Immunogenicity of Hepatitis B Vaccination Among Drug Users

Shanxi Medical University

Status and phase: Completed; Phase 4

Conditions: Hepatitis B Vaccination

Treatments: Biological: 20 µg dose hepatitis B vaccine; Biological: 60 µg dose hepatitis B vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT02959775

2012ZX10002001003004002

Details and patient eligibility

About

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

Full 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.

Enrollment: 480 patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged between 18 and 70 years at the enrolment
• current illicit drug users before drug rehabilitation
• negative for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs) at enrollment
• having spent acute physiological detoxification phase

Exclusion criteria

• any intolerance or allergy to any component of the vaccine
• ongoing opportunistic infection
• liver disease
• hemopathy
• cancer
• unexplained fever in the last week before the recruiting

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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480 participants in 3 patient groups

60 µg dose hepatitis B vaccine

Experimental group

Description:

Receive three intramuscular injections of 60 µg recombinant hepatitis B vaccine at months 0, 1 and 6

Treatment:

Biological: 60 µg dose hepatitis B vaccine

20 µg dose hepatitis B vaccine

Experimental group

Description:

Receive three intramuscular injections of 20 µg recombinant hepatitis B vaccine at months 0, 1 and 6

Treatment:

Biological: 20 µg dose hepatitis B vaccine

Control

No Intervention group

Description:

Receive no vaccination during the study period