Nipah Virus Vaccine (PHV02) 2023
The Nipah Virus Vaccine (PHV02) is a live, attenuated, recombinant vesicular stomatitis virus (rVSV) vector vaccine candidate 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 U.S. NIH, and has been licensed to Public Health Vaccines by the NIAID.
Public Health Vaccines (PHV) has been developing the rVSV∆G-EBOV GP/NiV G vaccine candidate in partnership with the Coalition for Epidemic Preparedness and Innovations (CEPI) under an award of up to US$43.6 million that facilitates development through Phase 2 clinical trials, including supportive non-clinical and manufacturing activities. A Phase 1 clinical study evaluating the rVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects was last updated on April 20, 2022.
Nipah virus has caused outbreaks in Bangladesh since 2001 and occasionally in neighboring India, Singapore, and the Philippines.
Public Health Vaccines, LLC. (PHV), headquartered in Cambridge, Massachusetts, is a privately-held biotechnology company developing products to prevent and control emerging infectious diseases. The company initially focused on creating vaccines against the Marburg virus and Sudan ebolavirus utilizing the rVSV platform in collaboration with the Biomedical Advanced Research and Development Authority (BARDA).
Nipah Virus Overview
Nipah virus is a paramyxovirus whose wildlife reservoir is the fruit bat (genus Pteropus). Characteristics of Nipah virus infection that increase the risk of engendering a global pandemic include the susceptibility of humans and the high rate of mutation, which is inherent in RNA viruses. Together, these characteristics could support the emergence of a human-adapted strain capable of spreading rapidly by infecting communities with high population density and global interconnectedness.
Nipah Virus Vaccine (PHV02) News 2023
February 17, 2023 - The WHO announced that since 4 January 2023 and as of 13 February 2023, 11 cases (10 confirmed and one probable), including eight deaths (Case Fatality Rate 73%), have been reported across two divisions in Bangladesh.
March 15, 2022 - CEPI is expanding its partnership in Bangladesh, providing near to an additional $1 million in funding to advance understanding of the Nipah virus.
March 14, 2022 - PNAS published a Research Article: A recombinant VSV-vectored vaccine rapidly protects nonhuman primates against lethal Nipah virus disease.
February 9, 2022 - Public Health Vaccines, LLC announced the start of its Phase 1 clinical trial to evaluate the safety and immunogenicity of the company’s single-dose vaccine (PHV02) against the Nipah virus.
November 5, 2021 - CEPI published an article: Nipah virus: The deadly illness without a vaccine.
April 23, 2021 - GAVI, the vaccine alliance, examined the possibility of the Nipah virus causing another pandemic someday. The primary concern is that the Nipah virus is deadly, with up to a 75% mortality rate.
January 2021 - This study provides molecular and methodological information for the early detection of NiV in environmental samples to assess its epidemic potential in humans. It will also help in understanding the ecology of NiV. And the study revealed that the strains of NiV have been continuously evolving, and the NiV-BD genotype diverged from its ancestral during 1995 and formed two sublineages, NiV-BD 1 and 2. Furthermore, the occurrence of any particular sublineage of NiV strains was not limited to a specific outbreak region.
Nipah Virus Vaccine (PHV02) Clinical Trials
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.
