Cambridge, Massachusetts company, Public Health Vaccines, LLC announced today the start of its Phase 1 clinical trial to evaluate the safety and immunogenicity of the company’s single-dose vaccine (PHV02) against Nipah virus.
The PHV02 vaccine is a live, attenuated, recombinant vesicular stomatitis virus (rVSV) vector that expresses the glycoprotein of the Nipah virus (Bangladesh strain) and the Ebola virus glycoprotein, which is required for receptor-mediated viral entry. The rVSV-Nipah vaccine was developed by the Laboratory of Dr. Heinz Feldmann within the Laboratory of Virology, Division of Intramural Research, National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and has been licensed to PHV by NIAID. PHV has been developing the vaccine in partnership with the Coalition for Epidemic Preparedness and Innovations (CEPI) under and award of up to US$43.6 million that facilitates development through Phase 2 clinical trials, including supportive non-clinical and manufacturing activities.
Joan Fusco, PHV’s Chief Operating Officer, commented, “We are very thankful for CEPI’s ongoing support that has resulted in this first-in-human clinical testing of our single dose Nipah vaccine. This marks a significant inflection point for the program achieved by our outstanding team and its deliberate approach to product development. The lessons learned from the ongoing pandemic reinforce the continued risk of other emergent pandemic threats. Being prepared with medical interventions is paramount to an effective, non-disruptive public health response. Our mission continues as we develop vaccines to confront these unmet medical needs with our Nipah vaccine leading that arsenal.”
“Our teams working together at PHV and Crozet BioPharma to develop the PHV02 Nipah vaccine also helped to advance the similar recombinant VSV vaccine against Ebola which is now approved for use”, noted PHV Senior Advisor Dr. Thomas Monath (Crozet BioPharma). “The Phase 1 trial of PHV02 will provide the first evaluation of safety, tolerability and dose response of the live, attenuated vaccine in humans, and will determine whether humans mount antibodies neutralizing Nipah virus similar to those found to be solidly protective against illness and death in various animal models.”
The Phase 1 clinical trial is a randomized, double blind, placebo controlled, single center, dose response study designed to evaluate the safety, tolerability and immunogenicity of three dose levels of PHV02 in 60 healthy adults in the U.S. Assuming favorable results PHV plans to initiate a Phase 2 trial in 2022 in a disease endemic region.