DR Congo has begun the Tumaini vaccine trial in Bunia, where the first participant was vaccinated on 23 October. Researchers will test whether vaccine candidates can protect people against Bundibugyo virus during the continuing Ebola outbreak.
Ervebo is the first candidate entering the Phase 2/3 study, according to a joint announcement published by the Institute of Tropical Medicine in Antwerp. There is currently no approved vaccine against Bundibugyo, and the start of vaccination does not establish that the product protects people against this virus.
The trial will assess safety, immune responses and effectiveness. Its adaptive design allows several candidates to be evaluated within one framework. Ring vaccination will focus on contacts at high risk of infection. Preparations are underway for Bundibugyo-specific candidates developed by Moderna and the University of Oxford with the Serum Institute of India to enter the study.
Ervebo is already authorised against disease caused by Zaire Ebola virus, a different virus from Bundibugyo. The European Medicines Agency says the vaccine contains a weakened and modified vesicular stomatitis virus carrying a protein from Zaire Ebola virus. It cannot cause Ebola virus disease.
The agency's account of the evidence supporting that authorisation includes a study conducted in Guinea. Researchers compared immediate vaccination with vaccination delayed by 21 days among people connected to confirmed cases. That evidence concerns the existing indication and does not establish effectiveness against Bundibugyo.
Congo's Institut National de Recherche Biomédicale and the University of Antwerp co-lead and co-sponsor Tumaini. The Congolese health ministry provides national leadership and oversight, with support from international research and outbreak-response partners.
The Institute of Tropical Medicine is responsible for laboratory activities and immune-response assessments. Results are not yet available.
The World Health Organisation identifies rapid case detection, contact tracing, infection prevention and community participation among the measures needed to control Ebola outbreaks. Early supportive care, including rehydration and treatment of symptoms, can improve survival.
Ebola spreads through direct contact with infected blood or other bodily fluids, and with contaminated materials. WHO says the incubation period ranges from two to 21 days and people do not transmit the disease before symptoms begin. Vaccine research therefore operates alongside measures to identify illness, protect health workers and interrupt transmission.
Archive location photograph: Bunia city centre, uploaded 29 May 2010; exact capture date unknown. Not the trial or its participants. Dans via Wikimedia Commons, CC BY-SA 3.0. Cropped and resized; photographic adaptations retain the same licence.
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