Adherence and efficacy of the 0&#x2009;-&#x2009;7&#x2009;-&#x2009;21-day versus the 0&#x2009;-&#x2009;1&#x2009;-&#x2009;6-month hepatitis B vaccination schedules among people who use drugs: a two-year randomized controlled trial.

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

PubMed · 41622674

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.

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

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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).

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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. 2026-02-08. 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.. https://doi.org/10.1080/14760584.2026.2626920

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Journal Article; Randomized Controlled Trial; Comparative Study resource Adherence subject Adult subject China subject Comparative Study subject Drug Users subject Female subject Hepatitis B subject Hepatitis B Antibodies subject Hepatitis B Surface Antigens subject Hepatitis B Vaccines subject Humans subject Immunization Schedule subject Journal Article subject Male subject Middle Aged subject

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