The company has reported positive interim clinical data of mRNA-1273 from the phase 1 study by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
The mRNA-1273 is an mRNA vaccine against SARS-CoV-2 encoding for a prefusion stabilised form of the Spike (S) protein.
Recently, Moderna has secured fast track designation from the US Food and Drug Administration (FDA) for its mRNA-1273 vaccine.
Moderna has revealed the immunogenicity data for the 25 µg and 100 µg dose level ages 18-55) after two doses (day 43) and at the 250 µg level (ages 18-55) after one dose (day 29).
According to the company, the dose-dependent increases in immunogenicity have been observed across the three dose levels, and between prime and boost within the 25 µg and 100 µg dose levels.
The company has revealed the neutralising antibody data for the first four participants in each of the 25 µg and 100 µg dose level cohorts.
Moderna’s mRNA-1273 vaccination elicited neutralising antibodies in all eight of these participants, which is in line with the binding antibody data. It has been measured by plaque reduction neutralisation (PRNT) assays against live SARS-CoV-2.
The levels of neutralising antibodies day 43 were at or above levels generally observed in convalescent sera, said the company.
Moderna has also announced the preclinical results from a viral challenge study, which was carried out in collaboration with NIAID and its academic partners.
The vaccination with mRNA-1273 restricted viral replication in the lungs of animals challenged with SARS-CoV-2 in the study.
Neutralising titers in phase 1 clinical trial participants at the 25µg and 100µg levels were in line with neutralising titers, which were protective in the mouse challenge model.
Moderna-led phase 2 study will be amended to study two dose levels, including 50µg and 100µg, based on the interim phase 1 data.
The company will amend the NIAID-led phase 1 study to include a 50 µg dose level cohort across each of the three age groups.
Moderna CEO Stéphane Bancel said: “With today’s positive interim Phase 1 data and the positive data in the mouse challenge model, the Moderna team continues to focus on moving as fast as safely possible to start our pivotal Phase 3 study in July and if successful, file a BLA.”