Immunization to prevent COVID-19 infection. COVID-19, vaccination, BNT162b2, children, liver transplant, immunogenicity, safety
Conditions
Interventions
BNT162b2 vaccine 0.2 mL * 2 injections
Active Comparator Drug
Liver transplanted children
Sponsors
Chulalongkorn University
Eligibility
Sex/Gender
All
Age
5 Years to 12 Years
Inclusion criteria
Inclusion criteria: Children aged 5-12 years who underwent liver transplant for more than 6 months, clinical stable condition, no history of COVID-19 infection, no history of drug or vaccine allergy.
Exclusion criteria
Exclusion criteria: Unstable condition, fever, abnormal liver function test, no willing to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety at d1-7 after dose 1 and 2 Adverse effect | — |
Secondary
| Measure | Time frame |
|---|---|
| IgG to receptor binding protein At 5 time points (day0, wk5, wk8, wk16, wk28) U/mL,IgG to nucleocapsit antigen wk 5 %,Neutralizing antibody wk8, wk28 %,IFN-gamma Day0, wk3, wk5, wk16 SFU/10 million PBMCs | — |
Countries
Thailand
Contacts
Public ContactPalittiya Sintusek
Faculty of Medicine, Chulalongkorn University
Outcome results
None listed