Investigating COVID-19 Vaccine Immunity in Children in the Melbourne Infant Study of BCG for Allergy and Infection Reduction (COSI BAIR)

Murdoch Childrens Research Institute

Status and phase: Completed; Phase 4

Conditions: COVID-19; Immunization; Infection; Vaccine Reaction

Treatments: Biological: Tozinameran

Study type: Interventional

Funder types: Other

Identifiers

NCT05168709

81771

Details and patient eligibility

About

The COSI BAIR trial will involve approximately 60 children, aged 5 to 8 years old, comprising a subset of participants from the Melbourne Infant Study BCG for Allergy and Infection Reduction (MIS BAIR) randomised controlled trial. The overall aim of this trial is to investigate the specific and heterologous effects of COVID-19 vaccination on immunity in children. COSI BAIR will aim to recruit its participants from the MIS BAIR Bacillus Calmette-Guérin (BCG)-naïve group. These children will be followed up until 28 days after their final Coronavirus Disease 2019 (COVID-19) vaccination.

Venous blood samples will be collected at two study visits, at Murdoch Children's Research Institute (MCRI):

1. Day 0 - baseline (day of COVID-19 vaccination #1), and
2. Day 84 (28 days after COVID-19 vaccination #2).

Enrollment: 51 patients

Sex: All

Ages: 5 to 11 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age between five and eleven years (i.e. prior to the twelfth birthday) at the time of enrolment,

• Participant who was randomised in the MIS BAIR trial, and

  • Was randomly allocated to receive and received BCG as part of the MIS BAIR trial, OR,
  • Was randomly allocated to not receive and did not receive BCG;

• Is an individual whose parent/legally acceptable representative (LAR) consented to be contacted about future ethically approved research, during the MIS BAIR trial consent process, AND

• Has a parent/LAR capable of understanding the parent/LAR information statement and consent form (PICF) document and providing consent on the participant's behalf.

Exclusion criteria

• Has a known hypersensitivity to the active ingredient or any of the excipients in tozinameran,
• Has a prior polymerase chain reaction (PCR)-confirmed diagnosis of COVID-19 whether symptomatic or not,
• Has received a COVID-19 vaccine (approved by the TGA or otherwise) prior to trial enrolment,
• An individual and/or parent/legally acceptable representative who is unwilling or unable to give written informed consent,
• An individual and/or parent/legally acceptable representative who is unwilling or unable to consent to attend all scheduled study visits,
• An individual and/or parent/LAR who is unwilling or unable to give consent for blood samples to be taken from the trial participant at each study visit, and
• Has or has had a clinically significant medical morbidity (e.g. immunocompromised because of congenital or acquired disorders or immunosuppressive medical treatment; a bleeding disorder; a recent history of inflammatory cardiac illness within the past 6 months, e.g., myocarditis, pericarditis, endocarditis, acute rheumatic fever (with active myocardial inflammation) or acute rheumatic heart disease, or acute decompensated heart failure), and
• Has received BCG at any other time than as part of the MIS BAIR trial.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

Approved COVID-19 vaccination

Experimental group

Description:

The approved COVID-19 vaccination arm will receive the COMIRNATY™ (tozinameran - BNT162b2 \[mRNA\]) COVID-19 VACCINE. The dose, strength of the dose unit, dosing interval and dosing period of tozinameran used in this trial will be as approved by the Therapeutic Goods Administration (TGA) and recommended by the Australian Technical Advisory Group on Immunisation (ATAGI) for children aged 5 to \<12 years of age. The recommended dose of tozinameran for this age group is 10 µg (0.2 mL) and the recommended schedule is 2 doses, 8 weeks apart. Therefore two tozinameran doses of 10µg (0.2 mL) will be administered intramuscularly 8-weeks apart as part of this arm of the trial.

Treatment:

Biological: Tozinameran