Working with Waisman Biomanufacturing, WHV scientists manufactured a novel 4-valent gp120 protein vaccine for further clinical testing of its preventive HIV vaccine candidate PDPHV.
Previously, the laboratory of Dr. Shan Lu at the University of Massachusetts Medical School (UMMS) developed the polyvalent HIV vaccine including both DNA and protein components. In recently conducted phase I clinical trial HVTN124 supported by US NIH/NIAID, four gp120 proteins from the four major clades of HIV-1 (A, B, C, and AE) were individually vialed. The proteins had to be mixed with each other and with the GLA-SE adjuvant at bedside prior to administration.
Recently, WHV has launched a major program to establish the production of a final drug product with 4 gp120 proteins mixed in the same vial. Extensive pilot tests were conducted to ensure the proteins can be formulated together and characterized using existing and new analytical assays. WHV consulted with US FDA and received confirmation on its plans to ensure the quality of this novel product.
Now for the first time in the history of HIV vaccine development, four highly purified gp120 proteins were mixed in equal amounts to produce the 4-valent protein mixture, which was vialed to produce the final product to be used in the upcoming clinical trials.
This novel 4-valent formulation will greatly simplify storage, transportation, and administration of the protein vaccine. WHV recently produced a new batch of the 5-valent DNA component of the vaccine using the updated manufacturing process. Having both DNA and protein vaccine components positions WHV for rapid advancement toward the next stages of clinical testing of the PDPHV vaccine candidate.
