Moderna announced Monday that the first subject has been dosed in a Phase I study of its experimental mRNA vaccine mRNA-1273 against SARS-CoV-2. The Phase I trial, which is being conducted by the US National Institutes of Health (NIH) at Kaiser Permanente Washington Health Research Institute in Seattle, aims to recruit a total of 45 healthy adults, ages 18 to 55 years, over a period of approximately six weeks and will evaluate three dose levels of mRNA-1273.
The drugmaker noted that mRNA-1273 encodes for a prefusion stabilised form of the Spike (S) protein that protrudes from the viral surface. Moderna said participants will receive two doses of the vaccine, given 28 days apart, and will be followed through 12 months after the second immunisation. The primary objective is to evaluate safety and reactogenicity of a two-dose vaccination schedule for mRNA-1273, while the secondary goal will assess immunogenicity to the SARS-CoV-2 S protein.
"This study is the first step in the clinical development of an mRNA vaccine against SARS-CoV-2," remarked Moderna's chief medical officer Tal Zaks, adding "we are actively preparing for a potential Phase II study." The company noted that manufacturing is currently underway for mRNA-1273 material that would be used in a potential mid-stage trial, which could begin "in a few months." Moderna added that it "continues to prepare for rapid acceleration of its manufacturing capabilities that could allow for the future manufacture of millions of doses, should mRNA-1273 prove to be safe and effective."
The Coalition for Epidemic Preparedness Innovations, which supported manufacturing of the vaccine candidate for use in the Phase I trial, recently warned that a funding gap of about $2 billion could potentially hamper development of a vaccine against COVID-19.
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