3D print of a spike protein of SARS-CoV-2, the virus that causes COVID-19, in front of a 3D print of a SARS-CoV-2 virus particle. Credit: NIH.

Moderna has filed an investigational new drug (IND) application with the US Food and Drug Administration (FDA) to conduct a Phase II clinical trial of its mRNA vaccine candidate, mRNA-1273, against Covid-19.

The study is expected to be supported by safety data from the ongoing Phase I study, which is led by the US National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID).

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Moderna said that the FDA provided initial feedback on the design of the Phase II study, which is set to launch in the second quarter of this year.

The Phase II trial will assess the safety, reactogenicity and immunogenicity of two mRNA-1273 vaccinations administered 28 days apart. Participants will be given a placebo, a 50μg, or a 250μg dose at both vaccinations.

Around 600 healthy volunteers aged 18 years and above will be enrolled for the trial, which will follow the participants for 12 months following the second vaccination.

Moderna chief medical officer Tal Zaks said: “Submitting this IND is an important next step in the clinical development of our mRNA vaccine against SARS-CoV-2, and we are moving rapidly to potentially address this global health emergency.

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“We look forward to launching this Phase II study as soon as possible, which will provide important information about the safety, reactogenicity and immunogenicity of mRNA-1273.”

The Phase III study of the vaccine candidate, expected to begin later this year, is subject to data from Phase I and II trials.

Earlier this month, Moderna started enrolment of participants for the highest dose arm of a Phase I trial. The trial will recruit a total of 45 healthy adults aged 18 to 55.

The company received funding from the US Biomedical Advanced Research and Development Authority (BARDA) and the funds were used to plan for the Phase II and III studies.

In addition, the funding will support late-stage clinical development programmes and the scale-up of mRNA-1273 manufacturing.