Shi Jing, Feng Yongliang, Gao Linying, Feng Dan, Yao Tian, Shi Shan, Zhang Yawei, Liang Xiaofeng, Wang Suping
School of Public Health, Shanxi Medical University, Taiyuan 030001, Shanxi, China.
Methadone Maintenance Treatment Clinic, Nanning Red Cross Hospital, Nanning, Guangxi, China.
Vaccine. 2017 Apr 25;35(18):2443-2448. doi: 10.1016/j.vaccine.2017.03.034. Epub 2017 Mar 23.
To explore whether the immunization with high-dose (60μg) hepatitis B vaccines in patients receiving methadone maintenance treatment (MMT) could yield a superior protection against hepatitis B infection than did the standard dose (20μg).
We conducted a randomized, double-blinded, parallel-controlled trial in MMT patients. Patients with serologically negative hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs) were randomized in a ratio of 1:1 to receive three intramuscular injections of 20μg or 60μg recombinant hepatitis B vaccine at months 0, 1, and 6. Serum HBsAg and anti-HBs were measured at months 7 and 12 post-vaccination to assess the immunogenicity.
A total of 196 MMT patients were randomized and 195 received at least one injection (98 and 97 in 20 and 60μg vaccine groups, respectively). The 60μg vaccine group showed a seroconversion of anti-HBs of 87.3%, high-level response rate of 56.3%, and GMC of 742.9mIU/mL at month 7. While these results were numerically higher than the 20μg group, a statistical difference was not found. HIV infection and concomitant drug abuse were negatively associated with the robust immune responses. 7.7% of MMT patients receiving at least one dose of vaccine reported solicited adverse reactions within 7days after vaccination, 2.6% reported unsolicited adverse reactions within 28days after vaccination. None of the MMT patients reported serious adverse events or became HBsAg positive during the follow-up.
The three-dose regimen of 60μg recombinant hepatitis B vaccine at months 0, 1, and 6 can yield a similar immunogenicity among MMT patients as compared to the 20μg vaccine. ClinicalTrials.gov identifier: NCT02991599.
探讨在接受美沙酮维持治疗（MMT）的患者中，高剂量（60μg）乙肝疫苗免疫接种是否比标准剂量（20μg）能提供更好的乙肝感染防护。
我们对MMT患者进行了一项随机、双盲、平行对照试验。乙肝表面抗原（HBsAg）和乙肝表面抗体（抗-HBs）血清学阴性的患者按1:1比例随机分组，在第0、1和6个月接受三次肌肉注射20μg或60μg重组乙肝疫苗。在接种疫苗后第7和12个月检测血清HBsAg和抗-HBs，以评估免疫原性。
共有196例MMT患者被随机分组，195例接受了至少一次注射（20μg疫苗组98例，60μg疫苗组97例）。60μg疫苗组在第7个月时抗-HBs血清转化率为87.3%，高水平应答率为56.3%，几何平均浓度（GMC）为742.9mIU/mL。虽然这些结果在数值上高于20μg疫苗组，但未发现统计学差异。HIV感染和同时存在药物滥用与强烈免疫反应呈负相关。7.7%接受至少一剂疫苗的MMT患者在接种后7天内报告了预期不良反应，2.6%在接种后28天内报告了非预期不良反应。在随访期间，没有MMT患者报告严重不良事件或变为HBsAg阳性。
与20μg疫苗相比，在第0、1和6个月接种三剂60μg重组乙肝疫苗在MMT患者中能产生相似的免疫原性。ClinicalTrials.gov标识符：NCT02991599。
