Immunogenicity of Hepatitis B Vaccination Among Drug Users

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-10-31

Brief Summary

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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

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Detailed Description

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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

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Hepatitis B Vaccination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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60 µg dose hepatitis B vaccine

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

Group Type EXPERIMENTAL

60 µg dose hepatitis B vaccine

Intervention Type BIOLOGICAL

three-dose, 60 µg per dose

20 µg dose hepatitis B vaccine

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

Group Type EXPERIMENTAL

20 µg dose hepatitis B vaccine

Intervention Type BIOLOGICAL

three-dose, 20 µg per dose

Control

Receive no vaccination during the study period

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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60 µg dose hepatitis B vaccine

three-dose, 60 µg per dose

Intervention Type BIOLOGICAL

20 µg dose hepatitis B vaccine

three-dose, 20 µg per dose

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No