1st person inoculated in trial for Ebola vaccine to protect against strain behind DRC outbreak
The trial will test multiple vaccine candidates.
The first person has been inoculated in a clinical trial for a vaccine that could help protect against the viral strain behind the Ebola outbreak in the Democratic Republic of the Congo (DRC), according to Médecins Sans Frontières (Doctors Without Borders).
Bundibugyo ebolavirus (BDBV), a rare variant of Ebola, is behind the DRC outbreak that has led to more than 10,000 cases and nearly 5,000 deaths, the World Health Organization Regional Office for Africa posted Tuesday. There are no currently no vaccines or treatments available to treat Bundibugyo virus.
The Tumaini clinical trial, as it's known, is evaluating the safety, efficacy and immunogenicity -- meaning the ability to generate an immune response -- of several vaccine candidates.
The trial is being co-sponsored and co-led by the Institut National de Recherche Biomédicale in the DRC and the University of Antwerp's Global Health Institute in Belgium. Partners include the Congo Ministry of Health, Médecins Sans Frontières (MSF), the Coalition for Epidemic Preparedness Innovations (CEPI), Africa Centres for Disease Control and Prevention, the World Health Organization, and the Institute of Tropical Medicine in Antwerp.
Participants are made up of people who at the time of enrollment were contacts within the previous 21 days of a patient who is a newly confirmed case of Bundibugyo virus disease, according to a summary of the clinical trial posted on the National Institutes of Health website.
On day 1 of the trial, participants are randomized to receive either a BDBV vaccine candidate or standard treatment, according to the clinical trial summary. On day 29, all participants receive the alternative intervention so that every participant is offered a candidate vaccine while allowing the comparison between groups to remain blinded.
An independent data monitoring committee will review data accumulated during the trial while additional vaccine candidates are added to the evaluation and others are discontinued if they are shown to be ineffective.
"The overall aim is to generate robust evidence to support the use of BDBV vaccines for outbreak response and future epidemic preparedness," the summary states.
MSF said Monday that the first vaccine candidate being studied is ERVEBO, which was developed and licensed to protect against the Zaire ebolavirus, which is the deadliest Ebola strain.
At least two Bundibugyo-specific vaccine candidates being developed by Moderna and the University of Oxford in collaboration with the Serum Institute of India, and funded by CEPI, will be tested, according to MSF, which also said the Tumaini trial will notably include children.
"Children are among those hardest hit by the Ebola outbreak in certain regions, yet they have historically been underrepresented in clinical research," said Valérie Briand, head of MSF's research division, Epicentre. "The inclusion of pregnant women and children aged 12 years and older, as well as children from one year of age for the ERVEBO vaccine, represents an important step toward generating evidence for populations that are often excluded from clinical trials."
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