Long-term durability of immunogenicity induced by standard and triple-dose hepatitis B vaccine in patients receiving methadone maintenance treatment

ABSTRACT

Objectives

We explored the long-term immunogenicity induced by 60 μg and 20 μg hepatitis B vaccines among patients receiving methadone maintenance treatment (MMT).

Methods

In initial study, a randomized controlled trial was conducted, in which patients receiving MMT were administered 20 µg (IM20 group) or 60 µg (IM60 group) hepatitis B vaccines at months 0, 1, and 6. In this study, the responders at month 7 were followed-up at months 18, 30, and 42 to estimate long-term immunogenicity.

Results

The response rate decreased from 78.0% (39/50) to 31.1% (14/45) in the IM20 group, and from 86.0% (43/50) to 50.0% (20/40) in the IM60 group from month 7 to 42. Vaccine-induced responses in 75% of patients were observed for 14.2 months in the IM20 group and for 20.0 months in the IM60 group, and differences between these two groups were non-significant (P > 0.05).

Conclusion

The three-dose 20 µg and 60 µg hepatitis B vaccines showed similar rapid hepatitis B surface antibody decreases.

Abbreviations: HBV, hepatitis B virus; MMT, methadone maintenance treatment; HCC, hepatocellular carcinoma; HBsAg, hepatitis B surface antigen; anti-HBs, hepatitis B surface antibody; HR, hazard ratio; CI, confidence interval; IQR, interquartile range; GEE, generalized estimated equation.

KEYWORDS:

• Hepatitis B vaccine
• methadone maintenance treatment
• randomized controlled trial
• long-term durability
• immunogenicity

Article highlights

• The response and high-level response rates in the IM60 group were numerically higher than those in the IM20 group at consecutive follow-up points, although these differences were not statistically significant.

• The duration of vaccine-induced responses in 75% of patients with anti-HBs ≥10 mIU/mL were 14.2 months in the IM20 group and 20.0 months in the IM60 group.

• The risk of response loss in patients aged ≥40 years was 2.09 times higher than that in patients aged <40 years.

• Kinetic profiles in the IM20 and IM60 groups were similar.

• No serious adverse events (SAEs) related to vaccination were reported at consecutive follow-up points.

Author contributions

Tian Yao: Project Design, Investigation, Data Collection, Data Curation, Data Analysis, Writing-Original Draft, Writing-Review & Editing; Yuanting Wu, Shuang Dong: Investigation, Data Collection, Data Curation, Data Analysis; Linying Gao, Shan Shi, Zhihong Shao, Lina Wu, Dan Feng, Jing Shi, Yawei Zhang: Data Curation, Data Analysis; Yongliang Feng, Xiaofeng Liang: Project administration; Suping Wang: Supervision.

Acknowledgments

We thank all MMT patients for participating in this study. We gratefully acknowledge the contribution from our colleagues and students, and doctors, nurses of the MMT clinic and personnel who contributed to this study.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose

Supplementary material

Supplemental data for this article can be accessed here.

Additional information

Funding

The study was funded by the National Science and Technology Major Project of the Ministry of Science and Technology of China (2018ZX10721202, 2012ZX10002001), Research Project Supported by Shanxi Scholarship Council of China (2013-056) and Construction Project of Characteristic Key Disciplines for Universities of Shanxi Province.