Clinical trial NCT05175989: SARS-CoV-2 Antibody Response in Children Aged 5-11 Years Following Vaccination Against COVID-19
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19 Vaccine
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 150
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children aged 5-11 years eligible for BNT162b2 vaccine

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.

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.

Eligibility 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)

Primary outcomes:
measure: 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
timeFrame: Day 56 (day 43 to 70) (28 days +/- 14 days after second injection)
Secondary outcomes:
measure: local or systemic reactogenicity events after vaccination with the BNT162b2 COVID-19 vaccine in children aged 5-11 years
timeFrame: Up to Day 56 (day 43 to 70) (28 days +/- 14 days after second injection)
measure: 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
timeFrame: Day 84 (71-98), day 112 (99-126), day 140 (127-154), day 168 (155-182), day 196 (183-197)].
measure: Seroresponse rate of vaccine recipients (greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 serum antibody levels
timeFrame: Day 56 (day 43 to 70) (28 days +/- 14 days after second injection)
measure: Number of participants with medically-attended AEs (MAAEs)
timeFrame: Up to Day 56 ((day 43 to 70) (28 days +/- 14 days after second injection)
measure: Number of participants with serious adverse events (SAEs)
timeFrame: Up to Day 56 ((day 43 to 70) (28 days +/- 14 days after second injection)
measure: Number of Participants with Adverse Events of Special Interest (AESIs), Including Multisystem Inflammatory Syndrome in Children (MIS-C)
timeFrame: Up to Day 56 (day 43 to 70) (28 days +/- 14 days after second injection)
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Schneider Children's Medical Center
Study officials:
References: