Lead image for WHO clears path for Ebola vaccine trial as Bundibugyo outbreak surges.
The World Health Organization has recommended that Ervebo, the only licensed Ebola vaccine, be tested against the Bundibugyo virus as the Democratic Republic of Congo battles an outbreak that has exposed a critical gap in protection against the disease.
The recommendation could pave the way for a Phase 3 clinical trial during the ongoing outbreak, after new laboratory and animal evidence suggested that the vaccine may offer cross-protection against Bundibugyo virus, including protection against death.
The decision was reached by WHO's Technical Advisory Group on Candidate Vaccine Prioritization (TAG-CVP), which met on July 31 to review emerging evidence and assess vaccine options for the outbreak in the Democratic Republic of Congo and Uganda.
The advisory group recommended that Ervebo be prioritised for inclusion in a Phase 3 clinical trial, without first conducting a separate Phase 2 study.
WHO said the urgency of the outbreak and the need to generate evidence that could guide future policy decisions made a direct move to Phase 3 appropriate.
The proposed trial would use a ring vaccination strategy, in which people who have been exposed to confirmed Ebola cases, together with their contacts, are vaccinated to create a protective ring around infected individuals.
The approach could allow researchers to determine whether Ervebo protects people exposed to Bundibugyo virus while also contributing to outbreak control.