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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
537

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wu Jiang

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Beijing Municipal Science & Technology Commission

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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