Investigator Studies Program (MISP): Respiratory Syncytial Virus (RSV)
Effective October 2021, the Respiratory Syncytial Virus (RSV) Investigator Initiated Studies Program (MISP) Committee will accept protocols within our current areas of interest (AOI) up to May 2, 2022. This is a competitive process that will be conducted by the RSV Vaccine MISP. 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 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 immunization 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 monoclonal antibodies.
  • Epidemiology:
    • RSV epidemiology before, during or after the SARS-CoV-2 pandemic, including viral co-infections.
    • Sensitivity and specificity of case definitions for RSV lower respiratory tract infection, acute respiratory infection and disease severity.
    • Studies that advance the understanding of bacterial co-infection in RSV disease.
    • Primary data collection evaluating the incidence of all-cause respiratory infections and respiratory readmission after initial RSV admission.
    • 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 that advance the understanding of bacterial co-infection in RSV disease.
    • Studies evaluating the 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 includes 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).
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, affect of the risk of new RSV acquisition (consider severity of disease by age and underlying medical conditions).
Pediatrics and Adults
  • Inter-relationships between RSV and SARS-CoV-2/COVID-19, 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 evaluating the sensitivity and specificity of sample collection methods (for example mid-turbinate swabs, naso-pharyngeal swabs, nasal washes) for nucleic acid-based diagnostics.
  • In addition to RSV, generation of incidence data and diagnostics (clinical criteria and molecular detection) for other respiratory viruses, and the potential for detecting viral co-infections.
  • 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 anti-viral agents for RSV treatment and prophylaxis in animals and humans with a particular emphasis on PK/PD relationships.
  • 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 and variability due to underlying conditions.
  • Studies evaluating guidelines for prophylaxis/prevention.

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

Critical Activities and Timelines:

Deadline Dates/Activity 1stReview Cycle
Protocol Submission with Detailed Budget May 2, 2022
Final Comments to Investigator August 2, 2022


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.