Study on New Strategies for Hepatitis B Virus Immunization

Wu Jiang1,169 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

1,169

Conditions

Vaccine Reaction

Interventions

20μg Engerix-B hepatitis B vaccineBIOLOGICAL

20μg Kangtai hepatitis B vaccineBIOLOGICAL

60μg Kangtai hepatitis B vaccineBIOLOGICAL

20μg CHO

Eligibility

Sex: ALLMin age: 25 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Huaibei District Center for Disease Control and Prevention

Huaibei, Anhui, China

Xuanhua District Center for Disease Control and Prevention

Xuanhua, Hebei, China

Outcomes

Primary Outcomes

Anti-HBs

Titers of hepatitis B virus surface antibody

Time frame: at the second month after the final injection of each arm

Data from ClinicalTrials.gov

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