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March 21, 2026BMJ OpenOpen Access

Real-world effectiveness of perinatal RSV immunoprophylaxis: protocol for a test-negative case–control study

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Authors

CLCamila Aparicio LlorenteAWAanchal WatsBABarbara L. Araujo

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Overview

Test-negative case–control study assesses RSV vaccine effectiveness in infants, indicating real-world intervention impact.

Key Points

  • To evaluate the effectiveness of perinatal RSV immunoprophylaxis in real-world conditions among infants with acute respiratory illness.
  • Conduct a test-negative case–control study over five years.
  • Include infants ≤12 months presenting with acute respiratory illness.
  • Collect data from electronic health records, caregiver surveys, and immunization registries.
  • Estimate vaccine effectiveness using multivariable logistic regression.
  • Perform full-genome sequencing on RSV-positive specimens.
  • Identify RSV-positive cases and RSV-negative controls for comparison.
  • Uncover potential immune-escape mutations in RSV variants.
  • Define immune responses related to breakthrough RSV infections.

Cite This Study

Llorente et al. (2026) studied this question.

synapsesocial.com/papers/69be36d46e48c4981c676060https://doi.org/10.1136/bmjopen-2025-114524
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