Safety and immunogenicity of a phase 1/2 randomized clinical trial of a quadrivalent, mRNA-based seasonal influenza vaccine (mRNA-1010) in healthy adults: interim analysis.

Autor: Lee IT; Moderna, Inc., Cambridge, MA, USA., Nachbagauer R; Moderna, Inc., Cambridge, MA, USA. Raffael.Nachbagauer@modernatx.com., Ensz D; Meridian Clinical Research, Sioux City, IA, USA., Schwartz H; Research Centers of America, Hollywood, FL, USA., Carmona L; Moderna, Inc., Cambridge, MA, USA., Schaefers K; Moderna, Inc., Cambridge, MA, USA., Avanesov A; Moderna, Inc., Cambridge, MA, USA., Stadlbauer D; Moderna, Inc., Cambridge, MA, USA., Henry C; Moderna, Inc., Cambridge, MA, USA., Chen R; Moderna, Inc., Cambridge, MA, USA., Huang W; Moderna, Inc., Cambridge, MA, USA., Schrempp DR; Moderna, Inc., Cambridge, MA, USA., Ananworanich J; Moderna, Inc., Cambridge, MA, USA., Paris R; Moderna, Inc., Cambridge, MA, USA. Robert.Paris@modernatx.com.
Jazyk: angličtina
Zdroj: Nature communications [Nat Commun] 2023 Jun 19; Vol. 14 (1), pp. 3631. Date of Electronic Publication: 2023 Jun 19.
DOI: 10.1038/s41467-023-39376-7
Abstrakt: Despite vaccine availability, influenza remains a substantial global public health concern. Here, we report interim findings on the primary and secondary objectives of the safety, reactogenicity, and humoral immunogenicity of a quadrivalent messenger RNA (mRNA) vaccine against seasonal influenza, mRNA-1010, from the first 2 parts of a 3-part, first-in-human, phase 1/2 clinical trial in healthy adults aged ≥18 years (NCT04956575). In the placebo-controlled Part 1, a single dose of mRNA-1010 (50 µg, 100 µg, or 200 µg) elicited hemagglutination inhibition (HAI) titers against vaccine-matched strains. In the active-comparator-controlled Part 2, mRNA-1010 (25 µg, 50 µg, or 100 µg) elicited higher HAI titers than a standard dose, inactivated seasonal influenza vaccine for influenza A strains and comparable HAI titers for influenza B strains. No safety concerns were identified; solicited adverse reactions were dose-dependent and more frequent after receipt of mRNA-1010 than the active comparator. These interim data support continued development of mRNA-1010.
(© 2023. The Author(s).)
Databáze: MEDLINE
Externí odkaz: