AI Article Synopsis
- A phase 1 clinical trial tested the safety and immune response of the hepatitis E vaccine HEV-239 on healthy adults in the US, with participants receiving three doses over six months.
- Results showed that side effects were mild and similar between the vaccine and placebo groups, with no serious adverse events linked to the vaccine.
- The vaccine successfully generated a strong and lasting immune response, with all participants maintaining protective antibodies for at least six months after the final dose.
Article 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.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11565884 | PMC |
| http://dx.doi.org/10.1093/infdis/jiae148 | DOI Listing |
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