University of Oxford Launches World's First Phase II Nipah Virus Vaccine Trial in Bangladesh
Key Insights
The University of Oxford has initiated the world's first Phase II clinical trial of a Nipah virus (search) vaccine candidate in Bangladesh, marking a critical milestone in pandemic preparedness efforts.
The ChAdOx1 NipahB vaccine (search) trial will enroll 306 healthy participants aged 18-55 to assess safety and immune response in a region experiencing regular Nipah outbreaks.
Nipah virus (search) poses a severe public health threat with a case fatality rate of up to 75% and is recognized by WHO as a priority pathogen with pandemic potential.
The University of Oxford has launched the world's first Phase II clinical trial of a Nipah virus (search) vaccine candidate, representing a significant advancement in global pandemic preparedness. The trial, conducted in Bangladesh through a partnership with the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), began earlier this month and will evaluate the ChAdOx1 NipahB vaccine (search) in a population regularly exposed to Nipah virus outbreaks.
Critical Need for Nipah Virus Protection
Nipah virus (search) presents a formidable public health challenge, with a case fatality rate reaching up to 75%. The World Health Organization has classified it as a priority pathogen with pandemic potential, underscoring the urgent need for effective countermeasures. Since its first identification following an outbreak in Malaysia, the virus has caused 750 recorded cases globally since 1998, resulting in 415 deaths.
The zoonotic virus, carried by fruit bats and belonging to the same paramyxovirus family as measles, causes small but deadly outbreaks in Bangladesh almost annually, with occasional cases in India. Transmission occurs primarily through consumption of contaminated date palm sap, though the virus can also spread through intermediate animal hosts or person-to-person contact, including to healthcare workers.
Trial Design and Vaccine Development
The Phase II trial will enroll 306 healthy participants aged 18 to 55, building on promising results from the first-in-human Phase I study conducted in Oxford. That initial trial, which began in January 2024, successfully enrolled 51 participants who have safely completed one year of follow-up, with results expected in the coming months.
The ChAdOx1 NipahB vaccine (search) leverages the same viral vector platform used in the Oxford/AstraZeneca COVID-19 vaccine, which is estimated to have saved 6 million lives in its first year. The vaccine was manufactured by the Serum Institute of India Pvt. Ltd., part of the Cyrus Poonawalla Group and the world's largest vaccine manufacturer.
Regulatory Recognition and International Collaboration
In recognition of the vaccine's potential and the urgent medical need, the European Medicines Agency (search) granted the ChAdOx1 NipahB vaccine (search) PRIME (PRIority MEdicines) designation in June 2025. This designation is designed to expedite development and regulatory review processes for medicines addressing significant unmet medical needs.
Professor Dame Sarah Gilbert, Professor of Vaccinology at the Pandemic Sciences Institute and the vaccine's developer, emphasized the importance of international collaboration: "This new trial in Bangladesh marks an important step forward in our work to develop a vaccine against Nipah virus (search), a deadly health threat that currently has no approved vaccine or treatment. The progress we've made so far – with the support of our collaborators and funders – is testament to the value of international collaboration and long-term investment in pandemic preparedness."
Strategic Location and Global Impact
The decision to conduct the Phase II trial in Bangladesh reflects the strategic importance of testing the vaccine in populations most at risk. Professor Brian Angus, Chief Investigator of the trial at the Oxford Vaccine Group, noted: "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."
Dr. K Zaman, Senior Scientist at icddr,b and Principal Investigator of the Bangladesh trial, highlighted the institution's unique position in Nipah research: "icddr,b has been at the forefront of Nipah virus (search) research for over two decades, operating the world's longest-running surveillance system and following the largest cohort of Nipah survivors."
Clinical Significance and Future Implications
The clinical presentation of Nipah virus (search) infection begins with symptoms including fever, headaches, muscle pain, vomiting, and sore throat, which can rapidly progress to acute encephalitis (search), pneumonia (search), and severe respiratory problems. The absence of approved vaccines or treatments makes this trial particularly significant for global health security.
Dr. Kent Kester, CEPI's Executive Director of Vaccine Research and Development, described the vaccine as "the most advanced vaccine against this highly lethal virus," noting that the Phase II trial represents "the culmination of years of cutting-edge research and global scientific collaboration."
The trial is funded by the Coalition for Epidemic Preparedness Innovations (search) (CEPI), which supports the development of vaccines against epidemic and pandemic threats as part of its mission to ensure global accessibility to life-saving countermeasures.