Supporting Pediatric RSV Clinical Trials Through Close Epidemiological Surveillance During the SARS-CoV-2 Pandemic

Area of Science:

• Immunology
• Pediatrics
• Infectious Diseases

Background:

• Respiratory Syncytial Virus (RSV) poses a significant threat to infant health.
• The COVID-19 pandemic altered global disease patterns, including RSV epidemiology.
• Clesrovimab is an investigational extended half-life monoclonal antibody designed for infant RSV protection.

Purpose of the Study:

• To evaluate the efficacy and safety of Clesrovimab for protecting infants against RSV.
• To adapt clinical trial strategies in response to pandemic-influenced RSV seasonality.

Main Methods:

• Clinical trials were conducted to assess Clesrovimab's protective capabilities.
• Near real-time data monitoring was employed to track RSV activity.
• Enrollment strategies were dynamically adjusted based on observed RSV trends.

Main Results:

• RSV activity was minimal globally in 2020 due to pandemic-related measures.
• RSV resurgence patterns varied in 2021, with early onset in some regions and delayed onset in others.
• These epidemiological shifts necessitated modifications to trial enrollment.

Conclusions:

• The pandemic significantly impacted RSV epidemiology, requiring adaptive trial management.
• Dynamic monitoring and flexible enrollment strategies are crucial for conducting vaccine and antibody trials during public health crises.
• Clesrovimab trials demonstrated the need for adaptable approaches to ensure participant safety and data integrity.