The Ebola outbreak in the Democratic Republic of the Congo (DRC) is the fastest-growing in history, but the testing of new and experimental vaccines and treatments has also been speedy.
“If you compare this outbreak to previous Ebola outbreaks, we have been able to start trials more quickly," Vasee Moorthy, MD, PhD, acting head of the World Health Organization’s (WHO’s) Research and Development Blueprint program, told reporters in Geneva yesterday. "It's true that the preclinical data that we're seeing is promising.”
The current outbreak, which has sickened 3,895 people, including 1,753 fatally, is caused by the Bundibugyo ebolavirus, a rare strain of the deadly virus that has caused only three previous outbreaks. No vaccines or treatments targeting Bundibugyo exist, but drugmakers have ramped up preclinical research in recent weeks.
Moderna trial starts in Canada
Currently, more than 50 confirmed Ebola patients have been enrolled and randomly assigned to experimental treatment options at three treatment centers in DRC, according to the WHO.
DRC's National Institute for Biomedical Research has also enrolled more than 25 high-risk contacts in Ituri province to test if a 10-day course of the oral antiviral obeldesivir prevents infection after exposure.
And yesterday, Moderna announced the start of a phase 1 clinical trial in Canada, with the first participants receiving the initial doses of Moderna’s mRNA-1469 vaccine. Eighty healthy adults will be enrolled in this trial, which will assess the safety and tolerability of the vaccine.
If licensed, Moderna will make available a minimum of 500,000 doses for timely supply to low- and middle-income countries under access pricing.
Getting Moderna's vaccine candidate into a Phase 1 trial this rapidly is a major step forward in the fight against this deadly outbreak.
“Getting Moderna's vaccine candidate into a Phase 1 trial this rapidly is a major step forward in the fight against this deadly outbreak," said Richard Hatchett, MD, CEO of the Coalition for Epidemic Preparedness Innovations (CEPI), which is funding the trial. CEPI is also funding three other vaccine candidates in a portfolio approach, testing experimental vaccines in parallel.
“Every day matters and every vaccine candidate in clinical trials gives us another shot at getting a safe, effective vaccine to the people who need it as swiftly as possible,” said Hatchett.
Also today, CEPI published a new database showing 45 African clinical trial units' readiness to conduct phase 1 trials of Bundibugyo vaccines.
“This database gives developers a clear pathway to experienced African clinical trial sites and enables faster action when every day matters. Africa CDC [Centres for Disease Control and Prevention] is committed to building a research ecosystem that protects our people, strengthens health security and places African institutions at the centre of solutions to Africa’s health emergencies,” said Jean Kaseya, MD, director-general of Africa CDC, in a statement.
