Safety and Immunogenicity of Influenza A/H5N8 Virus Vaccine in Healthy Adults: Durability and Cross-reactivity of Antibody Responses.

Autor:	Neuzil KM; Center for Vaccine Development and Global Health, University of Maryland, Baltimore, MD, USA., Anderson EJ; Departments of Pediatrics and Medicine, Emory University School of Medicine, Atlanta, GA, USA., Frenck RW; Cincinnati Children's Hospital, Cincinnati, OH, USA., Frey SE; Center for Vaccine Development, Saint Louis University, St. Louis, MO, USA., Walter EB; Duke Human Vaccine Institute, Duke University School of Medicine, Durham, NC, USA., Rupp R; Sealy Institute for Vaccine Sciences, University of Texas Medical Branch, Galveston, TX, USA., Rotrosen ET; Center for Vaccine Development and Global Health, University of Maryland, Baltimore, MD, USA., Rouphael NG; Emory Vaccine Center, Emory University School of Medicine, Atlanta, GA, USA., Brady RC; Cincinnati Children's Hospital, Cincinnati, OH, USA., Graham I; Center for Vaccine Development, Saint Louis University, St. Louis, MO, USA., Schmader KE; Department of Medicine, Duke University School of Medicine, Durham, NC, USA., Porterfield L; Sealy Institute for Vaccine Sciences, University of Texas Medical Branch, TX, USA., Ortiz JR; Center for Vaccine Development and Global Health, University of Maryland, Baltimore, MD, USA., Swamy GK; Department of Obstetrics and Gynecology, Duke University School of Medicine, Durham, NC, USA., El Sahly HM; Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA., Jeevan T; St. Jude Children's Research Hospital, Memphis, TN, USA., Sitaula R; The Emmes Company, Rockville, MD, USA., Wegel A; The Emmes Company, Rockville, MD, USA., Webby RJ; St. Jude Children's Research Hospital, Memphis, TN, USA., Bryant C; The Emmes Company, Rockville, MD, USA.
Jazyk:	angličtina
Zdroj:	Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [Clin Infect Dis] 2023 Jan 05. Date of Electronic Publication: 2023 Jan 05.
DOI:	10.1093/cid/ciac982
Abstrakt:	Background: Influenza A/H5N8 viruses infect poultry and wild birds in many countries. In 2021, the first human A/H5N8 cases were reported. Methods: We conducted a phase I, cohort-randomized, double-blind, controlled trial of inactivated influenza A/H5N8 vaccine (clade 2.3.4.4c) administered with or without adjuvant. Cohort 1 subjects received either two doses of AS03-adjuvanted vaccine containing 3.75 μg or 15 μg hemagglutinin (HA); two doses of 15 μg HA unadjuvanted vaccine; or one dose of AS03-adjuvanted vaccine (3.75 μg or 15 μg HA), followed by one dose of non-adjuvanted vaccine (same HA content). Cohort 2 subjects received two doses of MF59-adjuvanted vaccine containing 3.75 μg or 15 μg HA, or 15 μg HA of non-adjuvanted vaccine. Subjects were followed for 13 months for safety and immunogenicity. Results: We enrolled 386 adult subjects in good health. Solicited adverse events were generally mild and more common among subjects who received adjuvanted vaccines. Antibody responses (hemagglutination inhibition or microneutralization assays) were highest in the two-dose AS03 group, followed by the one-dose AS03 group, the MF59 groups, and the non-adjuvanted groups. Antibody levels returned to baseline 12 months after the second vaccination in all groups except the 15 μg AS03-adjuvanted group. Cross-reactive antibodies to clade 2.3.4.4b strains isolated from recent human cases were demonstrated in a subset of both 15 μg adjuvanted groups. Conclusions: Two doses of influenza A/H5N8 vaccine were well-tolerated. Immunogenicity improved with receipt of two doses of adjuvanted vaccine and higher antigen content. (Funded by the National Institute of Allergy and Infectious Diseases. (© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
Databáze:	MEDLINE
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