School of Public Health, Guangdong Pharmaceutical University, Guangzhou, 510310, China.
Heyuan Center for Disease Control and Prevention, Heyuan, China.
BMC Public Health. 2024 Sep 27;24(1):2641. doi: 10.1186/s12889-024-18779-1.
To assess the immunization efficacy and incidence of adverse reactions after hepatitis B vaccination in children with thalassemia based on data from real-world studies.
A total of 625 children were recruited into this cross-sectional study. Subgroup analyses of different thalassemia types were performed using binary logistic regression, the factors affecting HBsAb levels were identified using multiple linear regression, and the dose-response relationship between the duration of immunization and seroconversion was explored using the restricted cubic spline (RCS) model to further assess the protective duration of the hepatitis B vaccine.
HBsAb positivity in enrolled children was 87.3% in the thalassemia group and 81.4% in the control group. Multifactorial analysis revealed that the duration of immunization, age at completion of vaccination, and whether the first dose was delayed were significant factors influencing HBsAb levels in children (P < 0.05). The threshold for HBsAb positivity may be reached when the immunization duration reaches approximately 30 months. A subgroup analysis revealed that the HBsAb positivity rate was lower in children with β-thalassemia minor compared to those with α-thalassemia minor (P = 0.001, 95% CI: 0.097 ∼ 0.536). Adverse reactions after hepatitis B vaccination were dominated by general reactions, with a statistically significant difference in injection-site redness and swelling between the thalassemia and control groups (P < 0.05).
The immunization response to the hepatitis B vaccine in children with thalassemia minor was comparable to healthy children, with no abnormal adverse effects seen.
基于真实世界研究数据,评估乙型肝炎疫苗在地中海贫血患儿中的免疫效果和不良反应发生率。
本横断面研究共纳入 625 名儿童。采用二项逻辑回归对不同地中海贫血类型进行亚组分析,采用多元线性回归确定影响 HBsAb 水平的因素,并采用受限立方样条(RCS)模型探索免疫接种持续时间与血清转换之间的剂量-反应关系,进一步评估乙型肝炎疫苗的保护持续时间。
地中海贫血组儿童 HBsAb 阳性率为 87.3%,对照组为 81.4%。多因素分析显示,免疫接种持续时间、接种完成时的年龄以及首针是否延迟是影响儿童 HBsAb 水平的显著因素(P<0.05)。当免疫接种持续时间达到约 30 个月时,可能达到 HBsAb 阳性的阈值。亚组分析显示,与α地中海贫血相比,β地中海贫血轻型患儿的 HBsAb 阳性率较低(P=0.001,95%CI:0.097~0.536)。乙型肝炎疫苗接种后的不良反应以一般反应为主,地中海贫血组与对照组在注射部位红肿方面有统计学差异(P<0.05)。
地中海贫血轻型患儿对乙型肝炎疫苗的免疫反应与健康儿童相当,未见异常不良反应。