Serum - Protection from birth onwards
Friday 24th July, Oxford - The University of Oxford’s Oxford Vaccine Group has successfully vaccinated the first volunteer in the world’s first clinical trial of a vaccine designed to protect against Bundibugyo ebolavirus (BDBV).
The milestone comes just weeks after the launch of the BD-Ebov study and marks the first time the ChAdOx1 BDBV vaccine has been administered to humans.
The ChAdOx1 BDBV vaccine was developed by scientists at the University of Oxford’s Oxford Vaccine Group and Pandemic Sciences Institute using the same vaccine technology as the Oxford/AstraZeneca COVID-19 vaccine, which is estimated to have saved around six million lives during its first year of use.
The speed of the programme has been enabled through a truly collaborative and global approach and is built on decades of vaccine manufacturing capabilities at the University's Clinical BioManufacturing Facility (CBF) and the Serum Institute of India (SII). SII manufactured ChAdOx1 BDBV vaccine in a record time and stockpiled 620,000 doses.
The study team will continue recruiting and vaccinating volunteers over the coming weeks while monitoring participants to assess both safety and immune responses generated by the vaccine.
The trial is supported by funding from the Coalition for Epidemic Preparedness Innovations (CEPI) as part of a US$8.6 million programme to the University of Oxford and SII to advance Bundibugyo vaccine development activities.
Dr David Pulido-Gomez, Global Chemistry, Manufacturing and Controls (CMC) lead, Pandemic Sciences Institute, Nuffield Department of Medicine, said, "Reaching this milestone in such a short timeframe reflects an extraordinary collaborative effort. Working alongside colleagues at the CBF and SII, we've taken this vaccine candidate from concept to clinic in just eight weeks."
Dr Peter Skydmore, Lead Study Doctor for the BD-Ebov trial at the Oxford Vaccine Group, said, "Vaccinating the first participants in a first-in-human study is always a significant moment. While these are very early days, they represent an important first step in evaluating this vaccine in humans. Over the coming months, we will continue vaccinating and monitoring participants, and assessing the safety and immune responses generated by the vaccine."
Katrina Pollock, Chief Investigator for the trial, said, "This is an important milestone for the trial, and marks the next phase in our multinational collaborative journey to develop a Bundibugyo ebolavirus vaccine. With the help of our many vaccine research partners and importantly, the clinical trial volunteers, our team will continue to work tirelessly in our response to this severe outbreak."
Professor Teresa Lambe OBE, Pandemic Sciences Institute and Oxford Vaccine group, said, "This latest step reflects the dedication of the general public and our volunteers in not only supporting but enabling a key response in the face of an ongoing and devastating outbreak. Their contribution is helping advance vaccine candidates into communities that need them most.
We are also grateful for the sustained support of our funders, including CEPI, NIHR, UKRI and to the MHRA for its rigorous and responsive oversight, which has enabled the rapid progression of this first-in-human study."
"With Bundibugyo cases increasing at a concerning rate in the DRC, this epidemic shows no signs of stopping. The need for a vaccine against this specific Ebolavirus becomes more urgent every day," said Dr Richard Hatchett, CEO of CEPI, the funders of this trial. "The rapid work of the Oxford team to begin early-stage testing of their vaccine is a much-needed step towards developing the tools that could help bring this outbreak to an end."
Mr. Adar Poonawalla, Chief Executive Officer, Serum Institute of India Pvt. Ltd. said, "The commencement of Phase I clinical trials for the ChAdOx1 BDBV vaccine is an encouraging milestone in the response to the current outbreak. We thank our partners for their dedication and shared commitment in advancing this programme at exceptional speed.
Manufacturing this vaccine candidate in record time and ensuring doses were available to support its clinical development demonstrates how preparedness, scientific innovation and scalable vaccine production can accelerate the development of solutions for emerging infectious diseases. We remain committed to supporting global efforts to improve equitable access to vaccines where they are needed most."
Subject to regulatory approval, preparations are also underway for further clinical studies of the vaccine with partners in Uganda.
If early-stage trials are successful, CEPI anticipates working with the University of Oxford and SII to support late-stage trials to generate data for emergency use authorisation or licensure
CEPI, SII and the University of Oxford are committed to enabling rapid, affordable supply of Bundibugyo virus vaccines to affected countries and to the populations that need them.
SII has manufactured and stockpiled approximately 620,000 doses of the ChAdOx1 BDBV vaccine within two weeks for potential future use and has supplied 4,000 investigational doses for this trial.
Find out more about the University of Oxford’s response to the Bundibugyo ebolavirus outbreak.
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NOTES FOR EDITORS
For more information about Ebola viruses or Ebola vaccines, visit OVG’s Vaccine Knowledge website: vaccineknowledge.ox.ac.uk/ebola-vaccine
For media requests, please email: news.office@admin.ox.ac.uk
The Oxford Vaccine Group
The Oxford Vaccine Group is part of the Department of Paediatrics at the University of Oxford. It led the rapid clinical development of vaccinations against COVID-19 in the pandemic and has made significant contributions to knowledge, supporting national and global policy on immunisation over three decades. OVG was founded in 1994 by Professor E. Richard Moxon. It is one of the world’s leading academic vaccine research teams, and has been led by Professor Sir Andrew Pollard since 2001. The OVG undertakes vaccine research spanning basic science and preclinical studies through to epidemiological studies, human challenge models and phase I-III clinical trials. Current research includes the study of vaccines for outbreak pathogens and pandemics, enteric pathogens, bacterial and viral respiratory infections, and use of human challenge models to accelerate vaccine development. www.ovg.ox.ac.uk
The Pandemic Sciences Institute
Institute is an interdisciplinary research institute at the University of Oxford dedicated to confronting the challenge of epidemic and pandemic infectious diseases. We work with academia, industry and public health organisations across the world to create science-led innovations, accelerate understanding, and develop new diagnostics, treatments, vaccines and disease control tools. PSI is hosted by the University’s Nuffield Department of Medicine. www.psi.ox.ac.uk
The University of Oxford
The University of Oxford has been ranked number 1 in the Times Higher Education World University Rankings for the ninth year running, and number 3 in the QS World Rankings 2024. At the heart of this success are the twin-pillars of our ground-breaking research and innovation and our distinctive educational offer. Oxford is world-famous for research and teaching excellence and home to some of the most talented people from across the globe. Our work helps the lives of millions, solving real-world problems through a huge network of partnerships and collaborations. The breadth and interdisciplinary nature of our research alongside our personalised approach to teaching sparks imaginative and inventive insights and solutions. www.ox.ac.uk
CEPI
CEPI is an innovative partnership between public, private, philanthropic and civil organisations. Its mission is to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic threats so they can be accessible to all people in need. Central to CEPI’s pandemic-beating plan is the ‘100 Days Mission’ to develop safe, effective and accessible vaccines against new threats in just 100 days. CEPI is seeking $2.5 billion to execute CEPI 3.0, its 2027-2031 strategy which will systematically reduce the likelihood, impact and cost of epidemics and pandemics by driving the 100 Days Mission towards an operational reality. Learn more at CEPI.net
Serum Institute of India Pvt. Ltd.
Serum Institute of India Pvt. Ltd., part of Cyrus Poonawalla Group is a global leader in vaccine manufacturing, dedicated to providing affordable vaccines worldwide. Present across 170+ countries, including the US, UK, and Europe, SII holds the distinction of being the world’s largest vaccine manufacturer. SIIPL’s multifunctional production and one-of-the-largest facilities in Hadapsar & Manjari, Pune, with an annual capacity of 4 billion doses, has saved over 30 million lives over the years.
Founded in 1966, SIIPL’s primary mission is to produce life-saving immunobiological drugs, with a particular emphasis on affordability and accessibility. Guided by a strong commitment to improving global health, the company has played a pivotal role in reducing the prices of essential vaccines, such as Diphtheria, Tetanus, Pertussis, HIB, BCG, r-Hepatitis B, Measles, Mumps, and Rubella. Notably, they are the manufacturers of ‘Pneumosiil,’ the world’s most affordable PCV, ‘Cervavac’ the first indigenous qHPV vaccine in India, and R21/Matrix-M™, the second Malaria vaccine to be authorized for use in children in malaria-endemic regions, ‘MenFive’, the first in the world Pentavalent (ACYWX) Meningococcal Polysaccharide Conjugate Vaccine, approved and WHO-prequalified for use in the pediatric and adult population. Moreover, SIIPL has been at the forefront of the global fight against COVID-19, delivering over 2 billion doses of the COVID-19 vaccine worldwide.
To further expand its global presence and ensure widespread vaccine availability, SII has established Serum Life Sciences Ltd, a subsidiary in the UK and Serum Inc., a subsidiary in the US. Through relentless pursuit of innovation, SII continues to champion the cause of affordable vaccines, making a positive impact on the lives of millions worldwide.
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