Investigator Studies Program (MISP): Respiratory Syncytial Virus (RSV)
Effective November 2019, the Respiratory Syncytial Virus (RSV) Investigator Initiated Studies Program (MISP) Committee will accept proposals within our current areas of interest (AOI) up to May 18, 2020. 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 following areas are of interest to Investigator Studies Program Committee:
Pediatrics
  • Immunity:
    • Translational research studies evaluating immune response to severe RSV disease in infants, including immune responses that may be related to the development of airway hyper-reactivity/recurrent reactive airway disease.
    • Studies that advance the understanding of immune response including correlates of immune protection (or levels that are judged protective for severe disease or even for sequelae) against RSV infection in infants/young children, including maternal antibody, passive immunization and alterations due to underlying medical/surgical conditions.
    • Studies, including modeling, that address timing of RSV neutralizing mAb administration with respect to RSV season, infant age and associated risk factors for RSV disease
  • Virology:
    • Studies evaluating RSV subgroup-specific (RSV A and RSV B) epidemiology, burden of illness and strain sequence heterogeneity of RSV infection in infants 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
  • Epidemiology:
    • 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 health care resource use and health-economic burden 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 to assess loss of work hours for parents/guardians and emotional stress
Adults
  • Immunity:
    • Studies that advance the understanding of immune response including correlates of immune protection against RSV infection in adults.
    • 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 and severity of disease by age and underlying medical conditions.
  • Virology:
    • Studies evaluating the subgroup-specific (RSV A and RSV B) epidemiology and burden of illness of RSV infection in adults ≥18 years of age, including pregnant women, adults with underlying cardiopulmonary conditions and older adults (≥60 years) in regions, countries or populations in which these data are limited.
  • Epidemiology:
    • Studies evaluating the health care resource use and health-economic burden of RSV infection in adults ≥18 years of age, including pregnant women, adults with underlying cardiopulmonary conditions and older adults (≥60 years) in regions, countries or populations in which these data are limited.
    • Studies investigating the role of RSV in the exacerbation of chronic obstructive pulmonary disease (COPD)
Both Pediatrics and Adults
  • Studies examining the sensitivity and specificity of case definitions for RSV lower respiratory tract infection (LRTI), RSV acute respiratory infection and RSV disease severity in pediatrics and in adults
  • Studies evaluating the sensitivity and specificity of sample collection methods (for example mid-turbinate swabs, naso-pharyngeal swabs, nasal washes) for nucleic acid-based RSV diagnostics
  • RSV subgroup-specific (RSV A and RSV B) laboratory surveillance studies in regions, countries or populations in which these data are limited, especially if RSV samples can also be sequenced to ascertain F protein heterogeneity in currently circulating strains
    • And of special interest, in a given season do the elderly and infants/children within a particular community have the same RSV strain circulations?
  • In addition to RSV, generation of incidence rate data and diagnostics (clinical criteria and molecular detection) for other respiratory viruses, for example influenza, para-influenza virus (PIV) and human metapneumovirus (hMPV), with a view to the development of a virus-specific surveillance testing panel
  • Studies on antimicrobial consumption in RSV disease and the potential of prophylaxis to reduce antimicrobial consumption
  • Studies that advance the understanding of bacterial co-infection and RSV in pediatrics and adults, including epidemiology, impact on seasonal incidence rates, healthcare resource use and costs

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

Critical Activities and Timelines:

Deadline Dates/Activity Review Cycle
Full Protocol Submission with Detailed Budget May 18, 2020
Final Comments to Investigator July 18, 2020


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.