A Phase 1, Double-blinded, Placebo-Controlled Clinical Trial to Evaluate the Safety and Immunogenicity of HEV-239 (Hecolin®) Vaccine in Healthy US Adults,The Journal of Infectious Diseases

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A Phase 1, Double-blinded, Placebo-Controlled Clinical Trial to Evaluate the Safety and Immunogenicity of HEV-239 (Hecolin®) Vaccine in Healthy US Adults
The Journal of Infectious Diseases ( IF 6.4 ) Pub Date : 2024-03-28 , DOI: 10.1093/infdis/jiae148
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}

Affiliation

Introduction 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: 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 one month following the first dose and remained seropositive throughout the study. HEV-239 elicited a robust hepatitis E IgG response that peaked one month following the second dose (Geometric Mean Concentration (GMC) 6.16; 95% 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. Safety Study of Hepatitis E Vaccine (HEV239) - Full Text View - ClinicalTrials.gov

更新日期：2024-03-28

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