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

This study has been completed.
Sponsor:
Collaborator:
Beijing Municipal Science & Technology Commission
Information provided by (Responsible Party):
Wu Jiang, Centers for Disease Control and Prevention, China
ClinicalTrials.gov Identifier:
NCT01564134
First received: March 23, 2012
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Vaccination; Complications, Reaction, Serum
Biological: hepatitis B vaccine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Dose of Hepatitis B Vaccines in Non/Low-response Populations

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention, China:

Primary Outcome Measures:
  • Seroconversion rates of different doses of vaccines the levels of HBs-Ab after vaccination [ Time Frame: day 30 after each vaccination ] [ Designated as safety issue: Yes ]
    describe the levels of HBs-Ab after each vaccination and compare the percentages of adverse events in all groups


Enrollment: 537
Study Start Date: August 2011
Study Completion Date: June 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   1 Year to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01564134

Locations
China, Beijing
Xicheng Centers For Disease Prevention & Control
Xicheng District, Beijing, China, 100011
China, Inner Mongolia
Chifeng Centers For Disease Prevention & Control
Chifeng, Inner Mongolia, China, 024000
Sponsors and Collaborators
Wu Jiang
Beijing Municipal Science & Technology Commission
Investigators
Principal Investigator: jiang wu, Bachelor Beijing Centers for Disease Control and Prevention
  More Information

No publications provided

Responsible Party: Wu Jiang, Department of Immunization & Prevention, Centers for Disease Control and Prevention, China
ClinicalTrials.gov Identifier: NCT01564134     History of Changes
Other Study ID Numbers: BJCDCWJ201102
Study First Received: March 23, 2012
Last Updated: July 9, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Centers for Disease Control and Prevention, China:
response vaccination

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on August 26, 2014