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Sustaining Protection Against Hepatitis B From Infancy to Adulthood: Assessing the Case for a Booster Dose in Adolescence
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.
Details
| Lead sponsor | University of British Columbia |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 359 |
| Start date | 2014-09 |
| Completion | 2016-05 |
Conditions
- Hepatitis B
Interventions
- EngerixB, GlaxoSmithKline Vaccines
Primary outcomes
- Serum Anti-HBs Concentration 12 IU/L or Greater — 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. - Recollection of Anti-HBs Titer >12 IU/L After Booster — 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.
Countries
Canada