Comparison of efficacy of hepatitis B vaccination during induction versus maintenance phase of chemotherapy in acute lymphoblastic leukemia: A nonrandomized clinical trial

Gopisree Peringeth, P. Mohan, R. Dhodapkar, B. Dubashi, R. Swaminathan
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Abstract

Background: Acute lymphoblastic leukemia (ALL) patients are susceptible to hepatitis B infection due to profound immunosuppression and repeated transfusions. However, the comparative effectiveness of hepatitis B vaccination in different phases of chemotherapy has not been studied. Aim: In this comparative interventional study (CTRI/2017/08/009402), vaccination in the induction phase (IP) was compared to that in the maintenance phase (MP). Materials and Methods: The participating ALL patients in both groups (29 per group) were vaccinated with double the dose of hepatitis B vaccine at 0, 1, and 2 months. The proportion of patients with seroprotective anti-hepatitis B surface titers (>10 IU/ml) was compared between the two groups after each dose. Results: The seroprotection rates between both the phases were similar following the first (relative risk [RR] = 4, confidence interval [CI]: 0.47–33.65) and third (RR = 1.4, CI: 0.73-2.84) doses of vaccination, whereas following the second dose of vaccination, the seroprotection rate in IP was significantly higher than that of MP (RR = 1.9, CI: 1.07–3.35). Conclusion: This study concluded that a 0, 1, and 2 schedule of hepatitis B vaccination has similar efficacy in both the IP and the MP of chemotherapy in ALL patients. As the IP has a higher trend of seroprotection rates compared to MP, vaccination in IP followed by revaccination postchemotherapy may be preferred in countries with a high prevalence of hepatitis B infection.
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乙型肝炎疫苗在急性淋巴细胞白血病化疗诱导期和维持期的疗效比较:一项非随机临床试验
背景:急性淋巴细胞白血病(ALL)患者由于严重的免疫抑制和反复输血,容易感染乙型肝炎。然而,乙型肝炎疫苗在不同化疗阶段的比较有效性尚未得到研究。目的:在这项比较介入研究(CTRI/2017/08/009402)中,将诱导期(IP)的疫苗接种与维持期(MP)的疫苗注射进行比较。材料和方法:两组(每组29例)的ALL患者在0、1和2个月时接种双倍剂量的乙型肝炎疫苗。比较两组在每次给药后血清保护性抗乙型肝炎表面滴度(>10IU/ml)的患者比例。结果:接种第一剂疫苗(相对风险[RR]=4,置信区间[CI]:0.47–33.65)和第三剂疫苗(RR=1.4,置信区间0.73-2.84)后,两个阶段的血清保护率相似,而接种第二剂疫苗后,IP的血清保护率显著高于MP(RR=1.9,CI:1.07-3.35)。结论:本研究得出结论,0、1和2方案的乙肝疫苗接种对ALL患者的IP和化疗MP具有相似的疗效。与MP相比,IP具有更高的血清保护率趋势,因此在乙型肝炎感染率高的国家,IP疫苗接种后再进行血液治疗可能是首选。
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