Immune Memory Response After Booster of mRNA-1273 for SARS-CoV-2

 Laurence Chu, David Montefiori, Wenmei Huang, Biliana Nestorova, Ying Chang, Andrea Carfi, Darin K Edwards, Judy Oestreicher, Holly Legault, Bethany Girard, Rolando Pajon, Jacqueline M Miller, Rituparna Das, Brett Leav, Roderick McPhee

doi: https://doi.org/10.1101/2021.09.29.21264089

This article is a preprint and has not been certified by peer review [what does this mean?]. It reports new medical research that has yet to be evaluated and so should not be used to guide clinical practice.

PDF: https://www.medrxiv.org/content/10.1101/2021.09.29.21264089v1.full.pdf

Abstract

Rising breakthrough infections of coronavirus-2 (SARS-CoV-2) in previously immunized individuals has raised concerns for a potential booster to combat suspected waning immunity and new variants. In this study, participants immunized 6-8 months earlier with a primary series of two doses of 50 or 100 μg of mRNA-1273 were administered a booster injection of 50 μg of mRNA-1273. Neutralizing antibody levels at one month after the booster were 1.7-fold higher than those one-month post primary series second injection meeting the prespecified criteria for noninferiority, and indicating an immune memory response. The reactogenicity after the booster dose was similar to that after the second dose in the primary series of two doses of mRNA-1273 (50 or 100 μg) with no serious adverse events reported in the one-month follow-up period. These results demonstrate that a booster injection of mRNA-1273 in previously immunized individuals stimulated an immune response greater than the primary vaccination series.

Competing Interest Statement

Wenmei Huang, Ying Chang, Judy Oestreicher, Holly Legault, Biliana Nestorova, Bethany Girard, Rolando Pajon, Jacqueline M.Miller, Andrea Carfi, Darin K. Edwards, Rituparna Das, Brett Leav, and Roderick McPhee are employees of Moderna, Inc., and may hold stock/stock options in the company.

Clinical Trial

NCT04405076

Funding Statement

Parts A and B of the phase 2 trial (mRNA-1273 P201 trial/open-label extension; NCT04405076) were supported in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. 75A50120C00034, and Moderna, Inc.

https://www.medrxiv.org/content/10.1101/2021.09.29.21264089v1