RSV InfectionNCT06172660
Real-World Effectiveness of Perinatal RSV Immunoprophylaxis
An observational study of RSV Infection, run by Yale University at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- RSV Infection
- What is being tested?
- Nirsevimab
- Type of treatment
- Vaccines
- How many people
- 3,750 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2024to 30 Dec 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 months
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- ≤ 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yale Child Health Research Center
New Haven, Connecticut, 06519
Research Coordinator, 203-785-5474
About this study
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?
Read the detailed 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).
- Conditions
- RSV Infection
- Being tested
- Nirsevimab
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NirsevimabDrug
Also called RSV vaccines
Immunoprophylaxis against RSV
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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. Receives: Drug: Nirsevimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 5 years
Secondary outcomes (2)
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.
Measured: Up to 5 years
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.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start28 Oct 2024
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RSV InfectionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 3,750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos R Oliveira, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172660
- Sponsor's protocol ID
- 2000036550
- Other IDs
- 1R01AI179874-01
- Status last verified
- Oct 2026
- First submitted
- 6 Dec 2023
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aparicio Llorente C, Wats A, Araujo BL, Moniz Ganem J, Oliva IO, Xu H, Brodsky NN, Lucas CL, Aronson PL, Grubaugh ND, Breban M, Redmond S, Shapiro ED, Niccolai LM, Weinberger DM, Oliveira CR. Real-world effectiveness of perinatal RSV immunoprophylaxis: protocol for a test-negative case-control study. BMJ Open. 2026 Mar 19;16(3):e114524. doi: 10.1136/bmjopen-2025-114524.
PubMed 41856594