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

July 9, 2013 updated by: Wu Jiang

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

537

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Xicheng District, Beijing, China, 100011
        • Xicheng Centers For Disease Prevention & Control
    • Inner Mongolia
      • Chifeng, Inner Mongolia, China, 024000
        • Chifeng Centers For Disease Prevention & Control

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HepB 5ug
receive the vaccine with 5ug HBsAg
Biological: hepatitis B vaccine
hepatitis B vaccine with 5ug,10ug,20ug,60ug HBsAg
Other Names:
  • HepB 10ug: Hansenula Polymorpha Yeast
  • HepB 60ug: Saccharomyces cerevisiae
Experimental: HepB 10ug
receive the vaccine with 10ug HBsAg
Biological: hepatitis B vaccine
hepatitis B vaccine with 5ug,10ug,20ug,60ug HBsAg
Other Names:
  • HepB 10ug: Hansenula Polymorpha Yeast
  • HepB 60ug: Saccharomyces cerevisiae
Experimental: HepB 20ug
receive the vaccine with 20ug HBsAg
Biological: hepatitis B vaccine
hepatitis B vaccine with 5ug,10ug,20ug,60ug HBsAg
Other Names:
  • HepB 10ug: Hansenula Polymorpha Yeast
  • HepB 60ug: Saccharomyces cerevisiae
Experimental: HepB 60ug
receive the vaccine with 60ug HBsAg
Biological: hepatitis B vaccine
hepatitis B vaccine with 5ug,10ug,20ug,60ug HBsAg
Other Names:
  • HepB 10ug: Hansenula Polymorpha Yeast
  • HepB 60ug: Saccharomyces cerevisiae

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seroconversion rates of different doses of vaccines the levels of HBs-Ab after vaccination
Time Frame: day 30 after each vaccination
describe the levels of HBs-Ab after each vaccination and compare the percentages of adverse events in all groups
day 30 after each vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wu Jiang

Collaborators

Beijing Municipal Science & Technology Commission

Investigators

  • Principal Investigator: jiang wu, Bachelor, Beijing Centers for Disease Control and Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

March 23, 2012

First Submitted That Met QC Criteria

March 26, 2012

First Posted (Estimate)

March 27, 2012

Study Record Updates

Last Update Posted (Estimate)

July 10, 2013

Last Update Submitted That Met QC Criteria

July 9, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BJCDCWJ201102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vaccination; Complications, Reaction, Serum

Clinical Trials on hepatitis B vaccine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe