COVAC: Covid-19 Vaccination in Adolescents and Children

Sponsor
The University of Hong Kong (Other)
Overall Status
Recruiting
CT.gov ID
NCT04800133
Collaborator
(none)
1,000
Enrollment
1
Location
3
Arms
46.8
Anticipated Duration (Months)
21.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Objectives To assess the reactogenicity, measure the adaptive immune responses and track the long-term immune memory in 3-years-old or above 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 between 3-17 years old and one or both healthy parents and unrelated adults to receive one of COVID-19 vaccines by intramuscular injection (and intradermal injection for CoronaVac)

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.

Data analysis Comparison of rates of each type of adverse effects, immune responses at each timepoint across the vaccines and age groups by ANOVA and multivariate longitudinal statistical models, decay of immune response modelled by regression analysis.

Condition or DiseaseIntervention/TreatmentPhase
  • Biological: Tozinameran
  • Biological: CoronaVac
  • Biological: CoronaVac, intradermal
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1000 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
To Compare the Reactogenicity and Immunogenicity of Recommended COVID-19 Vaccines in Young Adolescents and Children in Hong Kong
Actual Study Start Date :
May 8, 2021
Anticipated Primary Completion Date :
Mar 31, 2025
Anticipated Study Completion Date :
Mar 31, 2025

Arms and Interventions

ArmIntervention/Treatment
Experimental: BNT162b2

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 2 doses given 21 days apart; or 3 doses for immunocompromised patients; or 1 dose for patients with prior COVID-19

Biological: Tozinameran
mRNA vaccine developed by BioNTech against COVID-19
Other Names:
  • BNT162b2
  • Experimental: CoronaVac (intramuscular)

    CoronaVac by SinoVac Intramuscular injection 3ug/0.5ml per dose 2 doses given 28 days apart; with 3rd dose optional; or 1 dose for patients with prior COVID-19

    Biological: CoronaVac
    Inactivated virus vaccine developed by SinoVac against COVID-19, intramuscular

    Experimental: CoronaVac (intradermal)

    CoronaVac by SinoVac Intradermal injection 3ug/0.5ml per dose 2 doses given 28 days apart; with 3rd dose optional; or 1 dose for patients with prior COVID-19

    Biological: CoronaVac, intradermal
    Inactivated virus vaccine developed by SinoVac against COVID-19, intradermal

    Outcome Measures

    Primary Outcome Measures

    1. Adverse reactions/events [7 days post-doses 1 and 2 (and 3)]

      Percentage of occurence, types, duration and severity of adverse events occurring within 7 days post-doses 1 and 2 (and 3)

    2. Binding antibody response on ELISA [1 month post-dose 1, and 1, 6, 18, and 36 months post-dose 2 (and 2 weeks after dose 3)]

      Geometric mean concentration of SARS-CoV2 S-specific binding antibody as determined by Enzyme-linked Immunosorbent Assay at 1 month post-dose 1, and 1, 6, 18, and 36 months post-dose 2 (and 2 weeks after dose 3)

    3. Neutralizing antibody response on PRNA [1 month post-dose 1, and 1, 6, 18, and 36 months post-dose 2 (and 2 weeks after dose 3)]

      Geometric mean titre and geometric mean fold rise of SARS-CoV2 neutralizing antibodies as determined by plaque reduction neutralization assay at 1 month post-dose 1, and 1, 6, 18, and 36 months post-dose 2 (and 2 weeks after dose 3)

    4. T cell response on flow cytometry [1 month post-dose 1, and 1, 6, 18, and 36 months post-dose 2 (and 2 weeks after dose 3)]

      Geometric mean percentage of CD4 and CD8 T cells specific to SARS-CoV2 S protein peptide pool at 1 month post-dose 1, and 1, 6, 18, and 36 months post-dose 2 (and 2 weeks after dose 3)

    Secondary Outcome Measures

    1. Vaccine breakthrough [Throughout the study period, until 36 months post-dose 2]

      Incidence of COVID-19 in participants throughout study period as self-reported or as determined by Luciferase Immunoprecipitation Systems assay

    2. Adverse events [Throughout the study period, until 36 months post-dose 2]

      Percentage of occurrence, types, duration and severity of adverse events and severe adverse events throughout study period

    3. Binding anti-N antibody response on ELISA [1 month post-dose 1, and 1, 6, 18, and 36 months post-dose 2 (and 2 weeks after dose 3)]

      Geometric mean titre 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 at 1 month post-dose 1, and 1, 6, 18, and 36 months post-dose 2 (and 2 weeks after dose 3)

    4. Anti-N and anti-M T cell response on flow cytometry [1 month post-dose 1, and 1, 6, 18, and 36 months post-dose 2 (and 2 weeks after dose 3)]

      Geometric mean percentage of CD4 and CD8 T cells specific to SARS-CoV2 M and N protein peptide pools in Arm C participants receiving CoronaVac at 1 month post-dose 1, and 1, 6, 18, and 36 months post-dose 2 (and 2 weeks after dose 3)

    5. Th2 cell response on flow cytometry [1 month post-dose 1, and 1, 6, 18, and 36 months post-dose 2 (and 2 weeks after dose 3)]

      Geometric mean percentage of Th2 cells specific to SARS-CoV2 peptide pools at 1 month post-dose 1, and 1, 6, 18, and 36 months post-dose 2 (and 2 weeks after dose 3)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. informed consent from the parents or a legally acceptable representative for an underage participant

    2. for students, aged 3 years or above

    3. biological parents of students enrolled in the trial or unrelated healthy adults

    4. ability to adhere to the follow-up schedules

    5. willingness to report reactogenicity daily for 7 days post dose 1 and 2 (and 3) proactively

    6. willingness to receive that vaccine available for that particular recruitment period (as student-parent pair, if applicable)

    7. good past health, including pre-existing clinically stable disease, such as paediatric or immune disorders

    8. prior COVID-19 (for COVID-19 survivor subgroup)

    Exclusion Criteria:
    1. reported pregnancy or breastfeeding

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Queen Mary HospitalHong KongHong KongChina

    Sponsors and Collaborators

    • The University of Hong Kong

    Investigators

    • Principal Investigator: Yu Lung Lau, MD, The University of Hong Kong

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The University of Hong Kong
    ClinicalTrials.gov Identifier:
    NCT04800133
    Other Study ID Numbers:
    • COVAC01
    First Posted:
    Mar 16, 2021
    Last Update Posted:
    Nov 18, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 18, 2021