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The first US clinical trial of a Covid-19 vaccine candidate, which is Moderna’s mRNA-1273, has started at Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle.
Funded by the National Institutes of Health (NIH)’s National Institute of Allergy and Infectious Diseases (NIAID), the trial has dosed its first participant.
mRNA-1273 is an mRNA vaccine designed to target SARS-CoV-2 encoding a prefusion stabilised form of the Spike (S) protein. Moderna selected the candidate in alliance with the Vaccine Research Center (VRC) at the NIAID.
The Coalition for Epidemic Preparedness Innovations (CEPI) funding supported the production of the first clinical batch.
During the Phase I trial, the safety and immunogenicity of 25μg, 100μg, 250μg dose levels of mRNA-1273 given on a two-dose vaccination schedule 28 days apart will be assessed in a total of 45 healthy adults aged 18 to 55.
The study involves a follow-up of 12 months after the second vaccination.
The primary objective is the safety and reactogenicity of a two-dose vaccination schedule, while the secondary objective is immunogenicity to the SARS-CoV-2 S protein.
Moderna chief medical officer Tal Zaks said: “This study is the first step in the clinical development of an mRNA vaccine against SARS-CoV-2, and we expect it to provide important information about safety and immunogenicity. We are actively preparing for a potential Phase II study under our own IND.
“We are grateful to NIH for their ongoing collaboration and to CEPI for funding the initial manufacturing of mRNA-1273 and are proud to be included with the many companies, worldwide health agencies and NGOs working on a possible response to the novel coronavirus outbreak.”
The potential Phase II and any subsequent trials will further evaluate the safety and immunogenicity of the vaccine candidate in a larger population. Moderna has already started manufacturing the mRNA-1273 material for the Phase II study.