If the Phase I trial is successful, Moderna plans to quickly initiate Phase II and Phase III trials of its Ebola vaccine.
Moderna has initiated a Phase I trial of its mRNA Ebola vaccine for the Bundibugyo variant, just as Africa is readying itself for research.
The first-in-human Phase I trial (NCT07737717), which will test Moderna’s vaccine candidate, mRNA-1469, has been approved by Health Canada. The study will take place at three sites in Canada and evaluate the safety, tolerability and immunogenicity of the mRNA vaccine in healthy adult participants. The study is expected to enrol approximately 80 participants.
Moderna’s mRNA-1469 is designed to prevent Bundibugyo ebolavirus disease. The candidate is being developed using the company’s mRNA platform that was used to build its successful vaccine during the Covid-19 pandemic.
Stéphane Bancel, CEO of Moderna, said: “Vaccinating the first participants with mRNA-1469 marks an important milestone in advancing a vaccine candidate against Bundibugyo ebolavirus, for which no approved vaccine currently exists.”
mRNA-1469 is being advanced under Moderna’s expanded strategic collaboration with Coalition for Epidemic Preparedness Innovations (CEPI), which has committed up to $50m to support preclinical testing and the Phase I clinical trial.
Moderna said it hopes to initiate larger Phase II and Phase III studies quickly, should the Phase I data support further development.
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. Although vaccines are available against Zaire ebolavirus, 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 3,000 confirmed cases and more than 1,400 deaths, making it one of the largest filovirus outbreaks in history.
Dr Richard Hatchett, CEPI’s CEO, said: “This fast-growing epidemic is already the second-largest Ebola outbreak in history, and cases are rising more quickly than they did in the 2014 – 2016 West Africa epidemic, which remains the largest on record. 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.”
If licensed, Moderna said it is committed to enabling rapid supply and access to its Bundibugyo vaccine for affected countries and the populations that need it. As part of its agreement with CEPI, Moderna will make available at least 500,000 doses for timely supply to low- and middle-income countries at access pricing.
Africa readies itself for Bundibugyo research
Moderna’s Phase I initiation was announced at the same time that the Africa CDC and the CEPI confirmed the continent’s capability to conduct Phase I trials to accelerate development of safe, effective Bundibugyo ebolavirus vaccines.
The institutions published a database of comprehensive information on 45 African clinical trial units across 17 African countries.
Dr Jean Kaseya, Director-General of Africa CDC, said: “Africa has the scientific expertise, infrastructure and leadership to drive vaccine research on the continent. This database gives developers a clear pathway to experienced African clinical trial sites and enables faster action when every day matters. Africa CDC 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.”
Clinical trials capacity in Africa has been built over time through partnerships between African research institutions, governments and partners in the clinical research ecosystem. Still, less than 5% of trials are conducted on the continent, despite it being home to nearly 20% of the world’s population.
Image Credit: Kitsawet Saethao / Shutterstock.com
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