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

Carol M. Kao, Christina A. Rostad, Lauren E. Nolan, Etza Peters, Jennifer Kleinhenz, Jacob D. Sherman, Ashley Tippett, J. Wai Kuo Shih, Inci Yildirim, Vivien Agbakoba, Tatiana Beresnev, Cassandra Ballou, Satoshi Kamidani, Vinit Karmali, Muktha Natrajan, Erin M. Scherer, Nadine Rouphael, Evan J. Anderson

Research output: Contribution to journalArticlepeer-review

6 Scopus citations

Abstract

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.

Original languageEnglish
Pages (from-to)1093-1101
Number of pages9
JournalJournal of Infectious Diseases
Volume230
Issue number5
DOIs
StatePublished - Nov 15 2024

Keywords

  • acute hepatitis
  • hepatitis E
  • immunization
  • vaccination
  • viral hepatitis

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