Liao Z, Feng X W, Liu X E, Zhou Y S, Wen H R, Peng S H, Zhang Y X, Xu B, Zhuang H, Chen H Y
Nanchang Municipal Center for Disease Control and Prevention, Nanchang 330038, China.
Department of Microbiology and Parasitology, School of Basic Medical Sciences, Peking University Health Science Center, Beijing 100083, China.
Zhonghua Liu Xing Bing Xue Za Zhi. 2017 May 10;38(5):625-628. doi: 10.3760/cma.j.issn.0254-6450.2017.05.013.
To evaluate the safety and immunogenicity of one booster dose of inactivated hepatitis A vaccine in young adults. The subjects were selected from participants in the clinical trial of immunogenicity of inactivated and attenuated live hepatitis A vaccine in young adults. Eligible subjects were those who had received one dose of inactivated or attenuated hepatitis A vaccine, could be contacted and were sero-negative before primary vaccination. All qualified subjects were immunized with one booster dose of inactivated hepatitis A vaccine. The blood samples were collected before booster dose vaccination and 28 days after the immunization. Anti-HAV antibody titer ≥20 mIU/ml was considered to be sero-protected against hepatitis A virus. The GMCs in the inactivated HAV vaccine group and attenuated live vaccine group before booster dose vaccination were 70.80 mIU/ml and 50.12 mIU/ml, respectively, and the sero-protection rates were 94.7 and 65.0, respectively. After the vaccination of the booster dose, the sero-protection rates in both groups were 100.0, and the GMCs were 2 816.09 mIU/ml and 2 654.55 mIU/ml, respectively. The GMCs and sero-protection rates of anti-HAV antibody in young adults declined after three years of the primary vaccination. However, the higher GMC and sero-protection rate were observed in the inactivated vaccine group than in the attenuated live vaccine group. Significant increases of GMC levels were observed in both groups after one booster dose vaccination.
评估一剂次灭活甲型肝炎疫苗加强免疫在年轻成人中的安全性和免疫原性。研究对象选自年轻成人中灭活和减毒活甲型肝炎疫苗免疫原性临床试验的参与者。符合条件的受试者为已接种一剂次灭活或减毒甲型肝炎疫苗、能够被联系到且在初次接种前血清学阴性者。所有合格受试者均接种一剂次灭活甲型肝炎疫苗加强针。在加强针接种前及接种后28天采集血样。抗-HAV抗体滴度≥20 mIU/ml被认为对甲型肝炎病毒具有血清学保护作用。灭活HAV疫苗组和减毒活疫苗组在加强针接种前的几何平均浓度(GMC)分别为70.80 mIU/ml和50.12 mIU/ml,血清学保护率分别为94.7%和65.0%。加强针接种后,两组的血清学保护率均为100.0%,GMC分别为2816.09 mIU/ml和2654.55 mIU/ml。年轻成人在初次接种三年后抗-HAV抗体的GMC和血清学保护率下降。然而,灭活疫苗组的GMC和血清学保护率高于减毒活疫苗组。在接种一剂次加强针后,两组的GMC水平均显著升高。