Safety, humoral and cellular immunogenicity after coronavirus disease-19 (COVID-19) vaccination (BNT162b2) in 12 to 18 year-old children after liver transplantatio

Phase 3

Recruiting

• Conditions: Immunization to prevent COVID-19 infection; COVID-19, vaccination, BNT162b2, adolescent, liver transplant, immunogenicity, safety

• Registration Number: TCTR20210830002
• Lead Sponsor: Chulalongkorn university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-30
• Study Completion: 2021-12-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Children aged 12-18 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

Unstable condition, no willing to participate in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
safety At day 0-7 after dose 1 and 2 adverse events,IgG to receptor binding site At the beginning of the study, day 21, day 35 and day 51 BAU/mL,IgG to nucleocapsid antigen At the beginning, day 21, day 35 and day 51 %,neutralizing antibody At the beginning, day 21, day 35 and day 51 %,IFN-gamma At the beginning, day 21, day 35 and day 51 SFU/10 million PBMCs

Secondary Outcome Measures

Name	Time	Method
Factor related immune response At the end of the study factors