SARS-CoV-2 Vaccine Candidate Doses Phase 2 Study Participants
A Massachusetts based biotechnology company pioneering messenger RNA (mRNA) vaccines announced that the first participants have been dosed in a Phase 2 study for mRNA-1273, a preventive vaccine against the SARS-CoV-2 coronavirus.
mRNA-1273 is an mRNA vaccine against SARS-CoV-2 encoding for a prefusion stabilized form of the Spike (S) protein.
Moderna, Inc., said on May 29, 2020, this Phase 2 study will evaluate the safety, reactogenicity, and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart.
The Company intends to enroll 600 healthy participants across two cohorts of adults ages 18-55 years and older adults ages 55 years and above. Each participant will be assigned to receive a placebo, a 50 μg or a 100 μg dose at both vaccinations.
Study participants will be followed through 12 months after the second vaccination.
On May 18, Moderna announced initial data from the Phase 1 study of mRNA-1273 led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
Given the 25 μg and 100 μg dose levels in the Phase 1 study showed neutralizing antibody titers at or above convalescent sera and were generally well tolerated, the Company has decided not to pursue the 250 μg dose level in the Phase 2 study.
The NIH will be submitting the Phase 1 data to a peer-reviewed clinical publication.
Moderna anticipates collaborating with NIAID to implement the Phase 3 study. The dose for the Phase 3 study is expected to be between 25 µg and 100 µg and expects Phase 3 trial initiation in July, subject to finalization of the clinical trial protocol.
Funding from the Biomedical Advanced Research and Development Authority, a division of the Office of the Assistant Secretary for Preparedness and Response, within the U.S. Department of Health and Human Services, supported the planning for these studies and will also support the late-stage clinical development programs, as well as the scale-up of mRNA-1273 manufacturing both at the Company’s facilities and that of its strategic collaborator, Lonza Ltd.
Moderna scientists designed the company’s prophylactic vaccine modality to prevent infectious diseases.
The potential advantages of an mRNA approach to prophylactic vaccines include the ability to combine multiple mRNAs into a single vaccine, rapid discovery to respond to emerging pandemic threats, and manufacturing agility derived from the platform nature of mRNA vaccine design and production.
Moderna has built a fully integrated manufacturing plant that enables the promise of the technology platform.
Headquartered in Cambridge, Mass., Moderna has been named a top biopharmaceutical employer by Science for the past five years.
Precision Vaccinations publishes coronavirus vaccine development news.