Dose of Hepatitis B Vaccines in Non/Low-response Populations

NCT ID: NCT01564134

Last Updated: 2013-07-10

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

537 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-06-30

Brief Summary

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An interventional study will be performed in subjects aged 1-65 years old to evaluate effects of different doses of hepatitis B vaccines in low or non-response population.

Detailed Description

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A randomized clinical study will be conducted to evaluate effects of different doses of hepatitis B vaccines in low or non-response population in China. 650 low or non-response subjects after hepatitis B vaccination will be enrolled under the premise of informed consent. 200 subjects aged 1-17 years will be divided into 3 groups and 450 subjects aged 18-65years will be divided into 4 groups. Group 1/2/3 will receive 3 doses of vaccine on day 0,30 and 180, with 5ug/10ug/20ug HBs-Ag respectively. Group 4 will receive 1 dose of vaccine with 60ug HBs-Ag, low or nonresponse subjects of which will receive the second dose by an interval of at least 28 days. All vaccinations will be done by specific study personnel, who do not take part in the assessment of safety or immunogenicity. Adverse events will be recorded after vaccination and blood samples were collected at day 30 after each vaccination for antibody detection.

The clinical program approved by the ethics committee will be performed by the researchers independently. Inspectors designated by the sponsor will take meticulous on-site audits to ensure the safety specifications during the whole process of research.

Conditions

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Vaccination; Complications, Reaction, Serum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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HepB 5ug

receive the vaccine with 5ug HBsAg

Group Type EXPERIMENTAL

hepatitis B vaccine

Intervention Type BIOLOGICAL

hepatitis B vaccine with 5ug,10ug,20ug,60ug HBsAg

HepB 10ug

receive the vaccine with 10ug HBsAg

Group Type EXPERIMENTAL

hepatitis B vaccine

Intervention Type BIOLOGICAL

hepatitis B vaccine with 5ug,10ug,20ug,60ug HBsAg

HepB 20ug

receive the vaccine with 20ug HBsAg

Group Type EXPERIMENTAL

hepatitis B vaccine

Intervention Type BIOLOGICAL

hepatitis B vaccine with 5ug,10ug,20ug,60ug HBsAg

HepB 60ug

receive the vaccine with 60ug HBsAg

Group Type EXPERIMENTAL

hepatitis B vaccine

Intervention Type BIOLOGICAL

hepatitis B vaccine with 5ug,10ug,20ug,60ug HBsAg

Interventions

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hepatitis B vaccine

hepatitis B vaccine with 5ug,10ug,20ug,60ug HBsAg

Intervention Type BIOLOGICAL

Other Intervention Names

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HepB 10ug: Hansenula Polymorpha Yeast HepB 60ug: Saccharomyces cerevisiae

Eligibility Criteria

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Inclusion Criteria

* aged 1-65 years old
* male or non-pregnant female volunteers
* provide written informed consents before joining the trial
* clinically healthy as determined by: medical history inquiring and physical examination
* negative for HBsAg,HBsAb,HBcAb,HBeAg,HBeAb within the past 1 year

Exclusion Criteria

* No history of hepatitis B vaccine
* receipt of immunoglobulin within the past 1 month
* allergic to any ingredient of vaccine
* history of serious side effects, such as allergies, hives, breathing difficulties, angioedema or abdominal pain
* severe acute and chronic diseases
* autoimmune disease or immune deficiency
* axillary temperature \> 37.0 ℃ over the time of vaccination
Minimum Eligible Age

1 Year

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing Municipal Science & Technology Commission

OTHER

Sponsor Role collaborator

Wu Jiang

OTHER_GOV

Sponsor Role lead

Responsible Party

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Wu Jiang

Department of Immunization & Prevention

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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jiang wu, Bachelor

Role: PRINCIPAL_INVESTIGATOR

Beijing Centers for Disease Control and Prevention

Locations

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Xicheng Centers For Disease Prevention & Control

Xicheng District, Beijing Municipality, China

Site Status

Chifeng Centers For Disease Prevention & Control

Chifeng, Inner Mongolia, China

Site Status

Countries

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China

Other Identifiers

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BJCDCWJ201102

Identifier Type: -

Identifier Source: org_study_id

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