tetano
Editor, Senior Moderator
Nat Commun
. 2023 Jun 19;14(1):3631.
doi: 10.1038/s41467-023-39376-7. 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
Ivan T Lee[SUP] 1 [/SUP], Raffael Nachbagauer[SUP] 2 [/SUP], David Ensz[SUP] 3 [/SUP], Howard Schwartz[SUP] 4 [/SUP], Lizbeth Carmona[SUP] 1 [/SUP], Kristi Schaefers[SUP] 1 [/SUP], Andrei Avanesov[SUP] 1 [/SUP], Daniel Stadlbauer[SUP] 1 [/SUP], Carole Henry[SUP] 1 [/SUP], Ren Chen[SUP] 1 [/SUP], Wenmei Huang[SUP] 1 [/SUP], Daniela Ramirez Schrempp[SUP] 1 [/SUP], Jintanat Ananworanich[SUP] 1 [/SUP], Robert Paris[SUP] 5 [/SUP]
Affiliations
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 Jun 19;14(1):3631.
doi: 10.1038/s41467-023-39376-7. 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
Ivan T Lee[SUP] 1 [/SUP], Raffael Nachbagauer[SUP] 2 [/SUP], David Ensz[SUP] 3 [/SUP], Howard Schwartz[SUP] 4 [/SUP], Lizbeth Carmona[SUP] 1 [/SUP], Kristi Schaefers[SUP] 1 [/SUP], Andrei Avanesov[SUP] 1 [/SUP], Daniel Stadlbauer[SUP] 1 [/SUP], Carole Henry[SUP] 1 [/SUP], Ren Chen[SUP] 1 [/SUP], Wenmei Huang[SUP] 1 [/SUP], Daniela Ramirez Schrempp[SUP] 1 [/SUP], Jintanat Ananworanich[SUP] 1 [/SUP], Robert Paris[SUP] 5 [/SUP]
Affiliations
- PMID: 37336877
- DOI: 10.1038/s41467-023-39376-7
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.