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Trial record 1 of 1 for:    NCT04800133
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Covid-19 Vaccination in Adolescents (COVA)

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ClinicalTrials.gov Identifier: NCT04800133
Recruitment Status : Recruiting
First Posted : March 16, 2021
Last Update Posted : July 13, 2021
Sponsor:
Information provided by (Responsible Party):
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 11-years-old or above adolescents and adults such as their parents 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 their respective parents, and between the children and their parents.

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

Design and subjects A single-site, comparative nonrandomised clinical trial for 300 healthy individuals or patients between 11-17 years old and one or both healthy parents and unrelated adults to receive one of COVID-19 vaccines.

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.

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 disease Intervention/treatment Phase
Covid19 Biological: Tozinameran Biological: CoronaVac Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 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 in Hong Kong
Actual Study Start Date : May 8, 2021
Estimated Primary Completion Date : March 31, 2025
Estimated Study Completion Date : March 31, 2025

Arm Intervention/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 Name: BNT162b2

Experimental: CoronaVac
CoronaVac by SinoVac Intramuscular injection (or intradermal for immunocompromised patients) 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




Primary Outcome Measures :
  1. Adverse reactions/events [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   11 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. for students, aged 11 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
  2. history of severe neurological conditions, e.g. transverse myelitis, Guillain-Barre Syndrome (GBS), demyelinating diseases

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


Contacts
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Contact: Sau Man Chan, MNurs +85222554635 chansm13@hku.hk

Locations
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China, Hong Kong
Queen Mary Hospital Recruiting
Hong Kong, Hong Kong, China
Contact: Yu-lung LAU, MD    852-28553838 ext 4481    lauylung@hku.hk   
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Yu Lung Lau, MD The University of Hong Kong
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Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT04800133    
Other Study ID Numbers: COVA01
First Posted: March 16, 2021    Key Record Dates
Last Update Posted: July 13, 2021
Last Verified: July 2021
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