Moderna begins Phase 1 trial of Bundibugyo Ebola vaccine

According to the company, the Phase 1 trial is being conducted at three sites in Canada and will assess the safety, tolerability and immune response to mRNA-1469 among about 80 healthy adult volunteers.

The vaccine candidate is based on Moderna’s mRNA technology platform and builds on the company’s previous research into filoviruses, the family of viruses that includes Ebola.

Moderna Chief Executive Officer Stéphane Bancel said vaccinating the first participants marks an important milestone in developing a vaccine against Bundibugyo ebolavirus. He thanked the Coalition for Epidemic Preparedness Innovations (CEPI), Health Canada, investigators and study volunteers for supporting the program.

The trial is part of an expanded collaboration with CEPI, which has committed up to $50 million to support preclinical testing and the Phase 1 study, as well as the production of additional clinical trial doses. The partners aim to accelerate larger Phase 2 and Phase 3 trials if Phase 1 results support further development.

CEPI Chief Executive Officer Dr. Richard Hatchett said the rapid start of the clinical trial represents an important step in responding to the ongoing Ebola outbreak, which he described as the second-largest in history and growing faster than the 2014-2016 West Africa epidemic.

Bundibugyo ebolavirus is one of the viruses that causes Ebola disease and is responsible for the current outbreak in the Democratic Republic of the Congo. While vaccines are available against Zaire ebolavirus, none are approved for BDBV.

According to Moderna, the outbreak has resulted in more than 3,000 confirmed cases and over 1,400 deaths. The World Health Organization declared it a Public Health Emergency of International Concern, while the Africa Centres for Disease Control and Prevention declared it a Public Health Emergency of Continental Security.

If the vaccine is eventually licensed, Moderna said it plans to provide rapid access to affected countries and has committed to making at least 500,000 doses available to low- and middle-income countries under access pricing through its agreement with CEPI.

Earlier, Qazinform News Agency reported that the World Health Organization added the first molecular diagnostic test for the Bundibugyo virus (BDBV) to its Emergency Use Listing (EUL) and launched a clinical trial to evaluate the first potential treatments for the disease.