Covid-19 Vaccination in Adolescents and Children (COVAC)

  • STATUS
    Recruiting
  • End date
    Mar 31, 2025
  • participants needed
    1000
  • sponsor
    The University of Hong Kong
Updated on 25 April 2022
Accepts healthy volunteers

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.

Details
Condition Covid19
Treatment CoronaVac, Tozinameran, Oxford-AstraZeneca COVID-19 vaccine, CoronaVac, intradermal
Clinical Study IdentifierNCT04800133
SponsorThe University of Hong Kong
Last Modified on25 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

reported pregnancy or breastfeeding
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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