Moderna has announced the dosing of the first participant in a phase1 study of mRNA-1273, the company’s mRNA vaccine candidate against the novel coronavirus (SARS-CoV-2).
The early-stage study of mRNA-1273 is being carried out by the US National Institutes of Health (NIH) under its own investigational new drug (IND) application.
According to the company, the mRNA vaccine is intended to act against SARS-CoV-2 encoding for a prefusion stabilised form of the Spike (S) protein, which was selected by it in collaboration with investigators from the Vaccine Research Center (VRC).
The VRC is part of the NIH’s National Institute of Allergy and Infectious Diseases (NIAID), a part of NIH.
Moderna said that the Coalition for Epidemic Preparedness Innovations (CEPI) had funded the manufacturing of the first clinical batch of the vaccine candidate.
The phase 1 study will examine the safety and immunogenicity of three dose levels of mRNA-1273 (25, 100, 250 μg) to be given on a two-dose vaccination schedule, with a gap of 28 days.
The company intends to have 45 healthy adults in the early-stage trial, who will be followed through 12 months after the date of the second vaccination.
Moderna’s primary objective is to assess the safety and reactogenicity of a two-dose vaccination schedule of its mRNA candidate. The trial’s secondary objective is to study the 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 2 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 clinical stage biotechnology company said that it is also actively working towards a potential phase 2 trial under its own IND to build on data from the currently held phase 1 trial.