The Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine (MRC/UVRI & LSHTM Uganda Research Unit) has launched a Phase I clinical study to evaluate the safety and immunogenicity of a vaccine candidate against Bundibugyo Virus Disease (BVD), a severe disease caused by the Bundibugyo virus, a species of Ebola virus. The study aims to advance vaccine development against Ebola virus species for which no licensed vaccines are currently available.

The trial is being conducted in partnership with the Oxford Vaccine Group and Pandemic Sciences Institute at the University of Oxford. It will assess the safety of the ChAdOx1 BDBV vaccine candidate and its ability to stimulate an immune response in healthy adult volunteers.

Developed by scientists at the University of Oxford, the vaccine candidate’s viral seed stock was produced and quality-tested at the university’s Clinical Biomanufacturing Facility, providing the starting material for large-scale vaccine manufacturing.

Serum Institute of India (SII), based in Pune, has collaborated in the manufacturing and stockpiling of approximately 620,000 doses of the vaccine candidate within two weeks for potential future use. The company has supplied 300 vials to the UK and approximately 3,000 investigational doses for the Phase I trial in Uganda.

The Uganda study is led by Professor Eugene Ruzagira, Head of Clinical Research and Trials at the MRC/UVRI & LSHTM Uganda Research Unit. The trial will take place at the Unit’s clinical research site in Masaka City, southwestern Uganda. The site has more than three decades of experience in vaccine research and clinical trials, supported by clinical and laboratory infrastructure and established community partnerships.

The Coalition for Epidemic Preparedness Innovations (CEPI), SII and the University of Oxford are working to support the rapid and affordable supply of Bundibugyo virus vaccines to affected countries and populations that need them.

Bundibugyo virus was first identified during an outbreak in western Uganda in 2007. The absence of a licensed vaccine against the virus makes vaccine development an important priority for global epidemic preparedness. The Phase I study also builds on the Uganda Research Unit’s work on emerging infectious diseases and Uganda’s participation in international efforts to develop vaccines and other interventions against epidemic-prone diseases.

Dr. Umesh Shaligram, Executive Director of Serum Institute of India, said the initiation of the Phase I study marked an important step in addressing an unmet need in Ebola preparedness. He added that the rapid manufacture, stockpiling and supply of investigational doses demonstrated the role of international collaboration in advancing vaccine development. SII remains committed to contributing its manufacturing expertise to the development of vaccines against emerging infectious diseases.