Hepatitis B Booster Study in Adolescence

NCT02169674 | Completed Phase 4 Results

• 1 other identifier: H13-00049
• Study Type: interventional
• Target: 359
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis B

Keywords

Hepatitis B; Vaccine; Immunogenicity

Outcome Measures

Primary Outcomes (2)

• Serum Anti-HBs Concentration 12 IU/L or Greater

  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.

  10 or more years after infant HB immunization

• Recollection of Anti-HBs Titer >12 IU/L After 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.

  28 days after HB booster

Other Outcomes (3)

• Geometric Mean Concentration of Anti-HBs

  Before and after booster immunization

• Anti-HBc (Hepatitis B Core Antigen) Antibody

  Baseline sample

• HBs Antigenemia

  Baseline

Study Arms (2)

10-11 Year-olds

ACTIVE COMPARATOR

Recombinant hepatitis B virus vaccine (EngerixB, GlaxoSmithKline Vaccines)

Biological: EngerixB, GlaxoSmithKline Vaccines

15-16 Year-olds

ACTIVE COMPARATOR

Recombinant hepatitis B virus vaccine (EngerixB, GlaxoSmithKline Vaccines)

Biological: EngerixB, GlaxoSmithKline Vaccines

Interventions

EngerixB, GlaxoSmithKline Vaccines BIOLOGICAL

10-11 Year-olds; 15-16 Year-olds

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Immunization Research Network: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Vaccine Evaluation Center (University of BC at Children's Hospital)

Vancouver, British Columbia, V5Z 4H4, Canada

Location

Related Publications (1)

• Pinto M, Dawar M, Krajden M, Naus M, Scheifele DW. Will Infant Hepatitis B Vaccination Protect Into Adulthood?: Extended Canadian Experience After a 2-, 4- and 6-month Immunization Schedule. Pediatr Infect Dis J. 2017 Jun;36(6):609-615. doi: 10.1097/INF.0000000000001543.

  PMID: 28134742 DERIVED

Related Links

• click here for information on the trial

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Director of Vaccine Evaluation Center
• Organization: Vaccine Evaluation Center

604-845-2422

Study Officials

• David Scheifele, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 11, 2014
• First Posted: June 23, 2014
• Study Start: September 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: May 1, 2016
• Last Updated: March 21, 2019
• Results First Posted: March 21, 2019

Record last verified: 2018-12

Locations

CA (1)