Planning Underway for Phase 2 Trial of COVID-19 mRNA Vaccine

The biotechnology company Moderna, which specializes in messenger RNA (mRNA) therapeutics and vaccines, announced in a statement that they are submitting an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for a coronavirus disease 2019 (COVID-19) vaccine candidate.

The firm hopes to initiate phase 2 and late-stage studies of its vaccine candidate, mRNA-1273, against COVID-19.

“mRNA-1273 is an mRNA vaccine against SARS-CoV-2 encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators from Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID),” the statement read.

The initiation of these studies would be based on review of safety data from a Phase 1 study supported by NIAID, a part of the National Institutes of Health.

The phase 1 NIAID study began on March 16, 2020, and enrolled 45 adult participants ages 18 to 55 years in 3 original dose cohorts (25 µg, 100 µg and 250 µg). The study is currently enrolling an additional 6 cohorts: 3 cohorts of older adults (ages 56-70) and 3 cohorts ages 71 and above.

The FDA has corresponded with Moderna on the design of the potential phase 2 study, expected to begin in mid-2020. The study will aim to explore the safety, immunogenicity, and reactogenicity of 2 doses of mRNA-1273 administered 28 days apart.

A total of 600 participants will be assigned to receive placebo, 50 μg, or 250 μg of the vaccine in both vaccinations. Participants will then be followed for 12 months after vaccination.

Participants will range from 18-55 years in a 300 person cohort, and 55 years+ in another 300 person cohort.

“We look forward to launching this Phase 2 study as soon as possible, which will provide important information about the safety, reactogenicity and immunogenicity of mRNA-1273,” said Tal Zaks, MD, PhD, Chief Medical Officer at Moderna, in the company’s statement.

If the study results point toward further development, a Phase 3 study may be pursued in the fall of 2020. The planning for these studies, late-stage clinical development programs, and the potential scale-up of manufacturing for the vaccine have been funded by the US Biomedical Advanced Research and Development Authority (BARDA).

“Safe, effective vaccines are critical to ending this pandemic and preventing future outbreaks of SARS-COV-2,” said BARDA Acting Director Gary Disbrow, PhD in the company statement. “The next steps announced today for this particular vaccine highlight the value of collaboration among government agencies including BARDA and NIAID, and the private sector, to move vaccines and other medical countermeasures forward as rapidly as possible.”