Phase 4
Completed N=350
Hepatitis B Booster Study in Adolescence
Source: ClinicalTrials.gov NCT02169674 ↗Enrolled (actual)
350
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcomePrimary: Serum Anti-HBs Concentration 12 IU/L or Greater — 30; 76 Participants
◆ Published Evidence
Emerging
16citations · ~2 / year
Will Infant Hepatitis B Vaccination Protect Into Adulthood?: Extended Canadian Experience After a 2-, 4- and 6-month Immunization Schedule.
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.
Linked Publications
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Will Infant Hepatitis B Vaccination Protect Into Adulthood?: Extended Canadian Experience After a 2-, 4- and 6-month Immunization Schedule.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.