Trial record 57 of 444 for:    hepatitis b | Open Studies

Hepatitis B Booster Study in Adolescence

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by University of British Columbia
Sponsor:
Collaborators:
Canadian Immunization Research Network
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT02169674
First received: June 11, 2014
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

This study looks at protection in 10-11 and 15-16 year olds, immunized as infants with Hepatitis B (HB) vaccine to see if they still have residual protection against Hepatitis B disease. Adolescents will be invited to have a blood test and those without a minimal level of protection (antibody titer) will be offered a "test" vaccination to see if they still have capacity to recall an immune response. About one month later they will get another blood test to see if a booster response occurred. A few participants will have lost protection (no booster response) and will be offered a second HB vaccination to restore protection. Results of this study could influence the way in which children in British Columbia (BC) are immunized against HB disease.


Condition
Hepatitis B

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sustaining Protection Against Hepatitis B From Infancy to Adulthood: Assessing the Case for a Booster Dose in Adolescence

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Serum anti-HBs concentration 10 IU/L or greater [ Time Frame: 10 or more years after infant HB immunization ] [ Designated as safety issue: No ]
    The primary outcome measure is the proportion of participants who have residual HB immunity 10 or 15 years after infant HB immunization, defined by a persistent anti-HBs titer >10 IU/L.

  • Recollection of anti-HBs titer >10 IU/L after booster [ Time Frame: 28 days after HB booster ] [ Designated as safety issue: No ]
    The primary outcome measure is the proportion of participants who have capacity to recall anti-HBs titer >10 IU/L after HB booster vaccination.


Other Outcome Measures:
  • Geometric mean concentration of anti-HBs [ Time Frame: Before and after booster immunization ] [ Designated as safety issue: No ]
    The geometric mean concentration of anti-HBs antibodies before and after booster vaccination, in both age groups

  • Anti-HBc (Hepatitis B core antigen) antibody [ Time Frame: Baseline sample ] [ Designated as safety issue: No ]
    The proportion of baseline serum samples that contain anti-HBc antibodies, as a function of time since immunization

  • HBs antigenemia [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The proportion of baseline serum samples that contain HBs antigen, as a function of time since immunization.


Estimated Enrollment: 360
Study Start Date: September 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   10 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Community based, healthy children who have received 3 doses of Hepatitis B vaccine as infants in British Columbia

Criteria

Inclusion Criteria:

  • Age 10-11 or 15-16 years
  • Written informed assent provided by 10-11 year old participants and consent by their parent or legal guardian OR written informed consent provided by a 15-16 year old participant.
  • Subjects whom the investigator believes can and will comply with the requirements of the protocol.
  • General good health
  • Immunized in BC with hepatitis B vaccine at approximately 2, 4, 6 months of age, based on an available immunization record. Dose 3 of the series must have been administered no later than 9 months (39 weeks) of age.

Exclusion Criteria:

  • Hepatitis B vaccination regimen for infants born to a mother with hepatitis B infection (e.g. doses at birth and ages 1 and 6 months, with or without HB immune globulin at birth).
  • Hepatitis B vaccination in infancy with the third dose administered after 39 weeks of age or with an interval after the second dose ≥4 months (16 weeks).
  • Receipt of any additional dose(s) of hepatitis B vaccine beyond infancy.
  • Systemic hypersensitivity to hepatitis B vaccine or severe reaction to any previous dose of hepatitis B vaccine.
  • Receipt of blood or blood product within 3 months prior to Visit 1.
  • Immune compromise resulting from disease or immunosuppressive systemic medication use within 3 months prior to Visit 1.
  • Chronic health condition requiring ongoing medical supervision e.g. cystic fibrosis.
  • Incapacity to provide fully informed assent, resulting from cognitive impairment.
  • Inadequate participant or parental (when the parent will provide consent) fluency in English to provide fully informed consent.
  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: NCT02169674

Contacts
Contact: Ivor Chee, BScN 604 875-2187 ichee@cfri.ca
Contact: Cecilia Jankowski 604 875-2422 cjankowski@cfri.ca

Locations
Canada, British Columbia
Vaccine Evaluation Center (University of BC at Children's Hospital) Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 4H4
Principal Investigator: David Scheifele, MD         
Sponsors and Collaborators
University of British Columbia
Canadian Immunization Research Network
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: David Scheifele, MD University of British Columbia
  More Information

Additional Information:
No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT02169674     History of Changes
Other Study ID Numbers: H13-00049
Study First Received: June 11, 2014
Last Updated: June 18, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Hepatitis B
Vaccine
Immunogenicity

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

ClinicalTrials.gov processed this record on July 29, 2014