and immunogenicity of the vaccine product PDPHV-21401, has started screening last week with anticipated enrollment of the first patient this week.
WHV138 is a single-site clinical trial conducted at Brigham and Women’s Hospital, a teaching affiliate of Harvard Medical School in Boston, MA, and is building onto the positive results of the recently finished phase 1a HVTN124 trial that was managed by the HIV Vaccine Trial Network (HVTN). The phase 1b trial will further investigate the polyvalent DNA/gp120 vaccine candidate with a simplified administration schedule. WHV138 differs from the HVTN124 protocol in that the vaccine product will now be tested using a co-delivery regimen as opposed to a DNA prime – Protein boost approach. In particular, the study will explore two different simplified approaches: one with a reduced number of vaccinations by co-administering the DNA and the Protein/adjuvant GLA-SE products at the same time but in different arms; the other approach uses a mixture of DNA and Protein vaccines, omitting the use of GLA-SE.
“We are excited to start this clinical trial to investigate the development of a potential HIV vaccine relevant for global health,” said Stephen Walsh, MD, Principal Investigator of WHV138 and a physician in the Division of Infectious Diseases at Brigham and Women’s Hospital.
It is the first US FDA approved Investigational New Drug (IND) application for WHV, the sponsor of the clinical trial, allowing WHV to quickly advance the novel vaccine candidate PDPHV-21401 through their recently established product development program. This is truly a major milestone for WHV since the biotechnology company was only founded three years ago by licensing the HIV vaccine technology from Professor Shan Lu’s laboratory at the University of Massachusetts Medical School.
“We are thrilled to see the fast progress of our HIV vaccine candidate PDPHV managed by WHV,” said Dr. Shan Lu.
The clinical research organization Target Health, LLC, was responsible for the IND filing for WHV and will provide monitoring service for the WHV138 trial. Waisman Biomanufacturing, a contract manufacturing organization based in Wisconsin, performed GMP manufacturing service for the polyvalent DNA/gp120 vaccine to be used in WHV138. The adjuvant GLA-SE, used in the current formulation, was provided by IDRI in Seattle. Detailed design of WHV138 can be found at clinicaltrials.gov.
