Real-World Effectiveness of Perinatal RSV Immunoprophylaxis

Last updated: October 3, 2024
Sponsor: Yale University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Respiratory Syncytial Virus (Rsv) Infection

Respiratory Syncytial Virus (Rsv)

Treatment

Nirsevimab

Clinical Study ID

NCT06172660
2000036550
1R01AI179874-01
  • Ages < 12
  • All Genders

Study 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?

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ≤ 12 months of age at the time of presentation for evaluation for an acuterespiratory infection (ARI).

  • Documentation of an ARI, which is defined as an acute onset (<10 days) illness thatincludes: 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, persistentchest pain, pale, gray, hypoxia, clinical or radiographic evidence of pneumonia orrespiratory distress syndrome.

  • Residents of Connecticut

Exclusion

Exclusion Criteria:

  • 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

To be eligible for inclusion in the study as a healthy control, an individual must meet all of the following criteria:

  • 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).

Study Design

Total Participants: 3750
Treatment Group(s): 1
Primary Treatment: Nirsevimab
Phase:
Study Start date:
October 01, 2024
Estimated Completion Date:
December 30, 2028

Study Description

This will be a large-scale case-control study aiming to evaluate the effectiveness of perinatal RSV immunoprophylaxis. Cases and controls will be identified using active surveillance in both inpatient and outpatient clinical sites of the Yale New Haven Health System. Investigators will enroll patients seeking health care for acute respiratory illness and confirm RSV infection using approved molecular assays. Data will be collected from multiple sources, including health records, interviews, immunization registries, and population-based surveys. Investigators will generate estimates of effectiveness for each type of immunization used, disaggregated by time from immunization, disease severity, and sociodemographic characteristics (Aim 1). Investigators will also perform genetic characterization of all RSV viruses in the study, monitor the genetic diversity of the virus over time, and quantify the relative effectiveness of immunoprophylaxis against various viral lineages (Aim 2). Finally, investigators will collect acute and convalescent blood from a subset of infants and employ a single-cell and multi-omics approach to study the dynamics of the innate and adaptive immune responses during RSV infection and explore the molecular mechanisms that contribute to immunoprophylaxis failure (Aim 3).

Connect with a study center

  • Yale Child Health Research Center

    New Haven, Connecticut 06519
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.