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Covid-19 Vaccination in Adolescents and Children (COVAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04800133
Recruitment Status : Active, not recruiting
First Posted : March 16, 2021
Last Update Posted : July 19, 2022
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong

Study Description
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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.


Condition or disease Intervention/treatment Phase
Covid19 Biological: Tozinameran Biological: CoronaVac Biological: CoronaVac, intradermal Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1018 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
Estimated Primary Completion Date : March 31, 2025
Estimated Study Completion Date : March 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: BNT162b2 (adult/adolescent)
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
 Biological: Tozinameran
mRNA vaccine developed by BioNTech against COVID-19
Other Name: BNT162b2
Experimental: CoronaVac (intramuscular)
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
 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 3 doses, or 4 for immunocompromised patients; or 1/2 dose for patients with prior COVID-19
 Biological: CoronaVac, intradermal
Inactivated virus vaccine developed by SinoVac against COVID-19, intradermal
Experimental: BNT162b2 (paediatric)
BNT162b2, tozinameran by Fosun/BioNTech Intramuscular injection (for immunocompromised patients only) 10ug/0.1ml per dose 4 doses for immunocompromised patients
 Biological: Tozinameran
mRNA vaccine developed by BioNTech against COVID-19
Other Name: BNT162b2


Outcome Measures
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Primary Outcome Measures :
  1. Adverse reactions [ Time Frame: 7 days post-doses 1, 2 and 3 (and 4) ]
    Percentage of occurrence, types, duration and severity of adverse reactions occurring within 7 days

  2. Binding antibody response [ Time Frame: 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

  3. Neutralizing antibody response [ Time Frame: 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

  4. T cell response [ Time Frame: 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


Secondary Outcome Measures :
  1. Vaccine breakthrough [ Time Frame: 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

  2. Adverse events [ Time Frame: 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

  3. Binding anti-N antibody response [ Time Frame: 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   0 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04800133


Locations
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China, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong, China
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Yu Lung Lau, MD The University of Hong Kong
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT04800133    
Other Study ID Numbers: COVAC01
First Posted: March 16, 2021    Key Record Dates
Last Update Posted: July 19, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases