Safety and efficacy of hepatitis B vaccine, standard compare to double dose in short and long term follow-up. infection, bleeding, pain
Conditions
Interventions
Hepatitis B vaccine will be given 3 doses (0.5 ml/dose) to participant with initial antiHBs antibody is less than 100 mIU/mL,Hepatitis B vaccine will be given 3 doses (1 ml/dose) to participant with i
Hepatitis B vaccine (standard dose),Hepatitis B vaccine (double dose)
Sponsors
Chulalonkorn University
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: Participants age less than 18 years old, post liver transplantation, do not on steroid as immunosuppressants, antiHBs antibody less than 100 mIU/mL
Exclusion criteria
Exclusion criteria: Participant who has serious illness such as fever, loss follow up, on steroid as immunosuppressant therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AntiHBs antibody level after full immunization in short term follow-up 12 months after the first dose of hepatitis B vaccine and then every 3-6 months follow-up until anti-HBs less than 100 mIU/mL blood sampling,Humoral and cellular response in long term follow-up 12 months after complete 3-dose regimen and then every 3-6 months at clinic visits until anti-HBs less than 100 mIU/mL anti-HBs and specific T cells | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of hepatitis B vaccine 1 month after vaccination Adverse effect of vaccine | — |
Countries
Thailand
Contacts
Public ContactPalittiya Sintusek
Chulalonkorn University
Outcome results
None listed