Real-World Effectiveness of Perinatal RSV Immunoprophylaxis
ConditionRSV Infection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 12
SponsorYale University
About this trial
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
This trial does not accept healthy volunteersQualifiers
≤ 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
Disqualifiers
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
Trial 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.
Trial design
Design model
Case-control
Time perspective
Retrospective
Treatments tested in this trial
Nirsevimab
DrugImmunoprophylaxis against RSV
Treatment groups
3,750 Participants
are divided into 3 treatment groupsGroup A: ARI Cases1 intervention
Group B: Healthy Controls1 intervention
Group C: ARI Controls1 intervention
Trial outcomes
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.
Time frame
Up to 5 yearsSecondary outcomes
1
Relative effectiveness of RSV immunoprophylaxis by viral groups or clades.
A case-only analysis in which investigators compare the immune status among cases infected with RSV group A versus B and assess the relative effectiveness of immunization. For this analysis, logistic regression will be used to control for the time of testing and other relevant confounders.
Time frame
Up to 5 years2
Kinetics of the innate and adaptive immune responses
The proportion of innate and adaptive immune cells in infants with breakthrough infections will be compared to healthy matched controls and test-negative controls. The frequency and phenotypic differences of peripheral blood immune cells during acute and convalescent blood of RSV+ infants who were both immunized and unimmunized will also be compared.
Time frame
Up to 5 yearsSponsors and contacts
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Yale University
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Source ClinicalTrials.gov