Expert Review of Vaccines ( IF 6.2 ) Pub Date : 2021-09-16 , DOI: 10.1080/14760584.2021.1977629 Yongliang Feng 1, 2 , Tian Yao 1, 2 , Yizhuo Gao 1, 2 , Hong Li 3 , Shuang Dong 1, 2 , Yuanting Wu 1, 2 , Yuan Liu 4 , Jing Li 4 , Chunhua Liu 4 , Jinxia Liu 5 , Tongchuan Xue 5 , Yuan Yuan 6 , Junhua Wu 6 , Fuzhen Wang 7 , Xiaofeng Liang 8 , Suping Wang 1, 2
ABSTRACT
Background
We evaluated the safety and immunogenicity of four doses of 20 or 60 µg, and the immunogenicity and compliance of the short-term vaccination regimen (0, 1, and 2 months) among patients receiving MMT.
Research design and methods
We conducted a randomized controlled trial among 303 patients receiving MMT who were randomized to receive 3 or 4 doses of 20 or 60 µg of recombinant hepatitis B vaccine.
Results
At month 7, the seroconversion rates in both IM20 × 4 and IM60 × 4 groups were numerically higher than the IM20 × 3 group (P > 0.05). The high-level responses and geometric mean concentration (GMC) of anti-HBs in both IM20 × 4 and IM60 × 4 groups were significantly higher than the IM20 × 3 group (P < 0.05). The completion rate of the short-term high-strength vaccination group was significantly higher than the standard vaccination group (P < 0.05), with similar immunogenicity (P > 0.05).
Conclusions
Both the high-strength and standard-strength four-dose hepatitis B vaccine regimens could improve the immune response for patients receiving MMT. The high-strength short-term vaccination regimen could improve compliance and attain comparable immunogenicity with the standard vaccination regimen. The high-strength short-term vaccination regimen is recommended and the fourth dose is encouraged for this population considering the compliance and immunogenicity.
Clinical trial registration
ClinicalTrials.gov (NCT03962816)
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