Adult (non-pregnant)
IN SCOPE
- Increase understanding of burden of disease of RSV in adults considered at high risk for RSV disease due to advanced age or chronic medical conditions (for example, chronic cardiopulmonary disease, immunocompromised individuals, frail/long-term care/nursing home residents)
- Identify new risk factors that increase risk of severe RSV disease and describe their impact on disease burden
- Studies adding new information on previously identified risk factors for severe RSV disease and their impact on disease burden
- Studies describing/documenting complications and long-term sequela of RSV disease using appropriate control groups
- The role of RSV in non-respiratory diseases (such as cardiac disease, thromboembolic events, functional outcomes)
- Studies evaluating the sensitivity of RSV testing approaches/sampling
- Studies on strategies to improve RSV vaccine implementation and uptake in adults
- Increase understanding of immune response to RSV infection in adults considered at high risk for RSV disease due to chronic medical conditions and in older adults
OUT OF SCOPE
- Interventional, safety, effectiveness, or immunogenicity studies related to vaccine use
- Incidence studies (although collaborative research proposals can be considered)
- Any studies that do not fit at least one of the in-scope criteria listed above
Maternal Immunization
IN SCOPE
Disease burden in infants/children
- RSV burden of disease in infants by month of age in the first year of life
- RSV burden of disease in children from 12 months through 5 years of age
- RSV burden of disease in children 5 to 18 years of age including children with high-risk conditions
- Descriptive epidemiology of short, medium and long-term sequelae of RSV infection (e.g., otitis media, wheeze, asthma) from birth through age 5 years
- RSV serostatus in children from 2 through 5 years of age in the post-COVID era
- Descriptive epidemiology of all-cause respiratory illness in infants and children (including inpatient, outpatient, URI and LRTI) including detection of RSV and other viral and bacterial pathogens and codetections; data on HMPV and PIV1-4 are of particular interest
- Descriptive epidemiology of RSV transmission within households, especially between maternal (pregnant or postpartum) individuals and their infants & children [data on transmission to older adults (e.g., grandparents) also of interest]
- Association of pediatric RSV burden with indicators of equity (socioeconomic status, race, ethnicity, household characteristics, and geography)
RSV Burden Among Pregnant and Postpartum People
- Descriptive epidemiology of acute respiratory illness (medically attended and not medically attended) and detection of RSV among women of childbearing age, including during pregnancy and the first year postpartum, as well as RSV testing rates/patterns
- Maternal RSV infection during pregnancy associated with perinatal outcomes among individuals not vaccinated with RSVpreF
- Association of RSV burden with indicators of equity (socioeconomic status, race, ethnicity, household characteristics, and geography) among women of childbearing age, including during pregnancy and the first year postpartum
Maternal immunization – awareness, uptake, access, policy
- Acceptability and uptake of immunization during pregnancy including facilitators and barriers
- Ways to optimize equitable delivery of immunization to pregnant individuals, including quality metrics (healthcare system strengthening)
- Improving vaccine access for pregnant individuals, including addressing barriers for vaccine access
- Maternal immunization schedules and timing/patterns of administrations and coadministrations relative to prenatal care schedules
- Temporal alignment between maternal RSV vaccine seasonal recommendations and RSV seasonality
- Association of RSV maternal immunization with indicators of equity (socioeconomic status, race, ethnicity, household characteristics, and geography)
- Descriptive data on number and timing of births per person including interpregnancy intervals to help inform revaccination policy. In settings where revaccination in subsequent pregnancies is recommended, uptake of RSVpreF vaccine across subsequent pregnancies
Benefits of breastfeeding among individuals not vaccinated with RSVpreF
- Relationship between breastfeeding status/patterns and the frequency and severity of RSV-associated acute respiratory infection among infants from birth through 12 months of age among individuals not vaccinated with RSVpreF in pregnancy (e.g., benefits of naturally acquired RSV antibodies and/or breastfeeding in general)
- Relationship between breastfeeding status/patterns on hospital admission rates, length of stay, invasive or non-invasive mechanical ventilation or need for supplemental oxygen, antibiotic usage and acute otitis media among infants from birth through 12 months of age.
OUT OF SCOPE
- Vaccine effectiveness
- Safety studies
- Immunogenicity