Real-world effectiveness of perinatal RSV immunoprophylaxis: protocol for a test-negative case-control study.
Camila Aparicio Llorente, Aanchal Wats, Barbara L Araujo...
https://pubmed.ncbi.nlm.nih.gov/41856594Actively Recruiting
Age: 0 - 12Months
All Genders
ID06172660
Real-World Effectiveness of Perinatal RSV Immunoprophylaxis
Led by Yale University · Updated on 2025-08-14
3750
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the real-world effectiveness of perinatal RSV immunoprophylaxis in infants up to 12 months old. The study aims to understand how well these vaccines work in routine clinical practice, including their overall effectiveness, duration of immunity, effectiveness against new RSV strains, and variations in effectiveness by age. This large-scale case-control study uses active surveillance to identify infants with respiratory illness and confirm RSV infection through molecular tests. The study includes infants who received immunoprophylaxis such as maternal vaccines or the drug Nirsevimab, comparing those who tested positive for RSV (cases) with healthy controls matched by birth date, sex, and type of immunization, as well as with controls who have respiratory illness but test negative for RSV. Data will be gathered from health records, interviews, immunization registries, and surveys. The study also involves genetic analysis of RSV viruses and detailed immune response studies using blood samples from a subset of infants. Participants will be infants aged 12 months or younger residing in Connecticut who seek care for acute respiratory illness. Investigators will collect clinical data, laboratory test results, and immune response information over up to five years. The main outcomes measured include the overall effectiveness of RSV immunoprophylaxis and its effectiveness against different viral strains, along with immune system dynamics. Safety monitoring and follow-up will continue during this time to provide a comprehensive assessment of vaccine performance in everyday clinical use.
CONDITIONS
Brief Title
Real-World Effectiveness of Perinatal RSV Immunoprophylaxis
Who Can Participate
Age: 0 - 12Months
All Genders
Eligibility Criteria
You may qualify if you...
- Children 12 months of age or younger at the time of evaluation for acute respiratory infection (ARI).
- Documented ARI defined as acute onset illness (<10 days) with at least two symptoms such as fever, chills, headache, sore throat, nausea, diarrhea, fatigue, congestion, or at least one symptom like cough, shortness of breath, difficulty breathing, or clinical evidence of pneumonia or respiratory distress.
- Residency in Connecticut.
- For healthy controls: immunized against RSV and matched to a vaccine failure case by birth date (±1 month), sex, and immunoprophylactic agent received.
You will not qualify if you...
- Illness lasting more than 10 days at the time of respiratory specimen collection.
- Parents or guardians unable to provide informed consent.
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surveillance
Duration - Up to 5 years
Participants are observed through active surveillance in inpatient and outpatient clinical sites to identify RSV infection and collect data from health records, interviews, and registries.
Periodic visits depending on clinical encounters
Sample Collection
Duration - Up to 5 years
Acute and convalescent blood samples are collected from a subset of infants to study immune responses and molecular mechanisms related to RSV infection and immunoprophylaxis.
1 to 2 visits for blood collection depending on participant subgroup
Trial Site Locations
Total: 1 location
1
Yale Child Health Research Center
New Haven, Connecticut, United States, 06519
Actively Recruiting
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Research Team
C
Carlos R Oliveira, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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