title: Immunogenicity and safety of high-dose hepatitis B vaccine among drug users: A randomized, open-labeled, blank-controlled trial.
abstract: Due to the low uptake, adherence, and completion of vaccination among drug users, and their compromised immune responses to hepatitis B vaccination, the current practice of hepatitis B vaccination may not provide optimal protection. The aim of this study was to evaluate the immunogenicity and safety of 60 µg and 20 µg hepatitis B vaccines among drug users. A randomized, open-labeled, blank-controlled trial was conducted among drug users at 2 drug rehabilitation centers in China. The eligible participants were drug users who were serologically negative for the hepatitis B surface antigen (HBsAg) and the hepatitis B surface antibody (anti-HBs). Participants were randomized in a ratio of 1:1:1 to receive 20 µg (IM20 group) or 60 µg (IM60 group) of hepatitis B vaccine or blank control at months 0, 1, and 6, and followed at months 6, 7, and 12. Seroconversion rates of 94.7% and 92.6% were observed in IM20 and IM60 groups at month 7, and correspondingly decreased to 89.5% and 91.7% respectively at month 12. The IM60 group showed significantly higher geometric mean concentrations (GMCs) of anti-HBs (2022.5 and 676.7 mIU mL-1) than the IM20 group did (909.6 and 470.5 mIU mL-1) at months 7 and 12 (P < 0.05). No safety concerns associated with vaccination were noted. Three-dose intramuscular immunization with hepatitis B vaccines showed good immunogenicity among the drug users.
authors.affiliation: a School of Public Health, Shanxi Medical University , Taiyuan, Shanxi , China.
authors.forename: Yongliang
authors.initials: Y
authors.lastname: Feng
authors.affiliation: a School of Public Health, Shanxi Medical University , Taiyuan, Shanxi , China.
authors.forename: Jing
authors.initials: J
authors.lastname: Shi
authors.affiliation: a School of Public Health, Shanxi Medical University , Taiyuan, Shanxi , China.
authors.forename: Linying
authors.initials: L
authors.lastname: Gao
authors.affiliation: a School of Public Health, Shanxi Medical University , Taiyuan, Shanxi , China.
authors.forename: Tian
authors.initials: T
authors.lastname: Yao
authors.affiliation: a School of Public Health, Shanxi Medical University , Taiyuan, Shanxi , China.
authors.forename: Dan
authors.initials: D
authors.lastname: Feng
authors.affiliation: b Yongji Center for Disease Control and Prevention , Yongji, Shanxi , China.
authors.forename: Dan
authors.initials: D
authors.lastname: Luo
authors.affiliation: b Yongji Center for Disease Control and Prevention , Yongji, Shanxi , China.
authors.forename: Zhansheng
authors.initials: Z
authors.lastname: Li
authors.affiliation: c Yale School of Medicine , New Haven , CT , USA.
authors.forename: Yawei
authors.initials: Y
authors.lastname: Zhang
authors.affiliation: d Chinese Center for Disease Control and Prevention , Beijing , China.
authors.forename: Fuzhen
authors.initials: F
authors.lastname: Wang
authors.affiliation: d Chinese Center for Disease Control and Prevention , Beijing , China.
authors.forename: Fuqiang
authors.initials: F
authors.lastname: Cui
authors.affiliation: d Chinese Center for Disease Control and Prevention , Beijing , China.
authors.forename: Li
authors.initials: L
authors.lastname: Li
authors.affiliation: d Chinese Center for Disease Control and Prevention , Beijing , China.
authors.forename: Xiaofeng
authors.initials: X
authors.lastname: Liang
authors.affiliation: a School of Public Health, Shanxi Medical University , Taiyuan, Shanxi , China.
authors.forename: Suping
authors.initials: S
authors.lastname: Wang
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002681:China; D055030:Drug Users; D005260:Female; D006509:Hepatitis B / Q000517:prevention & control*; D006510:Hepatitis B Antibodies / Q000097:blood*; D017325:Hepatitis B Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D000069078:Seroconversion; D019966:Substance-Related Disorders / Q000150:complications*; D055815:Young Adult
chemical_list: D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines
keywords: Hepatitis B; drug abuse; immunogenicity; randomized controlled trial; vaccination