moderna vaccine trial aimed at international ebola outbreak begins in nova scotia
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the first participant getting dosed in moderna's clinical trial for a new vaccine against bundibugyo ebolavirus in truro.
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moderna
the first participants in moderna’s new trial for an experimental vaccine got their dose in truro this week, and a similar trial in halifax will follow suit in the coming days.
this launches the company’s efforts against the current ebola outbreak.
they are testing mrna-1469, an experimental vaccine currently under study to prevent bundibugyo virus disease (bvd), caused by bundibugyo ebolavirus (bdbv).
according to moderna, the trial vaccine builds on its previous research into filoviruses, like ebola, as well as making use of the mrna platform, the same platform used for the development of the covid-19 vaccine.
“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,” stéphane bancel, chief executive officer of moderna, said in a news release tuesday.
the trial is being conducted in partnership with the coalition for epidemic preparedness innovations (cepi), a global health partnership aimed at supporting accelerated development of vaccines against emerging epidemics, which has committed to supporting the preclinical testing and the first phase of the trial up to $50 million usd.
why here?
the first phase of the study, authorized by health canada on july 30, will have healthy adult participants enrolled at three different sites, all within canada: in toronto, truro and halifax.
hamilton bennett, moderna’s executive director of global health security and research and development partnerships, said the company chose canada for the initial study because of established relationships with canadian researchers and the country’s track record working with them
according to health canada’s clinical trial registry, the trial sites in nova scotia are the canadian centre for vaccinology in halifax and the colchester research group in truro.
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bennett said that “the two nova scotia sites were selected based on relevant investigator expertise, clinical trial experience, operational readiness, participant recruitment capacity, and ability to begin the study within the required timelines.”
canada is the second country moving forward with the first phase of a clinical trial looking at a potential bundibugyo virus vaccine, behind only the united kingdom.
getting started
according to bennet, the first phase is to determine if the vaccine is safe, establish dosage and to identify side effects if they do appear. the approximately 80 healthy adult participants will be followed for 12 months, with results expected in fall 2026.
health canada emphasized that participants will not be injected with the virus itself and cannot contract ebola disease through the trial.
instead, researchers will be administering a dose of the trial vaccine to healthy adults to observe whether there is an immune response that creates bundibugyo virus antibodies.
determining the vaccines’ ability to prevent illness in exposed populations will come in later trial phases.
bundibugyo ebolavirus
bundibugyo virus is an often fatal form of the ebola disease caused by bdbv.
currently, there is an active outbreak of the illness in the democratic republic of the congo (drc) that is quickly growing, already turning into one of the largest ebola outbreaks ever and one urgently needing a solution.
“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,” cepi’s chief executive officer dr. richard hatchett said.
“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.”
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according to the world health organization, there are a total of 3,605 confirmed cases and about 1,587 deaths in the drc as of july 30.
looking forward
despite only recently starting early phases of human testing, bennet said the study will be moved along quickly in order to respond to the current global crisis.
“the study is moving quickly in response to the urgent international public health need,” she said.
moderna said that their partnership with cepi allows them to manufacture more trial doses while the early phases are underway, allowing the second and third phase studies, which are a larger undertaking, to begin right away if results support development.
also as part of the agreement with cepi, moderna will be responsible for making at least 500,000 doses available under access pricing for quick distribution to low- and middle-income countries if the vaccine is approved.
“moderna is committed to enabling rapid supply and access of its bdbv vaccine to affected countries and to the populations that need them,” the company wrote.
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