A biotechnology company pioneering messenger RNA (mRNA) vaccines announced that the initial participant has been dosed in the Phase 1 clinical study of the mRNA-1273 vaccine candidate, targeted against the novel coronavirus known as SARS-CoV-2.

Moderna, Inc. announced on March 16, 2020, that this Phase 1 study is being conducted by the National Institutes of Health (NIH) under its own Investigational New Drug (IND) application.

The mRNA-1273 vaccine encodes for a prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators from the Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), a part of NIH.

The Phase 1 study is evaluating the safety and immunogenicity of 3 dose levels of mRNA-1273 (25, 100, 250 μg) administered on a two-dose vaccination schedule, given 28 days apart.

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 of the SARS-CoV-2 S protein.

A total of 45 healthy adults will be enrolled in the study. Participants will be followed through 12 months after the second vaccination.

“We are actively preparing for a potential Phase 2 study under our own IND,” said Tal Zaks, M.D., Ph.D., Chief Medical Officer at Moderna, in a press release.

“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.”

On January 11, 2020, the Chinese authorities shared the genetic sequence of the novel coronavirus. On January 13, 2020, the VRC and Moderna’s infectious disease research team finalized the sequence for the SARS-CoV-2 vaccine and Moderna mobilized toward clinical manufacture.

The first clinical batch was completed on February 7, 2020, and underwent analytical testing; it was shipped on February 24, 2020, from Moderna and delivered to NIH from the Company’s manufacturing facility in 42 days from sequence selection.

The Company is actively preparing for a potential Phase 2 study under its own IND to build on data from the ongoing Phase 1 study being conducted by the NIH.

In order to continue to progress this potential vaccine during the ongoing global public health emergency, Moderna intends to work with the FDA and other government and non-government organizations to be ready for a Phase 2 and any subsequent trials, which are anticipated to include a larger number of subjects and which will seek to generate additional safety and immunogenicity data.

Manufacture of the mRNA-1273 material for the potential Phase 2 trial, which could begin in a few months, is underway.

Moderna continues to prepare for the rapid acceleration of its manufacturing capabilities that could allow for the future manufacture of millions of doses should mRNA-1273 prove to be safe and effective.

Coronaviruses are a family of viruses that can lead to respiratory illness, including Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV).

On January 7, 2020, a novel coronavirus (SARS-CoV-2) was identified as the cause of pneumonia cases in Wuhan, Hubei Province of China, and additional cases have been found in a growing number of countries.

The potential advantages of an mRNA approach to prophylactic vaccines include the ability to mimic natural infection to stimulate a more potent immune response, combining 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 in Norwood, MA which enables the promise of the technology platform.

SARS-CoV-2 vaccine development news published by Precision Vaccinations.