In preparation for further clinical testing of its PDPHV vaccine candidate, WHV is working closely with Dr. Shan Lu’s Laboratory of Nucleic Acid Vaccines (LNAV) at the University of Massachusetts Medical School to conduct immunogenicity studies of the vaccine in small animal models. The studies will test the immunogenicity of newly manufactured vaccine products for a planned Phase IIa study and help refine the design of the next clinical trials by exploring different vaccine formulation, dosing, and administration schedules.
Phase I clinical study HVTN 124 is testing safety and immunogenicity of WHV’s DNA-prime/protein-boost vaccine candidate PDPHV in healthy volunteers. The results of the trial will be available later this year, but WHV is already planning the next steps in its clinical program. Additional questions about vaccine formulation, dosing, and schedule will be answered in the follow-up clinical trials.
Testing in small animal models can be extremely helpful in down-selecting among many potential avenues of vaccine improvement. Because the PDPHV vaccine candidate has been developed at LNAV, the researchers there, including Drs. Shan Lu and Shixia Wang have extensive expertise in assessing immunogenicity of this vaccine in preclinical models. Several animal studies are being conducted to investigate immune responses to the current vaccine candidate, to help better interpret the expected results of the current HVTN 124 trial, and to bridge the findings to future clinical trials.
