Phase 4
N=350
Hepatitis B Booster Study in Adolescence
Hepatitis B
Bottom Line
View on ClinicalTrials.gov: NCT02169674 ↗Enrolled (actual)
350
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Serum Anti-HBs Concentration 12 IU/L or Greater — 30; 76 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- EngerixB, GlaxoSmithKline Vaccines (Biological)
- Age
- Pediatric · 10+ yrs
- Sex
- All
- Sponsor
- University of British Columbia
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Anti-HBs Concentration 12 IU/L or Greater |
30; 76 | — |
| PRIMARY Recollection of Anti-HBs Titer >12 IU/L After Booster |
102; 123 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02169674). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.