Post-licensure evaluation on safety and immunogenicity of freeze-dried live attenuated hepatitis A vaccine(H_2 strain) in clinical phase Ⅳ study
10.13200/j.cnki.cjb.004394
- VernacularTitle:冻干甲型肝炎减毒活疫苗（H_2株）上市后临床Ⅳ期试验安全性及免疫原性评价
- Author:
CHENG Cheng
- Publication Type:Journal Article
- Keywords:
Freeze-dried live attenuated hepatitis A vaccine(H_2 strain);
Clinical trials;
Safety;
Immunogenicity
- From:
Chinese Journal of Biologicals
2025;38(1):42-47
- CountryChina
- Language:Chinese
-
Abstract:
Objective To assess the post-licensure safety and immunogenicity of freeze-dried live attenuated hepatitis A vaccine(H_2 strain) in order to popularize it as an immunization program vaccine.Methods Totally 5 000 healthy infants and young children aged 18-24 months were injected with single dose of freeze-dried live attenuated hepatitis A vaccine, and the adverse events of 0-14 d after vaccination were monitored. Among them, 200 cases were selected into immunogenic subgroups, and the serum hepatitis A virus(HAV) specific IgG antibody(anti-HAV IgG) was measured 8 weeks before and after immunization.Results A total of 5 000 participants completed inoculation, and 4 999 participants completed safety observation, among which, 424 cases of adverse reactions were reported, and the incidence of solicited adverse reactions was 8. 48%. The common local solicited adverse reactions were redness, tenderness, itching, rash and swelling at the inoculation site, while the systemic adverse reactions were mainly fever and anorexia. The severity was mainly grade 1-2, and no serious adverse events related to the vaccine occurred. Among 200 immunogenic subgroups, 188 participants were included in the per protocol set(PPS), the seroconversion rate of anti-HAV IgG antibody was 98. 91% [95% confidence interval(CI): 96. 11%-99. 87%], with a geometric mean titer(GMT) of 83. 67 mIU/mL(95% CI: 77. 05-90. 85 mIU/mL).Conclusion A single dose freeze-dried live attenuated hepatitis A vaccine(H_2 strain) presents good safety and immunogenicity for infants and young children aged 18-24 months.
