WHV is preparing to file a new IND for PDPHV, its investigational DNA-prime/protein-boost vaccine. PDPHV is comprised of five DNA plasmids and four gp120 recombinant proteins and is being tested in a Phase I clinical trial (HVTN 124) as a prime-boost regimen or co-administered in repeated doses, in healthy adult volunteers. Results of the HVTN 124 trial are expected in early/mid 2020. If the vaccine is proven safe and immunogenic, the IND will allow WHV to rapidly advance PDPHV through to Phase IIa clinical testing.
The National Institutes of Allergy and Infectious Diseases (NIAID) holds the current IND for the vaccine candidate and NIAID-supported HVTN is running the Phase I HVTN 124 trial. WHV will work with NIAID, the U.S. FDA, and other regulatory partners to clarify the regulatory pathway for PDPHV.
For more information on the HVTN124 trial, please visit HVTN 124 Trial.
