甲型肝炎减毒活疫苗（H2株）在人体中的安全性和免疫原性。

Safety and immunogenicity of live attenuated hepatitis A virus vaccine (H2 strain) in humans.

作者信息

Ran L A, Wang D Z, Duan Q Y, Yan T Y, Liu Q L, Luo Y G, Yang D Z, Yang D F, Xiao Z, Xie Q J

机构信息

Health and Anti-Epidemic Station of Sichuan Province, Chengdu.

出版信息

Chin Med J (Engl). 1993 Aug;106(8):604-7.

PMID:8222910

Abstract

A study was made in Neijiang City, Sichuan Province to observe the safety and immunogenicity of a live attenuated hepatitis A virus (HAV) vaccine (H2 strain). 3,031 children, aged 6 to 9 years, were injected subcutaneously with 10(6.0) TCID50, 10(5.5) TCID50, and 10(5.0) TCID50 of HAV vaccine; the seroconversion rate and antibody GMT were 97.52%-90.68%, GMT = 1:5.19 +/- 1.90-1:3.36 +/- 1.94; 84.75%-76.27%, GMT = 1:4.29 +/- 1.96-1:2.0 +/- 2.67; 53.23%-51.61%, GMT = 1:2.57 +/- 1.89-1:1.68 +/- 1.41 respectively after 4 weeks to 12 months of inoculation. Forty-eight children in the control group were anti-HAV negative at 4, 8, and 12 weeks; 21 children in the oral group were not antibody positive 4 and 8 weeks after oral administration of the vaccine. The stool specimens of 3 of the 14 vaccinated children were HAA positive. The results suggest that the live attenuated HAV vaccine (H2 strain) is of good immunogenicity and safety.

摘要

在四川省内江市开展了一项研究，以观察甲型肝炎减毒活疫苗（H2株）的安全性和免疫原性。3031名6至9岁儿童分别皮下注射10(6.0)TCID50、10(5.5)TCID50和10(5.0)TCID50的甲型肝炎疫苗；接种后4周~~12个月，血清转化率和抗体几何平均滴度分别为97.52%~~90.68%，GMT = 1:5.19±1.90~~1:3.36±1.94；84.75%~~76.27%，GMT = 1:4.29±1.96~~1:2.0±2.67；53.23%~~51.61%，GMT = 1:2.57±1.89~1:1.68±1.41。对照组48名儿童在4、8和12周时抗-HAV阴性；口服组21名儿童在口服疫苗后4周和8周时抗体未呈阳性。14名接种疫苗儿童中有3名的粪便标本甲型肝炎抗原阳性。结果表明，甲型肝炎减毒活疫苗（H2株）具有良好的免疫原性和安全性。