Cambridge-Based Moderna, Inc. Launches Phase 1 Study of Potential Coronavirus Vaccine
GoLocalProv News Team
Cambridge-Based Moderna, Inc. Launches Phase 1 Study of Potential Coronavirus Vaccine
This Phase 1 study is being conducted by the National Institutes of Health (NIH) under its own Investigational New Drug (IND) application.
According to the company, the Phase 1 study is evaluating the safety and immunogenicity of three dose levels of mRNA-1273 (25, 100, 250 μg) administered on a two-dose vaccination schedule, given 28 days apart. A total of 45 healthy adults will be enrolled in the study. Participants will be followed through 12 months after the second vaccination. The primary objective is to evaluate the safety and reactogenicity of a two-dose vaccination schedule of mRNA-1273. The secondary objective is to evaluate the immunogenicity to the SARS-CoV-2 S protein.
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Timeline of the company's response through March 16, 2020
On January 11, 2020, the Chinese authorities shared the genetic sequence of the novel coronavirus.
On January 13, 2020, the U.S. National Institutes of Health (NIH) and Moderna’s infectious disease research team finalized the sequence for mRNA-1273, the Company’s vaccine against the novel coronavirus. At that time, the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, disclosed their intent to run a Phase 1 study using the mRNA-1273 vaccine in response to the coronavirus threat and Moderna mobilized toward clinical manufacture. Manufacture of this batch was funded by the Coalition for Epidemic Preparedness Innovations (CEPI).
On February 7, 2020, the first clinical batch, including fill and finishing of vials, was completed, a total of 25 days from sequence selection to vaccine manufacture. The batch then proceeded to analytical testing for release.
On February 24, 2020, the clinical batch was shipped from Moderna to the NIH for use in their Phase 1 clinical study.
On March 4, 2020, the U.S. Food and Drug Administration (FDA) completed its review of the Investigational New Drug (IND) application filed by the NIH for mRNA-1273 and allowed to the study to proceed to begin clinical trials.
On March 16, 2020, the NIH announced that the first participant in its Phase 1 study for mRNA-1273 was dosed, a total of 63 days from sequence selection to first human dosing.
"This Phase 1 study will provide important data on the safety and immunogenicity of mRNA-1273. Immunogenicity means the ability of the vaccine to induce an immune response in participants. The open-label trial is expected to enroll 45 healthy adult volunteers ages 18 to 55 years over approximately six weeks," said the company.