Pediatric Research Observing Trends and Exposures in COVID-19 Timelines (PROTECT): Protocol for a Multisite...

Area of Science:

• Pediatric infectious diseases
• Vaccinology
• Epidemiology

Background:

• Understanding COVID-19 vaccine effectiveness in children is crucial for public health policy.
• Assessing SARS-CoV-2 (the virus that causes COVID-19) incidence and severity in pediatric populations is essential.
• Guiding healthcare professionals in advising parents on managing COVID-19 in children.

Purpose of the Study:

• To describe the objectives and methods of the Pediatric Research Observing Trends and Exposures in COVID-19 Timelines (PROTECT) study.
• To estimate SARS-CoV-2 incidence and COVID-19 vaccine effectiveness (VE) in children aged 6 months to 17 years.
• To analyze differences in SARS-CoV-2 infection and vaccine response between children and adolescents.

Main Methods:

• A longitudinal, prospective pediatric cohort study initiated in July 2021 across four US locations.
• Enrollment of approximately 2305 children with data collection over a 2-year period.
• Weekly self-collected nasal specimens for SARS-CoV-2 and influenza testing via RT-PCR, with electronic medical record linkage for vaccination verification.

Main Results:

• Data collection commenced in July 2021 and is projected to conclude in spring 2023.
• As of April 13, 2022, 2371 children have been enrolled in the PROTECT study.
• Enrollment remains active across all participating study sites.

Conclusions:

• PROTECT study data will yield real-world estimates of COVID-19 vaccine effectiveness against infection in pediatric populations.
• The prospective cohort design offers a unique platform to understand SARS-CoV-2 incidence and clinical course.
• Findings will address key knowledge gaps to inform public health strategies regarding COVID-19 in children.