NCT02959775

Immunogenicity of Hepatitis B Vaccination Among Drug Users

Immunogenicity and Safety of High-dose Hepatitis B Vaccine Among Drug Users: a Randomized, Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 480 (actual)
• Sponsor: Shanxi Medical University · Academic / Other
• Sex: Male
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Uptake, adherence, and completion of vaccination among drug users were low, and their immune function and immune response to hepatitis B vaccination were also suboptimal, indicating that the current practice of hepatitis B vaccination can't protect drug users from HBV infection. This is a randomized, open-label, blank-controlled trial, conducted among drug users with drug rehabilitation. This study will compare the immunogenicity and safety of three intramuscular 20µg and 60µg recombinant hepatitis B vaccines at months 0, 1, and 6 among drug users

Detailed description

Comparison of 2 vaccination strategy against Hepatitis B in Drug Users Intervention: Arm 1 : Receive three intramuscular injections of 60 µg recombinant hepatitis B vaccine at months 0, 1 and 6; Arm 2 : Receive three intramuscular injections of 20 µg recombinant hepatitis B vaccine at months 0, 1 and 6; Arm 3 : Receive no vaccination during the study period.

Conditions

• Hepatitis B Vaccination

Interventions

Type	Name	Description
BIOLOGICAL	60 µg dose hepatitis B vaccine	three-dose, 60 µg per dose
BIOLOGICAL	20 µg dose hepatitis B vaccine	three-dose, 20 µg per dose

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-05-01
• Completion: 2015-10-01
• First posted: 2016-11-09
• Last updated: 2022-02-18
• Results posted: 2022-02-18