Moderna said it has shipped the first batch of its clinic-bound vaccine against novel coronavirus, mRNA-1273, to the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) for use in a planned Phase I study in the U.S.
The study, “Safety and Immunogenicity Study of 2019-nCov Vaccine (mRNA-1273) to Treat Novel Coronavirus” (NCT04283461), was disclosed by NIAID today on ClinicalTrials.gov. The open-label, dose-ranging trial is designed to assess the safety, reactogenicity and immunogenicity of Moderna’s mRNA-1273, a novel lipid nanoparticle (LNP)-encapsulated mRNA vaccine against the novel coronavirus encoding for a prefusion stabilized form of the Spike (S) protein, which was designed by Moderna in collaboration with investigators at the NIAID Vaccine Research Center (VRC).
According to NIAID, 45 participants will be enrolled into one of three cohorts and will receive an intramuscular (IM) injection of mRNA-1273 on Days 1 and 29 in the deltoid muscle. The participants will be followed through 12 months post second vaccination (Day 394). The primary objective is to evaluate the safety and reactogenicity of a 2-dose vaccination schedule of mRNA-1273, given 28 days apart, across 3 dosages in healthy adults.
Participants will receive an IM injection (0.5 mL) of mRNA-1273 on Days 1 and 29 in the deltoid muscle and will be followed through 12 months post second vaccination (Day 394). Follow-up visits will occur 1, 2 and 4 weeks post each vaccination (Days 8, 15, 29, 36, 43, and 57), as well as 3, 6, and 12 months post second vaccination (Days 119, 209 and 394), NIAID added.
“The primary objective is to evaluate the safety and reactogenicity of a 2-dose vaccination schedule of mRNA-1273, given 28 days apart, across 3 dosages in healthy adults,” NIAID stated. “The secondary objective is to evaluate the immunogenicity as measured by IgG ELISA to the 2019-nCoV S protein following a 2-dose vaccination schedule of mRNA-1273 at Day 57.”
According to Moderna, the S protein complex is necessary for membrane fusion and host cell infection and has been the target of vaccines against the coronaviruses responsible for Middle Eastern Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS).
Moderna manufactures its portfolio of mRNA development candidates, including vaccines and therapeutics, at its manufacturing plant in Norwood, MA. To date, the company said, it has produced and released more than 100 batches from its Norwood site for human clinical trials. Manufacturing of the batch was funded by the Coalition for Epidemic Preparedness Innovations (CEPI).
42-day clinical batch
“I want to thank the entire Moderna team for their extraordinary effort in responding to this global health emergency with record speed,” Juan Andres, chief technical operations and quality officer at Moderna, said yesterday in a statement. “The collaboration across Moderna, with NIAID, and with CEPI has allowed us to deliver a clinical batch in 42 days from sequence identification. This would not have been possible without our Norwood manufacturing site, which uses leading-edge technology to enable flexible operations and ensure high quality standards are met for clinical-grade material.”
Shares of Moderna rose 13% in early trading on the news, to $21.04 as of 11:26 a.m. from yesterday’s closing price of $18.59.
mRNA-1273 is one of nine development candidates in Moderna’s prophylactic vaccines modality, designed to prevent infectious diseases. More than 1,000 participants have been enrolled in clinical studies of Moderna’s infectious disease vaccines being conducted under the auspices of health authorities in the U.S., Europe, and Australia. Moderna’s prophylactic vaccines have had six positive Phase I clinical readouts across six different vaccines over the past four years.
Moderna says it has designated prophylactic vaccines a core modality and intends to accelerate development of its infectious disease vaccine candidates, based on clinical results generated from six Phase I studies. Of Moderna’s nine phophylactic vaccines candidates, five are indicated against serious respiratory infections:
- Respiratory syncytial virus (RSV) vaccine for older adults (mRNA-1777 and mRNA-1172/V172, partnered with Merck & Co.)
- RSV vaccine for young children (mRNA-1345)
- Human metapneumovirus and parainfluenza virus type 3 (hMPV/PIV3) vaccine (mRNA-1653)
- Influenza H7N9 (mRNA-1851)
The other Moderna prophylactic vaccine candidates include a Cytomegalovirus (CMV) vaccine (mRNA-1647); an Epstein-Barr virus (EBV) vaccine (mRNA-1189); and a Zika vaccine (mRNA-1893) being developed with the Biomedical Advanced Research and Development Authority (BARDA).
