Hilleman Laboratories is preparing to manufacture clinical-trial doses of an investigational vaccine against Bundibugyo virus, backed by up to $8.5m from the Coalition for Epidemic Preparedness Innovations (CEPI).
The Singapore-based joint venture between Merck and Wellcome will manufacture a single-dose recombinant vesicular stomatitis virus (rVSV) vaccine developed by the International AIDS Vaccine Initiative (IAVI).
The action is in response to the rapidly escalating Bundibugyo Ebola outbreak in the Democratic Republic of Congo (DRC), which has pressured developers to accelerate both clinical evaluation and manufacturing readiness.
As of July 29, the outbreak had resulted in 3360 confirmed cases and 1487 deaths, according to figures reported by Reuters.
Preparing for clinical-scale manufacture
Unlike the more common Zaire species of Ebola, for which Merck's Ervebo vaccine is licensed, there are currently no approved vaccines or specific treatments for Bundibugyo virus disease.
WHO experts identified the IAVI rVSV candidate as the most promising vaccine approach in May, while recommending that candidate vaccines be evaluated through clinical trials.
Under the new programme, Hilleman Laboratories will use starting material supplied by IAVI to produce finished vaccine doses for early-stage clinical studies.
Merck has said that it will provide technical and scientific expertise based on its experience with the rVSV platform, with tens of thousands of doses potentially available for clinical testing by the end of 2026.
The manufacturing strategy also highlights the importance of technology transfer in outbreak preparedness.
While Hilleman Laboratories is expected to produce sufficient quantities for early trials, the partners have indicated that technology could subsequently be transferred to a larger-scale manufacturer if demand increases.
The collaboration also builds on previous efforts to improve the manufacturability and accessibility of existing Ebola vaccines.
Merck and CEPI previously established a $30m programme to optimise Ervebo manufacturing, with the aim of increasing yields, improving affordability and extending shelf life for use in lower-income countries.
Global efforts gather pace
The Hilleman programme is one part of a broader race to establish a Bundibugyo vaccine.
CEPI is also supporting an Oxford University/Serum Institute of India candidate based on the ChAdOx1 platform used for the Oxford/AstraZeneca COVID-19 vaccine, as well as programmes involving Moderna and Public Health Vaccines.
Meanwhile, WHO has published a target product profile for Bundibugyo vaccines, setting out minimum and preferred characteristics intended to guide development, regulatory pathways and future outbreak deployment.
