Real-World Effectiveness of Perinatal RSV Immunoprophylaxis

NCT06172660 | Recruiting

• 2 other identifiers: 20000365501R01AI179874-01
• Study Type: observational
• Target: 3,750
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to continue evaluating how well the RSV vaccines work as they are currently being used in routine clinical practice. Some of the questions that the investigators hope to answer with this study are: 1) What is the overall effectiveness of these vaccines? 2) How long does immunity last? 3) How effective are the vaccines against new strains? 3) Does the vaccine's effectiveness vary by age?

Conditions

RSV Infection

Outcome Measures

Primary Outcomes (1)

• Overall effectiveness of RSV immunoprophylaxis

  The overall effectiveness of each immunoprophylactic strategy (monoclonal antibodies and maternal immunization) will be estimated separately. Logistic regression models will be used for analysis, with the outcome being case/control status and immunization status as the main predictor, controlling for known confounders.

  Up to 5 years

Secondary Outcomes (2)

• Relative effectiveness of RSV immunoprophylaxis by viral groups or clades.

  Up to 5 years

• Kinetics of the innate and adaptive immune responses

  Up to 5 years

Study Arms (3)

ARI Cases

Cases will be defined as infants ≤12 months old who had a clinical encounter for acute respiratory illness (ARI) and tested positive for RSV using polymerase chain reaction (PCR).

Drug: Nirsevimab

Healthy Controls

Healthy controls will be individually matched to enrolled vaccine failures (immunized and RSV+) by date of birth (±1 month), sex, and immunoprophylactic agent received (i.e., maternal vaccine or monoclonal antibody).

Drug: Nirsevimab

ARI Controls

Controls will be individuals with ARI who test negative for RSV and will be frequency matched based on time and clinical setting.

Drug: Nirsevimab

Interventions

Nirsevimab DRUG

Immunoprophylaxis against RSV

Also known as: RSV vaccines

ARI Cases; ARI Controls; Healthy Controls

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Eligible participants will include those who have a medically-attended ARI at one of the inpatient or ambulatory recruitment sites affiliated with the Yale New Haven Health System. Investigators will enroll males and females of all racial and ethnic groups meeting the inclusion criteria.

You may qualify if:

• ≤ 12 months of age at the time of presentation for evaluation for an acute respiratory infection (ARI).
• Documentation of an ARI, which is defined as an acute onset (\<10 days) illness that includes: At least two of the following symptoms: fever (measured or subjective), chills, rigors, myalgia, headache, sore throat, nausea or vomiting, diarrhea, fatigue, congestion OR any one of the following: cough, shortness of breath, difficulty breathing, olfactory disorder, taste disorder, confusion, persistent chest pain, pale, gray, hypoxia, clinical or radiographic evidence of pneumonia or respiratory distress syndrome.
• Residents of Connecticut

You may not qualify if:

• Illness duration of \>10 days at the time of respiratory specimen collection, measured from the date of the first symptom of the current acute illness.
• Parents/guardians are not able to provide informed consent
• Immunized against RSV ≤ 12 months of age
• Residents of Connecticut
• Match an enrolled case that was a vaccine failure by date of birth (±1 month), sex, and immunoprophylactic agent received (i.e., maternal vaccine vs mAb).

Sponsors & Collaborators

• Yale University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Yale Child Health Research Center

New Haven, Connecticut, 06519, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

3,750 participants will be enrolled in this study. They will provide respiratory samples for the identification of viruses. One hundred patients will provide acute and convalescent blood.

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

nirsevimab; Respiratory Syncytial Virus Vaccines

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Carlos R Oliveira, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos R Oliveira, MD

CONTACT

203-785-5474; carlos.oliveira@yale.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: December 15, 2023
• Study Start: October 28, 2024
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)