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

Real-world SARS-CoV-2 Antibody Response in Children Aged 5-11 Years Following BNT162b2 mRNA Vaccination Against COVID-19: a Prospective Cohort Study

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.

Study Overview

• Status: Recruiting
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• Israel
  • Petach Tikva, Israel
    • Recruiting
    • Schneider Children's Medical Center
    • Contact: Liat Ashkenazi- Hoffnung, MD; Phone Number: 972-3-925-3770; Email: liat.ashkenazi@clalit.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 11 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children aged 5-11 years eligible for BNT162b2 vaccine

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	SARS-CoV-2 serum antibody levels	Day 56 (day 43 to 70) (28 days +/- 14 days after second injection)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
local or systemic reactogenicity events after vaccination with the BNT162b2 COVID-19 vaccine in children aged 5-11 years	Description of side effects	Up to Day 56 (day 43 to 70) (28 days +/- 14 days after second injection)
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	long-term immune response	Day 84 (71-98), day 112 (99-126), day 140 (127-154), day 168 (155-182), day 196 (183-197)].
Seroresponse rate of vaccine recipients (greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 serum antibody levels	Seroresponse rate	Day 56 (day 43 to 70) (28 days +/- 14 days after second injection)
Number of participants with medically-attended AEs (MAAEs)	medically-attended AEs	Up to Day 56 ((day 43 to 70) (28 days +/- 14 days after second injection)
Number of participants with serious adverse events (SAEs)	erious adverse events (SAEs)	Up to Day 56 ((day 43 to 70) (28 days +/- 14 days after second injection)
Number of Participants with Adverse Events of Special Interest (AESIs), Including Multisystem Inflammatory Syndrome in Children (MIS-C)	Adverse Events of Special Interest (AESIs)	Up to Day 56 (day 43 to 70) (28 days +/- 14 days after second injection)

Collaborators and Investigators

• Sponsor: Rabin Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: December 30, 2021
• First Submitted That Met QC Criteria: December 30, 2021
• First Posted (Actual): January 4, 2022

Study Record Updates

• Last Update Posted (Actual): January 28, 2022
• Last Update Submitted That Met QC Criteria: January 24, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 0810-21-RMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No