美沙酮维持治疗人群短程高剂量乙型肝炎疫苗接种的免疫原性、安全性和依从性

Immunogenicity,safety and compliance with rapid,high-dose hepatitis B vaccination of individuals receiving methadone maintenance treatment

目的探讨美沙酮维持治疗(Methadone maintenance treatment,MMT)人群短程高剂量乙型肝炎肝疫苗(HepB)接种的免疫原性、安全性和依从性。方法在广西壮族自治区3所美沙酮门诊招募18-70岁MMT人群,随机分为短程高剂量组(A组)和常规方案组(B组),分别按0-1月程序接种60μg HepB和按0-1-6月程序接种20μg HepB,检测A组全程接种后5个月、B组第2剂接种后5个月(第3剂接种前)和全程接种后6个月的血清乙型肝炎表面抗体(HBsAb),观察每剂次接种后28d内不良反应,分析抗体阳性率和几何平均浓度(GMC)、不良反应发生率和全程接种完成率。结果A组、B组HepB全程接种后HBsAb阳性率分别为68.35%(54/79)、68.33%(41/60)(χ^(2)=0.00,P=0.998),强阳性率分别为34.18%(27/79)、21.67%(13/60)(χ^(2)=2.60,P=0.107),GMC分别为164.10mIU/mL、125.90mIU/mL(t=-0.74,P=0.463);B组第2剂接种后5个月HBsAb阳性率、强阳性率、GMC分别为71.08%(59/83)、21.69%(18/83)、130.50mIU/mL,与两组全程接种后结果均无显著性差异。两组总不良反应发生率分别为8.25%(8/97)和7.14%(7/98)(χ^(2)=0.08,P=0.772)。两组全程接种率分别为93.88%(92/98)和84.69%(83/98)(χ^(2)=4.32,P=0.038)。结论MMT人群短程高剂量HepB接种的免疫原性可能与常规方案相当,安全性较好,且依从性明显优于常规方案。

Objective To explore immunogenicity,safety,and compliance with a rapid-schedule,high-dose hepatitis B vaccine(HepB)administered to individuals receiving methadone maintenance treatment(MMT).Methods We recruited 18-70-year-olds receiving MMT from any of three MMT clinics in Guangxi Zhuang Autonomous Region.Subjects were randomly assigned to a rapid high-dose group(group A)or a standard regimen group(group B)for vaccination with either 60μg of HepB in a 0-1-month schedule or 20μg of HepB in a 0-1-6-month schedule.We tested sera for hepatitis B surface antibody(HBsAb)5 months after full-series vaccination in group A and 5 months after the second dose(before the third dose)and 6 months after full-series vaccination in group B.We observed for adverse reactions for 28 days after each dose.We analyzed HBsAb positivity rates and geometric mean concentrations(GMCs),incidences of adverse reactions,and coverage levels of full-series vaccination.Results HBsAb positivity rates after full-series vaccination were 68.35%(54/79)in group A and 68.33%(41/60)in group B(χ^(2)=0.00,P=0.998),with strongly positive rates being 34.18%(27/79)and 21.67%(13/60)(χ^(2)=2.60,P=0.107)and GMCs being 164.10 and 125.90 mIU/mL(t=-0.74,P=0.463).The HBsAb positivity rate,strongly positive rate,and GMC 5 months after the second dose were 71.08%(59/83),21.69%(18/83),and 130.50 mIU/mL,respectively,with no significant differences when comparing full-series vaccination of the two groups.Incidences of adverse reactions for the two groups were 8.25%(8/97)and 7.14%(7/98)(χ^(2)=0.08,P=0.772).Coverage levels of full-series vaccination for the two groups were 93.88%(92/98)and 84.69%(83/98)(χ^(2)=4.32,P=0.038).Conclusions Rapid,high-dose HepB vaccination of individuals receiving MMT had similar immunogenicity and safety and superior compliance compared to the standard HepB regimen.