Academic Journal
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
| العنوان: | 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 |
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| المؤلفون: | Ivan T. Lee, Raffael Nachbagauer, David Ensz, Howard Schwartz, Lizbeth Carmona, Kristi Schaefers, Andrei Avanesov, Daniel Stadlbauer, Carole Henry, Ren Chen, Wenmei Huang, Daniela Ramirez Schrempp, Jintanat Ananworanich, Robert Paris |
| المصدر: | Nature Communications, Vol 14, Iss 1, Pp 1-11 (2023) |
| بيانات النشر: | Nature Portfolio |
| سنة النشر: | 2023 |
| المجموعة: | Directory of Open Access Journals: DOAJ Articles |
| مصطلحات موضوعية: | Science |
| الوصف: | 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. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 2041-1723 |
| Relation: | https://doi.org/10.1038/s41467-023-39376-7; https://doaj.org/toc/2041-1723; https://doaj.org/article/234959adb1584b539256d7f99380c3d4 |
| DOI: | 10.1038/s41467-023-39376-7 |
| الاتاحة: | https://doi.org/10.1038/s41467-023-39376-7 https://doaj.org/article/234959adb1584b539256d7f99380c3d4 |
| رقم الانضمام: | edsbas.32E9186C |
| قاعدة البيانات: | BASE |
Full Text Finder | تدمد: | 20411723 |
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| DOI: | 10.1038/s41467-023-39376-7 |