A Phase 1, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate the Safety and Immunogenicity of HEV-239 (Hecolin) Vaccine in Healthy US Adults.

Autor:	Kao CM; Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia, USA.; Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, Atlanta, Georgia, USA., Rostad CA; Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia, USA.; Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, Atlanta, Georgia, USA., Nolan LE; Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia, USA., Peters E; Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia, USA., Kleinhenz J; Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia, USA.; Hope Clinic, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA., Sherman JD; Hope Clinic, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA., Tippett A; Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia, USA., Shih JWK; Xiamen Innovax Biotech Company Limited, Xiamen, China., Yildirim I; Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia, USA.; Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, Atlanta, Georgia, USA., Agbakoba V; Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, Maryland, USA., Beresnev T; Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, Maryland, USA., Ballou C; The Emmes Company, LLC, Rockville, Maryland, USA., Kamidani S; Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia, USA.; Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, Atlanta, Georgia, USA., Karmali V; Hope Clinic, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA., Natrajan M; Hope Clinic, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA., Scherer EM; Hope Clinic, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA., Rouphael N; Hope Clinic, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA., Anderson EJ; Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia, USA.; Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, Atlanta, Georgia, USA.
Jazyk:	angličtina
Zdroj:	The Journal of infectious diseases [J Infect Dis] 2024 Nov 15; Vol. 230 (5), pp. 1093-1101.
DOI:	10.1093/infdis/jiae148
Abstrakt:	Background: Establishing the safety and immunogenicity of a hepatitis E virus vaccine in multiple populations could facilitate broader access and prevent maternal and infant mortality. Methods: We conducted a phase 1, randomized, double-blinded, placebo-controlled (4:1 vaccine to placebo) trial of 30 µg HEV-239 (Hecolin, Xiamen Innovax Biotech Company Limited, China) administered intramuscularly in healthy US adults aged 18-45 years. Participants were vaccinated on days 1, 29, and 180. Participants reported solicited local and systemic reactions for 7 days following vaccination and were followed through 12 months after enrollment for safety and immunogenicity (IgG, IgM). Results: Solicited local and systemic reactions between treatment and placebo group were similar and overall mild. No participants experienced serious adverse events related to HEV-239. All participants receiving HEV-239 seroconverted at 1 month following the first dose and remained seropositive throughout the study. HEV-239 elicited a robust hepatitis E IgG response that peaked 1 month following the second dose (geometric mean concentration [GMC], 6.16; 95% confidence interval [CI], 4.40-8.63), was boosted with the third dose (GMC, 11.50; 95% CI, 7.90-16.75) and persisted through 6 months. Conclusions: HEV-239 is safe and elicits a durable immune response through at least 6 months after the third dose in healthy US adults. Clinical Trials Registration: NCT03827395. Competing Interests: Potential conflicts of interest. E. J. A has consulted for Pfizer, Sanofi Pasteur, GSK, Janssen, Moderna, and Medscape; serves on a safety monitoring board for Kentucky BioProcessing, Inc and Sanofi Pasteur; serves on a data adjudication board for WCG and ACI Clinical; and is now an employee of Moderna, Inc. His institution receives funds to conduct clinical research unrelated to this article from MedImmune, Regeneron, PaxVax, Pfizer, GSK, Merck, Sanofi-Pasteur, Janssen, and Micron; and has received funding from NIH to conduct clinical trials of coronavirus disease 2019 (COVID-19) vaccines. He is now an employee of Moderna. N. R. has consulted for EMMES, Moderna, and ICON; and her institution receives funds to conduct clinical research unrelated to this article from Pfizer, Sanofi, Quidel, Lilly, and Merck; and from NIH to conduct translational clinical studies and interventional clinical trials. C. A. R.'s institution has received funds to conduct clinical research unrelated to this article from the Centers for Disease Control and Prevention (CDC), BioFire Inc, GSK, MedImmune, Janssen, Merck, Moderna, Novavax, PaxVax, Pfizer, Regeneron, Sanofi-Pasteur; and she is coinventor of patented RSV vaccine technology, which has been licensed to Meissa Vaccines, Inc. S. K.'s institution has received funding from the NIH to conduct clinical trials of Moderna and Janssen COVID-19 vaccines; and funding from Pfizer to conduct clinical trials of Pfizer-BioNTech COVID-19 vaccines. C. M. K's institution has received funds to conduct clinical research unrelated to this article from the CDC, Pfizer, and Merck, and the NIH to conduct clinical trials of the Moderna COVID-19 vaccine. E. M. S.'s institution has received funding from the NIH to conduct nonclinical studies on vaccine mechanisms of antibody durability. I. Y. consults for Merck and Sanofi-Pasteur; and has received funding to her institution to conduct clinical research unrelated to this article from the Gates Foundation, CDC, Moderna, and Pfizer. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed. (© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)
Databáze:	MEDLINE
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