| Autor: |
Gale Smith, Vivek Shinde, Rongman Cai, Nan Wang, Sapeckshita Agrawal, Michael J. Massare, Cheryl Keech, Gregory M. Glenn, Haixia Zhou, Joyce S. Plested, Jamie Fiske, Bin Zhou, Louis Fries, Mingzhu Zhu, Xuan Pham, Nita Patel, Maggie Lewis, Iksung Cho, Patricia Price-Abbott, Shane Cloney-Clark |
| Rok vydání: |
2020 |
| Předmět: |
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| DOI: |
10.1101/2020.08.07.20170514 |
| Popis: |
BackgroundImproved seasonal influenza vaccines for older adults are urgently needed, which can induce broadly cross-reactive antibodies and enhanced T-cell responses, particularly against A(H3N2) viruses, while avoiding egg-adaptive antigenic changes.MethodsWe randomized 2654 clinically-stable, community-dwelling adults ≥65 years of age 1:1 to receive a single intramuscular dose of either Matrix-M-adjuvanted quadrivalent nanoparticle influenza vaccine (qNIV) or a licensed inactivated influenza vaccine (IIV4) in this randomized, observer-blinded, active-comparator controlled trial conducted during the 2019-2020 influenza season. The primary objectives were to demonstrate the non-inferior immunogenicity of qNIV relative to IIV4 against 4 vaccine-homologous strains, based on Day 28 hemagglutination-inhibiting (HAI) antibody responses, described as geometric mean titers and seroconversion rate difference between treatment groups, and to describe the safety of qNIV. Cell-mediated immune (CMI) responses were measured by intracellular cytokine analysis.FindingsqNIV demonstrated immunologic non-inferiority to IIV4 against 4 vaccine-homologous strains as assessed by egg-based HAI antibody responses. Corresponding wild-type HAI antibody responses by qNIV were significantly higher than IIV4 against all 4 vaccine-homologous strains (22-66% increased) and against 6 heterologous A(H3N2) strains (34-46% increased), representing multiple genetically and/or antigenically distinct clades/subclades (all p-values InterpretationqNIV was well tolerated and produced a qualitatively and quantitatively enhanced humoral and cellular immune response in older adults. These enhancements may be critical to improving the effectiveness of currently licensed influenza vaccines.FundingNovavax. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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