The World Health Organization (WHO) will add two more Ebola vaccines to the ongoing Tumaini clinical trial.
The Phase II/III study (NCT07842107), which is being conducted in the Democratic Republic of the Congo (DRC), will now also evaluate ChAdOx1, developed by the University of Oxford with the Serum Institute of India, and Moderna’s mRNA-1469, which are specifically designed for the Bundibugyo virus, the virus responsible for the current outbreak.
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The WHO’s independent Technical Advisory Group on Candidate Vaccines Prioritization recommended both vaccines for further clinical evaluation this week, based on available preclinical and early clinical evidence.
The companies were informed on Monday. The vaccine candidates will enter the trial following national approvals.
Dr Tedros Adhanom Ghebreyesus, WHO director-general, said: “The fact that these vaccines are ready to enter clinical trials is a testament to the power of science and partnership.”
“Vaccines alone will not end this outbreak, but they could become a powerful new tool for bringing it under control,” Adhanom Ghebreyesus added.
Tumaini is designed to test multiple vaccine candidates within a single trial using a ring-vaccination approach that enrols contacts of people with confirmed Bundibugyo virus disease.
It builds on an approach pioneered by WHO and its partners during the West Africa Ebola outbreak a decade ago, when a landmark trial in Guinea established the efficacy of MSD’s Ervebo against Ebola virus, also known as Zaire ebolavirus.
Ervebo was the first vaccine evaluated in a Tumaini trial to assess its efficacy against Bundibugyo virus. Results have not been released.
The adaptive platform trial is led by the Institut National de Recherche Biomédicale, along with the University of Antwerp, and other research organisations.
Bundibugyo is one of the viruses that can cause Ebola disease and has been responsible for the active outbreak in the Democratic Republic of the Congo, and no vaccine is currently approved to protect against disease caused by Bundibugyo.
The current outbreak was declared a Public Health Emergency of International Concern (PHEIC) and a Public Health Emergency of Continental Security (PHECS) by the World Health Organization (WHO) and Africa Centres for Disease Control and Prevention (Africa CDC), respectively. It has already caused more than 4,600 confirmed cases and more than 2,100 deaths, making it one of the largest filovirus outbreaks in history.
Vaccines only part of the answer
While this marks an advance for vaccines, research is also being conducted into potential treatments.
The WHO-sponsored PARTNERS trial, launched in July, is evaluating whether Mapp Biopharmaceutical’s monoclonal antibody (mAb) MBP134, Gilead’s antiviral Veklury (remdesivir), or a combination of both can improve survival in patients with confirmed Bundibugyo virus disease.
Regeneron’s maftivimab will soon be added to the trial to assess its use as a potential treatment, and a complementary post-exposure prophylaxis study with Gilead’s obeldevisir is underway.
Initial findings from the treatment trials are expected in the coming months, with results from the vaccine trial expected in early 2027.
