Xia Guoliang, Jia Zhiyuan, Yan Tianqiang, Li Rongcheng, Liu Hongbin, Xu Zhiyi, Cao Huilin, Liu Chongbai
Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing 100052, China.
Zhonghua Shi Yan He Lin Chuang Bing Du Xue Za Zhi. 2002 Jun;16(2):146-9.
To determine the long-term efficacy and persistence of Chinese infants after receiving only active plasma-derived hepatitis B vaccine, and to evaluate if providing booster vaccination after basic hepatitis B immunization is necessary.
Infants who were born in 1986-1988 in four demonstrative hepatitis B immunization trial areas of Hunan, Guangxi, Hebei and Shanghai after receiving only active plasma-derived hepatitis B vaccination, had been randomly followed up for 15 years. HBsAg,anti-HBs and anti-HBc in 21 680 person-times were tested using commercial SPRIA kits.
Prevalence of HBV carriers was less than 1.66% among all children vaccinated with only active plasma-derived hepatitis B vaccine in 4 clinical trial areas. Prevalence of HBsAg did not increase with years after vaccination,90%(95% Cl:83.1%-97.2%) effectiveness of hepatitis B vaccine persisted for 15 years in preventing chronic HBV infection. Carriage, HBV infection and efficacy were not different among all age groups (P>0.05). Seroprotection rate (anti-HBs?10 mIU/ml) and quantity of anti-HBs were significantly decreased with years after vaccination. Seroprotection rates of anti-HBs were 40%-50% and 30%-42% during the 9th-10th year and the 13th-14th ear of vaccination, respectively. Titer of anti-HBs declined?by 90% after 14 years.
These results showed that long-term efficacy of only active plasma-derived hepatitis B vaccination, which was not affected by decline in seroprotection rate and titer of anti-HBs. For children and adults whose immune status is normal, booster doses of vaccine are not recommended.
确定中国婴儿仅接种活性血浆源性乙肝疫苗后的长期疗效和持久性，并评估在乙肝基础免疫后进行加强免疫是否必要。
对1986 - 1988年在湖南、广西、河北和上海四个乙肝免疫示范试验区出生且仅接种活性血浆源性乙肝疫苗的婴儿进行随机随访15年。使用商用SPRIA试剂盒检测21680人次的HBsAg、抗-HBs和抗-HBc。
在4个临床试验地区，仅接种活性血浆源性乙肝疫苗的所有儿童中HBV携带者患病率低于1.66%。接种疫苗后数年，HBsAg患病率未增加，乙肝疫苗在预防慢性HBV感染方面90%（95%CI：83.1% - 97.2%）的有效性持续了15年。各年龄组的携带率、HBV感染率和疗效无差异（P>0.05）。接种疫苗后数年，血清保护率（抗-HBs≥10 mIU/ml）和抗-HBs量显著下降。接种疫苗第9 - 10年和第13 - 14年时抗-HBs血清保护率分别为40% - 50%和30% - 42%。14年后抗-HBs滴度下降了90%。
这些结果表明，仅接种活性血浆源性乙肝疫苗具有长期疗效，不受抗-HBs血清保护率和滴度下降的影响。对于免疫状态正常的儿童和成人，不建议接种加强剂量疫苗。
