Notice of Intent to Sole Source - The Children's Hospital Corporation -

In this Task, the Contractor shall evaluate protection attributed to nirsevimab and maternal RSV vaccine receipt against severe RSV by leveraging representative enrollment of patients hospitalized with RSV and suitable matched controls as noted below. The Contractor shall use the existing infrastructure of the Overcoming COVID-19 Study Network and leverage the existing protocol. The specific objectives related to RSV product effectiveness are to:

1) Evaluate effectiveness of nirsevimab and maternal RSV vaccination against severe RSV disease in infants and against any RSV hospitalization in the 2nd year of life, by product, and assess duration of protection; and 2) Assess RSV clinical progression among ICU-admitted infants by nirsevimab or maternal vaccination receipt status within predetermined age groups.

In performing this Task, the Contractor shall: Representatively enroll case-infants <2 years of age admitted to the intensive care unit (ICU) or step-down unit (SDU) with severe RSV disease. Target enrollment goals for RSV product/vaccine effectiveness cases and controls with respiratory viral LRTI is approximately 1500-1600 patients <12 months of age in each group, and approximately 1200-1300 representatively enrolled patients between 8 months and 2 years of age who were hospitalized in either the ward or ICU.

Consecutively enroll RSV patients to facilitate enrollment for product effectiveness investigations while utilizing existing resources specified in the core tasks. SARS-CoV-2-positive and RSV-positive case-patients may share the same non-COVID-19, non-RSV ARI control, although RSV VE controls shall be matched to RSV case-patients by level of care (e.g., ICU vs ward admissions) in addition to site, age group, and time of admission, as specified in the core task.

Among enrolled patients for this Task, collect detailed information on clinical severity and course, including mechanical ventilation, oxygenation index, duration of respiratory support, and extracorporeal membrane oxygenation support. Maternal vaccination status or infant nirsevimab receipt status must be verified through a combination of any of the following:

hospital EMR (from the birth hospital if records cannot be verified at treating hospital), state IIS (registry) of patient’s state of residence; pediatrician records; mother’s prenatal medical records; or pharmacy, or other CDC-approved sources of verification determined on a case-by-case basis. Collect and submit newly drawn or discarded blood/sera samples to assess immune response in RSV cases and controls. Revise the existing Protocol, Forms, and Data Dictionary to incorporate the activities of this Task.

Include enrollment and progress in Biweekly Enrollment and Quarterly Summary Reports as due for the Surveillance and VE Evaluation. The Contractor will ship blood specimens periodically, but no less than quarterly, to CDC or CDC-Designated Laboratory. Provide Monthly Interim Datasets and Final Dataset.