Adherence and efficacy of the 0 - 7 - 21-day versus the 0 - 1 - 6-month hepatitis B vaccination schedules among people who use drugs: a two-year randomized controlled trial.

IF 5.6 3区医学 Q1 IMMUNOLOGY

Expert Review of Vaccines Pub Date : 2026-12-01 Epub Date: 2026-02-08 DOI:10.1080/14760584.2026.2626920

Xianbin Hou, Ning Li, Hailan Zhang, Wenjun Liu, Haichao Zheng, Tianyi Zhuang, Zhuoru Zou, Ruyi Xia, Ying Liu, Hongyan Zhang, Tiejun Hou, Zhijun Chen, Baozhong Chen, Fuzhen Wang, Lirong Wang, Xiaoli Wei, Guihua Zhuang

{"title":"Adherence and efficacy of the 0 - 7 - 21-day versus the 0 - 1 - 6-month hepatitis B vaccination schedules among people who use drugs: a two-year randomized controlled trial.","authors":"Xianbin Hou, Ning Li, Hailan Zhang, Wenjun Liu, Haichao Zheng, Tianyi Zhuang, Zhuoru Zou, Ruyi Xia, Ying Liu, Hongyan Zhang, Tiejun Hou, Zhijun Chen, Baozhong Chen, Fuzhen Wang, Lirong Wang, Xiaoli Wei, Guihua Zhuang","doi":"10.1080/14760584.2026.2626920","DOIUrl":null,"url":null,"abstract":"Background: To compare the adherence and efficacy between the 0 - 7 - 21-day and the 0 - 1 - 6-month hepatitis B virus (HBV) vaccination schedules among people who use drugs (PWUD) in China.Research design and methods: A randomized controlled trial was conducted in 1261 HBV-susceptible PWUD from compulsory isolated detoxification centers (CIDCs) and methadone maintenance treatment (MMT) clinics in Xi'an. A 20 µg per-dose vaccine was used. HBV surface antibody (anti-HBs), surface antigen, and core antibody were tested at months 7, 15, and 22 after the first dose.Results: Third-dose coverage was significantly higher in the 0 - 7 - 21-day group (74.40%) than in the 0 - 1 - 6-month group (51.58%, p < 0.001), mainly driven by participants from CIDCs (77.75% vs. 45.69%). Anti-HBs positive rates at months 7, 15, and 22 among participants who completed all three doses were significantly higher for the 0 - 1 - 6-month schedule (90.71%, 76.82%, and 67.35%) than for the 0 - 7 - 21-day schedule (74.23%, 49.40%, and 40.95%; all p < 0.001). HBV infection incidence was similar between schedules, but significantly different between vaccinees and non-vaccinees (p = 0.018).Conclusions: The 0 - 7 - 21-day schedule substantially enhances three-dose completion in PWUD, but induces a notably weaker anti-HBs response and persistence. Schedules should be selected based on the management models for PWUD and their individual characteristics.Clinical trial registration: Chinese Clinical Trial Registry (ChiCTR1900022403).","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"2626920"},"PeriodicalIF":5.6000,"publicationDate":"2026-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Expert Review of Vaccines","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/14760584.2026.2626920","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2026/2/8 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"IMMUNOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Background: To compare the adherence and efficacy between the 0 - 7 - 21-day and the 0 - 1 - 6-month hepatitis B virus (HBV) vaccination schedules among people who use drugs (PWUD) in China.

Research design and methods: A randomized controlled trial was conducted in 1261 HBV-susceptible PWUD from compulsory isolated detoxification centers (CIDCs) and methadone maintenance treatment (MMT) clinics in Xi'an. A 20 µg per-dose vaccine was used. HBV surface antibody (anti-HBs), surface antigen, and core antibody were tested at months 7, 15, and 22 after the first dose.

Results: Third-dose coverage was significantly higher in the 0 - 7 - 21-day group (74.40%) than in the 0 - 1 - 6-month group (51.58%, p < 0.001), mainly driven by participants from CIDCs (77.75% vs. 45.69%). Anti-HBs positive rates at months 7, 15, and 22 among participants who completed all three doses were significantly higher for the 0 - 1 - 6-month schedule (90.71%, 76.82%, and 67.35%) than for the 0 - 7 - 21-day schedule (74.23%, 49.40%, and 40.95%; all p < 0.001). HBV infection incidence was similar between schedules, but significantly different between vaccinees and non-vaccinees (p = 0.018).

Conclusions: The 0 - 7 - 21-day schedule substantially enhances three-dose completion in PWUD, but induces a notably weaker anti-HBs response and persistence. Schedules should be selected based on the management models for PWUD and their individual characteristics.

Clinical trial registration: Chinese Clinical Trial Registry (ChiCTR1900022403).

查看原文本刊更多论文

在使用药物的人群中，0 - 7 - 21天与0 - 1- 6个月乙肝疫苗接种计划的依从性和有效性：一项为期两年的随机对照试验

背景：比较中国药物使用人群（PWUD）接种0 - 7 - 21天和0 - 1- 6个月乙型肝炎病毒（HBV）疫苗接种时间表的依从性和有效性。研究设计与方法：对西安市强制隔离戒毒中心和美沙酮维持治疗中心1261例hbv易感PWUD患者进行随机对照试验。每剂量使用20µg酿酒酵母重组疫苗。在第一次给药后7、15、22个月检测HBV表面抗体（anti-HBs）、表面抗原和核心抗体。结果：0 ~ 7 ~ 21天组第三剂覆盖率（74.40%）显著高于0 ~ 1 ~ 6个月组（51.58%,p p p = 0.018）。不同接种方案的疫苗相关不良反应率具有可比性。结论：0 - 7 - 21天的治疗方案显著提高了PWUD患者的三次给药完成率，但诱导的抗hbs反应和持续性明显减弱。时间表的选择应根据城市污水处理的管理模式和各自的特点。临床试验注册：中国临床试验注册中心（ChiCTR1900022403）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Expert Review of Vaccines 医学-免疫学

CiteScore

9.10

自引率

3.20%

发文量

136

审稿时长

4-8 weeks

期刊介绍： Expert Review of Vaccines (ISSN 1476-0584) provides expert commentary on the development, application, and clinical effectiveness of new vaccines. Coverage includes vaccine technology, vaccine adjuvants, prophylactic vaccines, therapeutic vaccines, AIDS vaccines and vaccines for defence against bioterrorism. All articles are subject to rigorous peer-review. The vaccine field has been transformed by recent technological advances, but there remain many challenges in the delivery of cost-effective, safe vaccines. Expert Review of Vaccines facilitates decision making to drive forward this exciting field.