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Safety and Humoral and Cellular Immunogenicity of the BNT162b2 SARS-CoV-2 Vaccine in Liver-Transplanted Adolescents Compared to Healthy Adolescents

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210830002
Enrollment
44
Registered
2021-08-30
Start date
2021-09-07
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immunization to prevent COVID-19 infection COVID-19, vaccination, BNT162b2, adolescent, liver transplant, immunogenicity, safety

Interventions

BNT162b2 vaccine*2,BNT162b2 vaccine*2
Active Comparator Drug,Active Comparator Drug
Immunocompromised children,Healthy volunteer

Sponsors

Chulalongkorn university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 18 Years

Inclusion criteria

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

Exclusion criteria: Unstable condition, no willing to participate in the study

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Factor related immune response At the end of the study factors

Countries

Thailand

Contacts

Public ContactPalittiya Sintusek

Chulalongkorn University

piyaporn.noonun@gmail.com0899223408

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026