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The University of Oxford has launched the world’s first Phase II clinical trial of a Nipah virus vaccine candidate in Bangladesh, which has been manufactured by the Pune-based Serum Institute of India (SII). A vaccine is urgently needed as the infection can be fatal in up to 75 per cent of cases.
The ChAdOx NipahB vaccine was manufactured for this clinical trial by the Serum Institute of India Pvt. Ltd. (SIIPL), part of Cyrus Poonawalla Group and the world’s largest vaccine manufacturer, in collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI).
The trial will enrol 306 healthy participants aged 18 to 55 and is being conducted in Bangladesh in partnership with the International Centre for Diarrhoeal Disease Research, Bangladesh. Developed by scientists at the University of Oxford’s Pandemic Sciences Institute, the first in human trials of the ChAdOx1 NipahB vaccine started in January 2024 in Oxford, led by the Oxford Vaccine Group. Fifty-one people aged 18 to 55 have safely completed one year of follow-up in the Oxford trial with results expected in the coming months.
What is Nipah?
Nipah virus is a deadly zoonotic disease with a case fatality rate of up to 75 per cent and is listed by the World Health Organization (WHO) as a priority pathogen with pandemic potential for research and development. First identified after an outbreak in Malaysia, Nipah virus causes small outbreaks in Bangladesh almost every year and occasionally in India. Of the 750 cases recorded since 1998, there have been 415 deaths.
The zoonotic virus is carried by fruit bats and its main route of transmission is through drinking contaminated date palm sap. Humans may also be infected via an intermediate animal host, or by person-to-person spread including healthcare workers. Initial symptoms include fever, headaches, muscle pain, vomiting and sore throat. These can quickly progress to acute encephalitis, pneumonia and severe respiratory problems.
Why is the trial significant?
The trial will assess the safety and immune response of the ChAdOx1 NipahB vaccine in a region where the virus causes recurrent outbreaks.
According to Prof Angus, starting a Phase II trial in a country affected by regular Nipah outbreaks is a critical step in making sure this vaccine is both effective and relevant to the people who need it most. “It’s an essential part of ensuring equitable access to protection against emerging infectious diseases,” he said.
How stable is the vaccine?
“Viral vector vaccines are much more heat-stable and so storage at +5 degrees for a few days has been shown to maintain potency. In fact, there is evidence of safety even when higher temperatures have been inadvertently exposed. This is one of the advantages of ChAdOx use in low-resource and outbreak settings. The rapid scalability of production is also an advantage, as thousands of doses can be manufactured within days,” Prof Angus said.
Dr Umesh Shaligram, Executive Director, Serum Institute of India, had earlier said that SII would manufacture doses for use in Phase II clinical trials. “The effort will be to create an investigational reserve of up to 100,000 doses, which could be deployed under emergency use during a future Nipah virus outbreak,” he had said.
