The Coalition for Epidemic Preparedness Innovations (CEPI) has announced funding for three experimental Bundibugyo ebolavirus vaccine candidates currently in preclinical development. Bundibugyo is the ebolavirus species responsible for the current outbreak in the Democratic Republic of Congo ad Uganda, but no licensed vaccine is currently available for this species, and none is in clinical development.
The three vaccine candidates are under development by Moderna Inc, the University of Oxford (whose vaccine will be manufactured by the Serum Institute of India Pvt Ltd), and IAVI (the International AIDS Vaccine Initiative), each longstanding partners of CEPI. They were chosen on the basis of CEPI’s global review of Bundibugyo virus vaccines in development and extensive consultation with WHO, Africa CDC (the Africa Centres for Disease Control and Prevention based in Addis Ababa, Ethiopia), ANRS MIE (the French National Research Agency for HIV, viral hepatitis and emerging infectious diseases), Gavi, the vaccine alliance, and affected countries.
Each candidate vaccine is based on a different validated vaccine technology, which CEPI hopes will maximise the chances of success. Moderna’s candidate is based on the same mRNA technology used to develop the company’s Covid-19 vaccines and which it is concurrently exploiting through its R&D on related Ebola viruses. CEPI has committed up to $50 million for preclinical testing and Phase 1 clinical trials, and will support simultaneous manufacture of doses to enable large-scale Phase 2/3 trials to begin immediately.
In addition, CEPI has committed initial funding of $8.6 million to fund preclinical testing and to prepare for Phase 1 testing of the University of Oxford’s Bundibugyo virus candidate, which is based on the same ChAdOx1 platform used in the Oxford Covid-19 vaccine (which was commercialised by AstraZeneca Plc). The funding will also be used to create a Master Virus Seed stock by Serum Institute under an existing agreement with CEPI.
Lastly, CEPI has committed up to $3.2 million to support IAVI in the preparation and testing of a Master Virus Seed stock using a process developed at the University of Texas Medical Branch. This candidate uses the rVSV vaccine platform, which is based on an approved and WHO-prequalified vaccine against Zaire ebolavirus. The platform is seen as crucial for vaccines deployed in outbreak settings due to its rapid onset of protective immunity after a single dose.
CEPI says the funding will rapidly advance the vaccine candidate so they can begin clinical trials as soon as possible. Each of the underlying vaccine technology platforms has extensive safety data and has been used to develop vaccine candidates that have shown preclinical or clinical efficacy against viruses related to Bundibugyo ebolavirus. If Phase 1 trials are successful, CEPI anticipates working with its partners to support late-stage trials and to develop data to support emergency use authorisation or licensure. It says the current Bundibugyo epidemic, and the recent Hantavirus cruise ship incident, underline the need to invest in preparedness for increasingly complex infectious disease threats.
In a related development, Gavi said it is to make up to $50 million available through its First Response Fund to support the response to the current Bundibugyo outbreak. Up to $40 million of this will be used in partnership with CEPI, WHO, Africa CDC and UNICEF to enable manufacturers of the leading vaccine candidates to commit to high-capacity manufacturing. Gavi also said it will provide incentives for manufacturers to adopt the fastest pathways towards WHO Emergency Use Listing and/or WHO Prequalification. A further $10 million will be directed to supporting immediate outbreak response needs.
- By Peter Charlish