Duration of immunogenicity of high-dose and prolonged-schedule hepatitis B vaccine among patients with chronic kidney disease: A one year follow-up study in China

ABSTRACT

Background

Patients with chronic kidney disease (CKD) have immunological defects that result in reduced production and faster decay of anti-HBs after hepatitis B vaccination. We assessed the duration of the immunogenicity after four-standard-dose and four-triple-dose regimens among patients with CKD.

Methods

A randomized controlled trial was conducted between May 2019 and February 2020. Patients were randomly allocated to receive three or four doses of 20 µg    , or four doses of 60 µg   of hepatitis B vaccine. Immunogenicity was assessed for 18 months till February 2021.

Results

Between months 7 and 18, the seroconversion rate decreased from 81.7% (58/71) to 64.3% (36/56) in IM20 × 3 group, from 93.0% (66/71) to 77.4% (41/53) in IM20 × 4 group, and from 93.2% (68/73) to 90.7% (49/54) in IM60 × 4 group. Seroconversion was higher in IM60 × 4 group than in IM20 × 3 group at month 18 (P < 0.05). In multivariate analysis, CKD patients without immune suppression or hormone therapy or patients with IM60 × 4 were more likely to have durable immunogenicity at month 18.

Conclusions

Patients receiving four-triple-dose regimen of hepatitis B vaccine showed improved duration of immunogenicity at the one-year follow-up.

Clinical trial registration

ClinicalTrials.gov (NCT03962881).

KEYWORDS:

• Chronic kidney disease
• duration of immunogenicity
• hepatitis B vaccine
• high-dose
• prolonged-schedule
• seroconversion

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.

Author contributions

Yujie Han: conceptualization, conceived and designed the study, reviewed and interpreted data, analyzed the data, wrote the manuscript. Na Cao: conceived and designed the study, reviewed and interpreted data. Xiaoxiao Lu: analyzed the data, reviewed and interpreted data. Tian Yao, Jing Shi, Yuanting Wu, Shuang Dong, Zhihong Shao, Jianmin Wang, Hongting Liu, Hongping Guo, Guowei Chai, Liming Liu: investigated and performed experiments. Fuzhen Wang: conceptualization of manuscript, writing-review & editing. Yongliang Feng* & Xiaofeng Liang* & Suping Wang*: conceptualization, conceived and designed the study, reviewed and interpreted data, writing-review & editing.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14760584.2022.2112951

Additional information

Funding

The study was funded by the National Science and Technology Major Project of the Ministry of Science and Technology of the People’s Republic of China under Grant [2018ZX10721202], the Key Research and Development Program of Science and Technology of Linfen under Grant [2136], the Key Research and Development Program of Lvliang under Grant [2020SHFZ52].