Covid-19 Vaccination in Adolescents and Children

Covid19 Clinical Trial

— COVAC  

Official title:

To Compare the Reactogenicity and Immunogenicity of Recommended COVID-19 Vaccines in Young Adolescents and Children in Hong Kong

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04800133
• Other study ID #: COVAC01
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 8, 2021
• Est. completion date: March 31, 2025

Study information

• Verified date: December 2023
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1018
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Years to 100 Years

Eligibility

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)

Exclusion Criteria:

1. reported pregnancy or breastfeeding

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Biological:
• Tozinameran
mRNA vaccine developed by BioNTech against COVID-19
• CoronaVac
Inactivated virus vaccine developed by SinoVac against COVID-19, intramuscular
• CoronaVac, intradermal
Inactivated virus vaccine developed by SinoVac against COVID-19, intradermal

Locations

Country	Name	City	State
China	Queen Mary Hospital	Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse reactions	Percentage of occurrence, types, duration and severity of adverse reactions occurring within 7 days	7 days post-doses 1, 2 and 3 (and 4)
Primary	Binding antibody response	Geometric mean levels of SARS-CoV2 S and S-RBD-specific binding antibody and related markers as determined by Enzyme-linked Immunosorbent Assay	1 month post-dose 1, and 1, 6, 18, and 36 months post-dose 3 (and 2 weeks after dose 4)
Primary	Neutralizing antibody response	Geometric mean levels and geometric mean fold rise of SARS-CoV2 neutralizing antibodies as determined by plaque reduction neutralization assay and surrogate assays	1 month post-dose 1, and 1, 6, 18, and 36 months post-dose 3 (and 2 weeks after dose 4)
Primary	T cell response	Geometric mean percentage of CD4 and CD8 T cells specific to SARS-CoV2 S (and N and M) protein	1 month post-dose 1, and 1, 6, 18, and 36 months post-dose 3 (and 2 weeks after dose 4)
Secondary	Vaccine breakthrough	Incidence of COVID-19 in participants throughout study period as self-reported or as determined by Luciferase Immunoprecipitation Systems assay/ELISA	Throughout the study period, until 36 months post-dose 3/4
Secondary	Adverse events	Percentage of occurrence, types, duration and severity of adverse events and severe adverse events throughout study period	Throughout the study period, until 36 months post-dose 3/4
Secondary	Binding anti-N antibody response	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	1 month post-dose 1, and 1, 6, 18, and 36 months post-dose 3 (and 2 weeks after dose 4)