Coronavirus Vaccine: Moderna Releases Phase 1 Interim Data

Modern biotechnology company Messenger RNA (mRNA) therapeutics and vaccines pioneer Moderna, Inc., is on Monday in a clinical trial of a candidate vaccine for the novel coronavirus (SARS-CoV-2), mRNA-1273. The interim data of was announced. By the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health (NIH).

Currently, immunogenicity data are available at dose levels of 25 µg and 100 µg (18-55 years) after two doses (day 43) and 250 µg level (18 days) after one dose (29 days). ~ 55 years old) available. A dose-dependent increase in immunogenicity was seen across all three dose levels and within the 25 µg and 100 µg dose levels during priming and boosting. All participants were 18 to 55 years old (n = 15 per cohort) and were seroconverted by day 15 post single dose at all three dose levels. Levels of bound antibody were observed in convalescent sera (blood samples of people who recovered from COVID-19) at a dose level of 25 µg (n = 15) on day 43, two weeks after the second day of dosing. It was the level that was played. Same assay. On day 43, at a dose level of 100 µg (n = 10), bound antibody levels were significantly higher than those found in convalescent sera. Samples for the remaining participants are not yet available.

At this time, neutralizing antibody data are only available for the first four participants in the 25 µg and 100 µg dose level cohorts. Consistent with the bound antibody data, mRNA-1273 vaccination elicited neutralizing antibodies in all eight of these participants. It is measured by the plaque reduction neutralization (PRNT) assay for live SARS-CoV-2. Levels of neutralizing antibody on day 43 were above those commonly found in convalescent sera.

mRNA-1273 is generally safe and well tolerated, with a safety profile consistent with that seen in previous clinical trials of the Moderna vaccine. The only incidence of Grade 3 adverse events in the 25 µg and 100 µg dose cohorts was 100 µg single participant who experienced Grade 3 erythema (redness) around the injection site. So far, the most prominent adverse events have been seen only after the second dose at the 250 µg dose level, which consisted of three participants with systemic grade 3 symptoms. All adverse events are temporary and self-solving. No Grade 4 or serious adverse events have been reported.

Preclinical results of virus challenge studies in mice conducted in collaboration with NIAID and its academic partners are also available. In this study, vaccination with mRNA-1273 prevented viral replication in the lungs of SARS-CoV-2 challenged animals. Neutralization titers in Phase 1 clinical trial participants at dose levels of 25 µg and 100 µg were consistent with the neutralization titers protected in the mouse challenge model.

Based on the intermediate Phase 1 data, the Moderna-led Phase 2 study is modified to study two dose levels of 50 µg and 100 µg with the goal of selecting doses for important studies. The NIAID-led Phase 1 trial has been modified to include a cohort of dose levels of 50 µg across each of the three age groups. Moderna anticipates a Phase 3 dose of 25 µg to 100 µg and plans to launch a Phase 3 trial in July, subject to the final decision of the clinical trial protocol.

“These interim data from Phase 1 show that, in the early stages, vaccination with mRNA-1273 elicits a magnitude immune response triggered by natural infections starting at doses as low as 25 µg.” Tal Zaks, MD, says. Chief medical officer of Moderna. “When combined with successful viral replication protection in the lung of a preclinical challenge model at doses that elicited similar levels of neutralizing antibodies, these data suggest that mRNA-1273 may prevent COVID-19 disease It supports our belief that it improves our ability to select doses for important trials. “

“ Today’s positive provisional Phase 1 data and positive data from the mouse challenge model allow the Moderna team to continue to focus on moving as quickly as possible, launching an important Phase 3 study in July, and if successful, Submits a BLA, ”said Stephan Vansel, CEO of Moderna. “We are investing to scale up manufacturing so that we can maximize the number of doses that can be generated to protect as many people as possible from SARS-CoV-2.”

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