EngageZone : Investigator Studies Program (MISP)

Investigator Studies Program (MISP): Respiratory Syncytial Virus (RSV)

Effective November 2022, the Respiratory Syncytial Virus (RSV) Investigator Initiated Studies Program (MISP) Committee will accept protocols within our current areas of interest (AOI) up to May 8, 2023. This is a competitive process that will be conducted by the RSV MISP Review Committee. Decisions will be made on the basis of scientific merit and strategic fit within the AOI. Please review the critical activities and abide by the timelines as outlined below. The program requests that investigators specify how they will support diversity in enrollment to include traditionally underrepresented minorities/ethnic groups.

The following areas are of interest to Investigator Studies Program Committee:
Pediatrics

Immunity:
- Studies, including modeling, that address timing of RSV neutralizing mAb administration with respect to to maternal RSV vaccination, RSV season, transmission, infant age and/or associated risk factors for RSV disease.
- Studies that advance the understanding of immune responses including correlates of immune protection (or levels that are judged protective for severe disease or even for sequelae) against RSV infection in infants, toddlers and young children, including maternal antibody, passive/active immunization, active vaccination (including novel vaccines and combinations), and alterations due to underlying conditions.
Virology:
- Studies evaluating RSV subgroup-specific (RSV A and RSV B) epidemiology, burden of illness and strain sequence heterogeneity of RSV infection in infants, toddlers and young children, especially very preterm and late preterm (29-35 weeks gestational age) infants and healthy near-full term (35+ weeks gestational age) infants in regions, countries or populations in which these data are limited
- Studies evaluating resistance to RSV monoclonal antibodies and vaccines, including:
- The Human Nose Organoid respiratory virus model: including the air-liquid interface.
Epidemiology:
- Sensitivity and specificity of case definitions for RSV-associated lower respiratory tract infection, acute respiratory infection, bronchiolitis and disease severity.
- Studies that advance the understanding of bacterial co-infection in RSV disease, including antimicrobial usage and AMR.
- Primary data collection evaluating the population-based incidence of all-cause respiratory infections and respiratory readmission after initial RSV admission; healthcare-associated RSV in countries or regions where data are limited
- Studies in infants to determine risk factors for recurrent wheezing/reactive airway following RSV infection, with attention to age at primary RSV infection and severity of RSV disease
- Studies evaluating the population-based incidence of medically-attended RSV, health care resource use and direct and indirect costs of RSV infection in infants and young children, especially very preterm and late preterm (22-35 weeks gestational age) infants and healthy near-full term (35+ weeks gestational age) infants in regions, countries or populations in which these data are limited. Can include studies that include loss of work hours for parents/guardians and emotional stress.
- Descriptive studies of the proportion of medically attended bronchiolitis and RSV infection that is accompanied by acute otitis media (AOM) including complications, and the direct costs of medically attended bronchiolitis and RSV visits with and without AOM.
- Studies that compare the percentage of respiratory specimens positive for RSV with the incidence of medically attended RSV in tropical and temperate regions.
- Understanding the reservoirs of RSV (as there is no animal host).
- Changes in the seasonality and impact of non-RSV respiratory viruses

Adults

Immunity:
- Studies that advance the understanding of immune response including correlates of immune protection against RSV infection in the elderly.
- Studies that advance the understanding of how alterations of an established RSV immune response, including immune senescence, effect of the risk of new RSV acquisition (consider severity of disease by age and underlying medical conditions).
- Incidence of RSV infections and hospitalizations in elderly adults residing in assisted living facilities in the US and ex-US
- Impact of protection of infants on disease in adults

Pediatrics and Adults

Inter-relationships between RSV and common respiratory viruses, especially studies that explore: (i) viral interference, (ii) shifts in RSV epidemiology, (iii) immunological markers of infection and disease, (iv) diagnosis of viral respiratory tract infection, (v) the role of metagenomics, transcriptomics and bio-informatics.
Studies that advance the understanding of bacterial co-infection and RSV, including epidemiology, impact on seasonal incidence rates, healthcare resource use and costs.
Studies on antimicrobial consumption in RSV disease and the potential for prophylaxis to reduce antimicrobial consumption and stewardship.
Studies that advance the understanding of immune responses including correlates of immune protection (or levels that are judged protective for severe disease or even for sequelae) against RSV infection in older adults, passive immunization, active vaccination/immunization, and variability due to underlying conditions.

Please complete a protocol with detailed budget via Visiontracker, the Company's on-line study management system (in US) or your MSD country representative (outside US). The protocols will be collectively reviewed and selected by the RSV MISP Review Committee.

Critical Activities and Timelines:

Deadline Dates/Activity	1^st Review Cycle
Protocol Submission with Detailed Budget	May 8, 2023
Final Comments to Investigator	August 7, 2023

MISP Information
This site is intended for US investigators only. Investigators outside of the US interested in submitting research proposals to the Investigator Studies Program should contact their local MSD office.