Department of General Practice, First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Department of Scientific Research, Women's Hospital, School of Medicine Zhejiang University, Hangzhou, China.
Hum Vaccin Immunother. 2022 Nov 30;18(5):2061247. doi: 10.1080/21645515.2022.2061247. Epub 2022 May 4.
Vaccination remains the most effective and cost-saving measure to protect against hepatitis B, a global health problem. It is crucial to characterize the persistence of the immune response after booster vaccination. This study aimed to quantify the persistence through mathematical modeling. Booster vaccination against hepatitis B was conducted in children 5-15 years in 2009-10 in Zhejiang Province. There were four dosage formulations of hepatitis B vaccines [Shenzhenkangtai Biotechnology Co. Ltd. Dalianhanxin Biotechnology Co. Ltd. NCPC GeneTech Biotechnology Pharmaceutical Co. Ltd. Sinovac Biotech Co. LTD. China]: 5, 10, and 20 μg hepatitis B vaccines or 5 μg hepatitis A and B (HAB) combination vaccine with a 0-1-6-month schedule. These were randomly administered to children negative for all hepatitis B markers, named as the schedule 2 group. Anti-HBs positive subjects were given one dose of booster, named as the schedule 1 group. Anti-HBs antibody was measured 1, 7, 18, 66, and 102 months after the first booster dose. A linear mixed-effects model was proposed to predict long-term persistence. One hundred two months after the booster dose, the mean anti-HBs levels were 33.8 mIU/mL, with 73.7 mIU/mL for the schedule 1 group and 20.2 mIU/mL for the schedule 2 group. The model predicted that 99.5% of subjects would remain seropositive (≥10mIU/mL) at year 20 post booster vaccination, with 100.0% and 98.8% for the schedule 1 group and the schedule 2 group, respectively, whereas at year 30, the seropositivity rates would decrease to 76.8%, with 99.4% for the schedule 1 group and 62.5% for the schedule 2 group. The immunogenicity of the booster vaccination could persist for at least 8 years. Mathematical modeling may predict even longer, up to 30 years of protection.
接种疫苗仍然是预防乙型肝炎这一全球健康问题的最有效和最具成本效益的措施。描述加强免疫后的免疫反应持久性至关重要。本研究旨在通过数学建模来量化这种持久性。2009-2010 年，浙江省对 5-15 岁儿童进行了乙型肝炎加强免疫。使用了 4 种乙肝疫苗剂型[深圳康泰生物制品股份有限公司、大连汉信生物制药有限公司、中国生物技术股份有限公司、北京科兴中维生物技术有限公司]：5、10 和 20μg 乙肝疫苗或 5μg 乙肝和甲型肝炎（HAB）联合疫苗，免疫程序为 0-1-6 个月。这些疫苗随机分配给所有乙型肝炎标志物均为阴性的儿童，称为方案 2 组。抗-HBs 阳性者给予一剂加强免疫，称为方案 1 组。在第一次加强剂量后 1、7、18、66 和 102 个月测量抗-HBs 抗体。提出了一个线性混合效应模型来预测长期持久性。加强免疫后 102 个月，平均抗-HBs 水平为 33.8 mIU/mL，方案 1 组为 73.7 mIU/mL，方案 2 组为 20.2 mIU/mL。该模型预测，99.5%的受试者在加强免疫后 20 年仍保持血清阳性（≥10mIU/mL），方案 1 组和方案 2 组分别为 100.0%和 98.8%，而在 30 年时，血清阳性率将下降至 76.8%，方案 1 组为 99.4%，方案 2 组为 62.5%。加强免疫的免疫原性至少可维持 8 年。数学建模可能预测甚至更长时间，长达 30 年的保护。
