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Clinical Trial
. 2024 Nov 15;230(5):1093-1101.
doi: 10.1093/infdis/jiae148.

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  1   2 , Christina A Rostad  1   2 , Lauren E Nolan  1 , Etza Peters  1 , Jennifer Kleinhenz  1   3 , Jacob D Sherman  3 , Ashley Tippett  1 , J Wai Kuo Shih  4 , Inci Yildirim  1   2 , Vivien Agbakoba  5 , Tatiana Beresnev  5 , Cassandra Ballou  6 , Satoshi Kamidani  1   2 , Vinit Karmali  3 , Muktha Natrajan  3 , Erin M Scherer  3 , Nadine Rouphael  3 , Evan J Anderson  1   2
Affiliations
Clinical Trial

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 et al. J Infect Dis. .

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.

Clinical trials registration: NCT03827395.

Keywords: acute hepatitis; hepatitis E; immunization; vaccination; viral hepatitis.

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Conflict of interest statement

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.

Figures

Figure 1.
Figure 1.
CONSORT diagram. Abbreviations: HEV, hepatitis E virus; Ig, immunoglobulin; mITT, modified intention to treat; PP, per protocol.
Figure 2.
Figure 2.
Solicited local and systemic adverse reactions observed after receipt of HEV-239 or placebo.
Figure 3.
Figure 3.
Immunogenicity of HEV-239 versus placebo; immunoglobulin G (IgG) geometric mean concentration, modified intention-to-treat population.
See this image and copyright information in PMC

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References

    1. Kamar N, Bendall R, Legrand-Abravanel F, et al. . Hepatitis E. Lancet 2012; 379:2477–88. - PubMed
    1. Rein DB, Stevens GA, Theaker J, Wittenborn JS, Wiersma ST. The global burden of hepatitis E virus genotypes 1 and 2 in 2005. Hepatology 2012; 55:988–97. - PubMed
    1. Al-Shimari FH, Rencken CA, Kirkwood CD, Kumar R, Vannice KS, Stewart BT. Systematic review of global hepatitis E outbreaks to inform response and coordination initiatives. BMC Public Health 2023; 23:1120. - PMC - PubMed
    1. Taniguchi M, Kim SR, Mishiro S, et al. . Epidemiology of hepatitis E in Northeastern China, South Korea and Japan. J Infect 2009; 58:232–7. - PubMed
    1. Verghese VP, Robinson JL. A systematic review of hepatitis E virus infection in children. Clin Infect Dis 2014; 59:689–97. - PubMed

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