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SARS-CoV-2 Antibody Response in Children Aged 5-11 Years Following Vaccination Against COVID-19

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ClinicalTrials.gov Identifier: NCT05175989
Recruitment Status : Recruiting
First Posted : January 4, 2022
Last Update Posted : January 28, 2022
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center

Study Description
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Brief Summary:
There are few data on the immunogenicity of the Pfizer-Biontec BNT162b2 vaccine for the prevention of COVID-19 disease and of side effects in children aged 5-11 years. Therefore, our aim is to determine the immunogenicity and to describe the local or systemic reactogenicity events after vaccination with the BNT162b2 COVID-19 vaccine in children aged 5-11 years for a period of six and half months following the first dose of the vaccine.

Condition or disease
COVID-19 Vaccine

Detailed Description:

The Pfizer-Biontec BNT162b2 vaccine has proven efficacy and safety for the prevention of COVID-19 disease in adults and adolescents aged 12 years and older. Efficacy and safety were recently shown also for children aged 5-11 years. Side-effects are common, including some rare but important side-effects such as myocarditis. Myocarditis post Pfizer-Biontec BNT162b2 vaccination was described mostly among male adolescents and young adults. There are few data on the immunogenicity of the vaccine and of side effects in children aged 5-11 years. Therefore, our aim is to determine the immunogenicity and to describe the local or systemic reactogenicity events after vaccination with the BNT162b2 COVID-19 vaccine in children aged 5-11 years.

This is a prospective cohort study assessing the immunogenicity of the BNT162b2 COVID-19 vaccine in children. The study population will be composed of children aged 5-11 years at the Schneider Children's Medical Center, with no contraindication for COVID-19 vaccination. Upon enrollment in the study, participates will be requested to complete an enrollment questionnaire and a blood sample for baseline serological evaluation will be obtained.

The study follow-up period will be 6 and a half months from receipt of the first dose of the vaccine. The study will last 6 months from the date of the approval of the study protocol.

Blood samples for immune response evaluation will be taken at intervals of 28 days (+/- 14) until 6 and a half months from receipt of the first dose of the vaccine. Samples will be tested for antibodies to SARS-CoV-2 at the Microbiology Laboratory at the Rabin Medical Center. Symptomatic participants with any respiratory symptoms or other symptoms suggestive of COVID-19 disease will be tested for SARS-CoV-2 by RT-PCR, at laboratories certified by the Ministry of Health.

Study Design
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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real-world SARS-CoV-2 Antibody Response in Children Aged 5-11 Years Following BNT162b2 mRNA Vaccination Against COVID-19: a Prospective Cohort Study
Actual Study Start Date : January 10, 2022
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Immunogenicity of the Pfizer-Biontec BNT162b2 COVID-19 vaccine in children aged 5-11 years. Our second aim is to describe the local or systemic reactogenicity events after vaccination with the BNT162b2 COVID-19 vaccine in children [ Time Frame: Day 56 (day 43 to 70) (28 days +/- 14 days after second injection) ]
    SARS-CoV-2 serum antibody levels


Secondary Outcome Measures :
  1. local or systemic reactogenicity events after vaccination with the BNT162b2 COVID-19 vaccine in children aged 5-11 years [ Time Frame: Up to Day 56 (day 43 to 70) (28 days +/- 14 days after second injection) ]
    Description of side effects

  2. Evaluation of the long-term immune response following the BNT162b2 vaccine by SARS-CoV-2 serum antibody levels that meet or exceed the threshold of protection From COVID-19 [ Time Frame: Day 84 (71-98), day 112 (99-126), day 140 (127-154), day 168 (155-182), day 196 (183-197)]. ]
    long-term immune response

  3. Seroresponse rate of vaccine recipients (greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 serum antibody levels [ Time Frame: Day 56 (day 43 to 70) (28 days +/- 14 days after second injection) ]
    Seroresponse rate

  4. Number of participants with medically-attended AEs (MAAEs) [ Time Frame: Up to Day 56 ((day 43 to 70) (28 days +/- 14 days after second injection) ]
    medically-attended AEs

  5. Number of participants with serious adverse events (SAEs) [ Time Frame: Up to Day 56 ((day 43 to 70) (28 days +/- 14 days after second injection) ]
    erious adverse events (SAEs)

  6. Number of Participants with Adverse Events of Special Interest (AESIs), Including Multisystem Inflammatory Syndrome in Children (MIS-C) [ Time Frame: Up to Day 56 (day 43 to 70) (28 days +/- 14 days after second injection) ]
    Adverse Events of Special Interest (AESIs)


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Children aged 5-11 years eligible for BNT162b2 vaccine
Criteria

Inclusion Criteria:

Age 5-11 years

Exclusion Criteria:

Administration of COVID-19 vaccine>21 days prior to enrollment, Contraindication for COVID-19 vaccine such as, known hypersensitivity to a component of the vaccine or its excipients Congenital or acquired immunodeficiency (including recipient of systemic steroids ≥2 mg/kg or ≥20mg/day, within two weeks prior to enrollment)

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): NCT05175989


Locations
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Israel
Schneider Children's Medical Center Recruiting
Petach Tikva, Israel
Contact: Liat Ashkenazi- Hoffnung, MD    972-3-925-3770    liat.ashkenazi@clalit.org.il   
Sponsors and Collaborators
Rabin Medical Center
More Information
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Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT05175989    
Other Study ID Numbers: 0810-21-RMC
First Posted: January 4, 2022    Key Record Dates
Last Update Posted: January 28, 2022
Last Verified: January 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
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