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Hepatitis B Booster Study in Adolescence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02169674
Recruitment Status : Completed
First Posted : June 23, 2014
Results First Posted : March 21, 2019
Last Update Posted : March 21, 2019
Sponsor:
Collaborators:
Canadian Immunization Research Network
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
David Scheifele, University of British Columbia

Brief Summary:
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 or disease Intervention/treatment Phase
Hepatitis B Biological: EngerixB, GlaxoSmithKline Vaccines Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 359 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A prospective, single-center, parallel group study of residual HBV seroprotection rates and the capacity of seronegative individuals to respond to a challenge dose of HBV vaccine.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Sustaining Protection Against Hepatitis B From Infancy to Adulthood: Assessing the Case for a Booster Dose in Adolescence
Study Start Date : September 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 10-11 Year-olds
Recombinant hepatitis B virus vaccine (EngerixB, GlaxoSmithKline Vaccines)
Biological: EngerixB, GlaxoSmithKline Vaccines
Active Comparator: 15-16 Year-olds
Recombinant hepatitis B virus vaccine (EngerixB, GlaxoSmithKline Vaccines)
Biological: EngerixB, GlaxoSmithKline Vaccines



Primary Outcome Measures :
  1. Serum Anti-HBs Concentration 12 IU/L or Greater [ Time Frame: 10 or more years after infant HB immunization ]
    The primary outcome measure is the number of participants who have residual HB immunity 10 or 15 years after infant HB immunization, defined by a persistent anti-HBs titer >12 IU/L.

  2. Recollection of Anti-HBs Titer >12 IU/L After Booster [ Time Frame: 28 days after HB booster ]
    The primary outcome measure is the number of participants who have capacity to recall anti-HBs titer >12 IU/L after HB booster vaccination.


Other Outcome Measures:
  1. Geometric Mean Concentration of Anti-HBs [ Time Frame: Before and after booster immunization ]
    The geometric mean concentration of anti-HBs antibodies before and after booster vaccination, in both age groups

  2. Anti-HBc (Hepatitis B Core Antigen) Antibody [ Time Frame: Baseline sample ]
    The number of baseline serum samples that contain anti-HBc antibodies, as a function of time since immunization

  3. HBs Antigenemia [ Time Frame: Baseline ]
    The number of baseline serum samples that contain HBs antigen, as a function of time since immunization.



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Ages Eligible for Study:   10 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 on the regular schedule with hepatitis B vaccine at approximately 2, 4, 6 months of age, based on an available immunization record.

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).
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02169674


Locations
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Canada, British Columbia
Vaccine Evaluation Center (University of BC at Children's Hospital)
Vancouver, British Columbia, Canada, V5Z 4H4
Sponsors and Collaborators
University of British Columbia
Canadian Immunization Research Network
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: David Scheifele, MD University of British Columbia
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: David Scheifele, Clinical Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT02169674    
Other Study ID Numbers: H13-00049
First Posted: June 23, 2014    Key Record Dates
Results First Posted: March 21, 2019
Last Update Posted: March 21, 2019
Last Verified: December 2018
Keywords provided by David Scheifele, University of British Columbia:
Hepatitis B
Vaccine
Immunogenicity
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections