Covid-19 Vaccination in Adolescents and Children

Phase 2

Active, not recruiting

• Conditions: Covid19
• Interventions: Biological: Tozinameran; Biological: CoronaVac; Biological: CoronaVac, intradermal

• Registration Number: NCT04800133
• Lead Sponsor: The University of Hong Kong

Brief Summary

Objectives To assess the reactogenicity, measure the adaptive immune responses and track the long-term immune memory in healthy children and adults as well as pediatric patients receiving the COVID-19 vaccines-BNT162b2, CoronaVac-chosen by the Hong Kong Government; to compare the reactogenicity and immunogenicity across the vaccines used for these children and adults.

Hypothesis to be tested The safety profile and the magnitude and durability of immune responses to the COVID-19 vaccines in children are non-inferior to those in adults.

Design and subjects A single-site, comparative nonrandomised clinical trial for 450 healthy individuals or patients under 18 years old and one or both healthy parents and unrelated adults to receive one of COVID-19 vaccines by intramuscular injection (and intradermal injection)

Instruments Mobile app for subjects to record adverse effects, enzyme-linked immunosorbent assay, plaque reduction neutralization assay, luciferase immunoprecipitation system assay and flow cytometry.

Interventions BNT162b2 and CoronaVac, by intramuscular or intradermal route

Main outcome measures Types and frequencies of adverse effects within 7 days, and changes and peaks of antibody levels and antigen-specific memory T cell responses for 3 years.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-03-01
• Study First Submitted QC: 2021-03-15
• Study First Posted: 2021-03-16
• Study Start: 2021-05-08
• Status Verified: 2023-12
• Last Update Submitted: 2024-01-12
• Last Update Posted: 2024-01-16
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1018

Inclusion Criteria

1. informed consent from the parents or a legally acceptable representative for an underage participant
2. biological parents of students enrolled in the trial or unrelated healthy adults
3. ability to adhere to the follow-up schedules
4. willingness to report reactogenicity daily for 7 days post dose 1, 2 and 3 (and 4) proactively
5. willingness to receive that vaccine available for that particular recruitment period (as student-parent pair, if applicable)
6. good past health, including pre-existing clinically stable disease, such as paediatric or immune disorders
7. prior COVID-19 (for COVID-19 survivor subgroup)

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Exclusion Criteria

1. reported pregnancy or breastfeeding

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BNT162b2 (adult/adolescent)	Tozinameran	BNT162b2, tozinameran by Fosun/BioNTech Intramuscular injection (or intradermal for immunocompromised patients; or by graded challenge with history of non-severe allergy to PEG-containing drugs) 30ug/0.3ml per dose 3 doses, or 4 for immunocompromised patients; or 1/2 dose for patients with prior COVID-19
BNT162b2 (paediatric)	Tozinameran	BNT162b2, tozinameran by Fosun/BioNTech Intramuscular injection (for immunocompromised patients only) 10ug/0.1ml per dose 4 doses for immunocompromised patients
CoronaVac (intramuscular)	CoronaVac	CoronaVac by SinoVac Intramuscular injection 3ug/0.5ml per dose 3 doses, or 4 for immunocompromised patients; or 1/2 dose for patients with prior COVID-19
CoronaVac (intradermal)	CoronaVac, intradermal	CoronaVac by SinoVac Intradermal injection 3ug/0.5ml per dose 3 doses, or 4 for immunocompromised patients; or 1/2 dose for patients with prior COVID-19

Primary Outcome Measures

Name	Time	Method
Neutralizing antibody response	1 month post-dose 1, and 1, 6, 18, and 36 months post-dose 3 (and 2 weeks after dose 4)	Geometric mean levels and geometric mean fold rise of SARS-CoV2 neutralizing antibodies as determined by plaque reduction neutralization assay and surrogate assays
T cell response	1 month post-dose 1, and 1, 6, 18, and 36 months post-dose 3 (and 2 weeks after dose 4)	Geometric mean percentage of CD4 and CD8 T cells specific to SARS-CoV2 S (and N and M) protein
Adverse reactions	7 days post-doses 1, 2 and 3 (and 4)	Percentage of occurrence, types, duration and severity of adverse reactions occurring within 7 days
Binding antibody response	1 month post-dose 1, and 1, 6, 18, and 36 months post-dose 3 (and 2 weeks after dose 4)	Geometric mean levels of SARS-CoV2 S and S-RBD-specific binding antibody and related markers as determined by Enzyme-linked Immunosorbent Assay

Secondary Outcome Measures

Name	Time	Method
Vaccine breakthrough	Throughout the study period, until 36 months post-dose 3/4	Incidence of COVID-19 in participants throughout study period as self-reported or as determined by Luciferase Immunoprecipitation Systems assay/ELISA
Binding anti-N antibody response	1 month post-dose 1, and 1, 6, 18, and 36 months post-dose 3 (and 2 weeks after dose 4)	Geometric mean levels and geometric mean fold rise of SARS-CoV2 N-specific binding antibody as determined by Enzyme-linked Immunosorbent Assay in Arm C participants receiving CoronaVac
Adverse events	Throughout the study period, until 36 months post-dose 3/4	Percentage of occurrence, types, duration and severity of adverse events and severe adverse events throughout study period

Trial Locations

Locations (1)

Queen Mary Hospital; 🇨🇳 Hong Kong, Hong Kong, China