Immunogenicity and Reactogenicity of mRNA BNT162b2 COVID-19 Vaccine among Thai Adolescents with Chronic Diseases

Completed

• Conditions: mRNA COVID-19 vaccine in adolescence between 12-18 years of age with chronic disease; mRNA COVID-19 vaccine; adolescence; chronic disease; reactogenicity; immunogenicity

• Registration Number: TCTR20210826001
• Lead Sponsor: Pediatric Infectious Disease Society of Thailand (PIDST)

Brief Summary

Our findings show that adolescents with impaired immunity had a poor immune response after the 2-dose of BNT162b2 vaccination, and require an additional dose as recommended by the Advisory Committee on Immunization Practices. For adolescents with other chronic diseases, 2-dose of BNT162b provide high neutralizing antibody up to 3 to 6 m post vaccination. However, with the era of Omicron variants, with immune escape, a booster dose should also be considered.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-26
• Study Completion: 2021-10-01
• Results First Posted: 2022-05-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Adolescence between 12-18 years of age at the enrollment date
No history of COVID-19 vaccination
No history of COVID-19 infection

Exclusion Criteria

Acute fever with body temperature above 37.8 degree Celsius within 3 days
History of drug anaphylaxis or vaccine ingredient allergy
History of lived vaccine administration within 4 weeks

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immunogenicity 1 months after complete vaccination Anti-S-RBD antibody level and ELISpot,Reactogenicity 14 days after vaccination Diary card

Secondary Outcome Measures

Name	Time	Method
Persistent of immune response 6 months after complete vaccination Anti-S-RBD antibody level and ELISpot,Immunogenicity 6 months after complete vaccination Anti-S-RBD antibody level and ELISpot