Study on New Strategies for Hepatitis B Virus Immunization

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1169 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-01

Study Completion Date

2015-12-31

Brief Summary

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To investigate the immunogenicity of HB vaccine with different series among primary immune adults aged 25-55, to assess potential alternative approaches for HB immunization.

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Detailed Description

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By comparing the immunization effect of hepatitis B vaccine with other different types of hepatitis B vaccines using seris procedure, information on the immunization effect of 60 micrograms of hepatitis B vaccine in adults was obtained, which will provide a scientific basis for the development of a rapid immunization procedure for adults with large doses of hepatitis B vaccine and for the improvement of the immunization strategy for hepatitis B in adults.

Conditions

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Vaccine Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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20μg Engerix-B with 0-1-6 intervals

Received three intramuscular injections of the 20μg Engerix-B vaccine with 0, 1, 6 month intervals

Group Type EXPERIMENTAL

20μg Engerix-B hepatitis B vaccine

Intervention Type BIOLOGICAL

20μg Kangtai with 0-1-6 intervals

Received three intramuscular injections of the 20μg Kangtai hepatitis B vaccine with 0, 1, 6 month intervals

Group Type EXPERIMENTAL

20μg Kangtai hepatitis B vaccine

Intervention Type BIOLOGICAL

60μg Kangtai with 0-2 intervals

Received two intramuscular injections of the 60μg Kangtai hepatitis B vaccine with 0, 2 month intervals

Group Type EXPERIMENTAL

60μg Kangtai hepatitis B vaccine

Intervention Type BIOLOGICAL

20μg CHO with 0-1-6 intervals

Received three intramuscular injections of the 20μg Huabei hepatitis B vaccine made by recombinant DNA techniques in CHO cell with 0, 1, 6 month intervals

Group Type PLACEBO_COMPARATOR

20μg CHO

Intervention Type BIOLOGICAL

Interventions

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20μg Engerix-B hepatitis B vaccine

Intervention Type BIOLOGICAL

20μg Kangtai hepatitis B vaccine

Intervention Type BIOLOGICAL

60μg Kangtai hepatitis B vaccine

Intervention Type BIOLOGICAL

20μg CHO

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* aged 25-55 years
* negative for HBsAg,anti-HBs, and anti-HBc without prior HBV or HAV vaccination

Exclusion Criteria

* a history of vaccine component allergies
* autoimmune diseases
* immunodeficiency
* vaccinations received within the past month
* acute illnesses within the past week
* fever (axillary temperature exceeding 38°C) within the past three days

Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes