| Autor: |
Joakim Øverbø, Asma Aziz, K Zaman, John Clemens, Cathinka Halle Julin, Firdausi Qadri, Kathrine Stene-Johansen, Rajib Biswas, Shaumik Islam, Taufiqur Rahman Bhuiyan, Warda Haque, Synne Sandbu, Manzoor E Elahee, Mohammad Ali, Jennifer L Dembinski, Susanne Dudman |
| Rok vydání: |
2023 |
| Předmět: |
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| Zdroj: |
Vaccine |
| ISSN: |
0264-410X |
| DOI: |
10.1016/j.vaccine.2022.12.064 |
| Popis: |
Background Hepatitis E virus (HEV) is a major cause of acute viral hepatitis worldwide and it contributes to considerable maternal and neonatal mortality and morbidity in many low-income countries like Bangladesh. A three-dose regimen of a vaccine against HEV (HEV 239) has shown promising results in China. The effects and safety of this vaccine in other populations and with different dosing regimens remains uncertain. Objectives Investigate the immune response and safety of a two-dose regimen with the HEV 239 vaccine among healthy adults. Examine the feasibility of conducting a larger HEV 239 vaccine trial in rural Bangladesh. Methods One-hundred healthy men and non-pregnant women 16–39 years old were randomized in a 1:1 ratio to receive two doses of either the study (HEV) or control (Hepatitis B virus, HBV) vaccine (at 0, 1 month). Blood samples were collected at day 0, day 60 and 2 years after vaccination. The primary endpoints were the proportion and severity of adverse events up to 2 months after dose one and the longitudinal shift in anti-HEV IgG levels from day 0 to day 60 and 2 years after vaccination. Results Adverse events to HEV 239 were comparable to the control vaccine, mild in severity and resolved within one to nine days. All participants in the study group seroconverted and achieved high levels of HEV IgG antibodies that remained positive for two years in all but one. A T-cell response was detected one month after HEV 239 vaccination. Conclusion Our results show that two doses of the HEV 239 vaccine produces broad and likely functional immune responses against HEV that remain for at least two years. The safety profile was acceptable and a phase four study of HEV 239 in rural Bangladesh is feasible. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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