WHV researchers showed that they can improve the manufacturing of the DNA component of their candidate HIV vaccine PDPHV to allow a faster and more effective path to Phase II clinical trials. These biomanufacturing advances have the potential to inform the way HIV vaccine candidates are manufactured in the future.
WHV researchers together with Waisman Biomanufacturing, a non-profit biomanufacturing partner, confirmed that by using DH5a, E. coli strain, with a proprietary technology, they can manufacture DNA plasmids that are purer and result in higher yields than previously thought. This development shows a more robust and effective approach to making the essential components of the PDPHV vaccine and could accelerate manufacturing of the candidate vaccine for future clinical trials and eventual manufacturing of the vaccine after its approval.
PDPHV is WHV’s investigational DNA-prime/protein-boost vaccine, which is comprised of five DNA plasmids and four gp120 recombinant proteins and is being tested as a prime-boost regimen or co-administered in repeated doses, in healthy adult volunteers.
Specifically, researchers completed manufacturing of five plasmid constructs for the DNA vaccine, which included the creation of new cell banks for all five plasmids. Plasmid constructs are essential because they make up the DNA prime component of the vaccine. This is an important step toward the planned Phase IIa trial of PDPHV and demonstrates a new level of advancement in biomanufacturing.
Historically, protein HIV vaccines have been poorly immunogenic because of a number of immune escape mechanisms deployed by the viral Env protein. Using a DNA delivery of HIV Env to prime the immune response ensures high magnitude and high quality of antibodies elicited by boosting with recombinant HIV Env proteins.
PDPHV is the first and only HIV vaccine candidate to use a multivalent approach with HIV Env proteins from the four major clades or strains of HIV. The PDPHV vaccine is currently being tested by the HIV Vaccine Trials Network (HVTN) in a Phase I clinical trial HVTN 124.
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