More than 50 Nipah survivors are set to take part in the research, which is being backed by nearly $1m from the Coalition for Epidemic Preparedness Innovations (CEPI) and led by icddr,b (formerly known as International Centre for Diarrhoeal Disease Research, Bangladesh).
Nipah is one of the deadliest infections known to infect humans, with a case fatality rate estimated at 40-70%, but there are currently no vaccines licensed for use. CEPI also notes that a future virus within the same Paramyxovirus family could have pandemic potential.
Research will help Phase II Nipah vaccine trials
The study will take place in Bangladesh, where outbreaks of the deadly virus have occurred on an annual basis since the start of the twenty-first century.
“Securing this novel information could provide crucial input to guide the development of tools like diagnostic tests, treatments, and vaccines,” notes CEPI.
In addition to advancing scientific understanding of the virus, the biological material donated by the survivors will be used to support the development of key research tools, like assays and antibody standards, needed for upcoming Phase II clinical trials of Nipah vaccines, currently scheduled to start later this year.
CEPI has to date invested up to $100m in four Nipah candidates being developed by teams across academia and industry: Auro Vaccines and PATH, Public Health Vaccines (US), the University of Tokyo, and the University of Oxford.
Vaccines developed by Auro Vaccines and Public Health Vaccines are the first in the world to reach clinical trials.
Auro Vaccines LLC, a wholly owned indirect subsidiary of India’s Aurobindo Pharma Ltd, has developed HeV-sG-V: a Nipah vaccine candidate which is a recombinant subunit vaccine that contains a portion of the G glycoprotein of Hendra virus, a henipavirus closely related to Nipah. It entered Phase 1 studies in March 2020.
Public Health Vaccines, LLC (PHV), a biotechnology company out of Cambridge, MA, started its Phase 1 Nipah vaccine clinical trial in February this year.
The trial is evaluating 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.
The assays and antibody standards—developed in coordination with scientists at the UK Medicines and Healthcare products Regulatory Agency (MHRA) with expertise in biological standards—will be made available to both CEPI-funded and other Nipah vaccine developers to progress their programmes.
“These tools are set to play a major role in supporting future regulatory review of Nipah vaccines, especially when late-stage efficacy trials may be difficult to conduct due to the sporadic nature of outbreaks,” notes CEPI.
CEPI funding will also support the construction of local laboratory capacity in Bangladesh to prepare for clinical trials and new outbreaks of Nipah or other emerging infectious diseases.
Findings generated through the research will be shared through open-access publications and via scientific meetings with vaccine developers (including both CEPI-funded and non-CEPI funded developers).
A member of the Paramyxovirus family, the Nipah virus is spread to people by interaction with Pteropus bats (flying foxes)—the natural hosts of the virus—as well as infected pigs, infected humans, or through contaminated food like bat-bitten fruit or date palm sap.
It causes rapidly progressive illness, affecting the respiratory system and the central nervous system, and has a case fatality rate estimated at 40 to 75%.
Since its identification in 1998/1999 in Malaysia and Singapore, the virus has gone on to result in sporadic and unpredictable outbreaks in Bangladesh, India, and the Philippines – a region spanning thousands of kilometers. However, Pteropus bats are found across regions of Africa, South Asia and Oceania that are home to more than two billion people.