Investigator Studies Program (MISP): Respiratory Syncytial Virus (RSV)
Effective November 2020, 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, 2021. 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:
- Studies, including modeling, that address timing of RSV neutralizing mAb administration with respect to RSV season (including perennial 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.
- Translational research studies evaluating immune response to RSV disease in infants, toddlers and young children, including immune responses that may be related to the development of airway hyper-reactivity/recurrent reactive airway disease and the development of asthma.
- 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 palivizumab resistance and/or implementation of palivizumab guidelines
- Studies assessing RSV epidemiology before, during or after the SARS-CoV-2 pandemic, comparing the epidemiology with historical data to quantify the differences, if any, including viral co-infections.
- Studies examining the sensitivity and specificity of case definitions for RSV lower respiratory tract infection (LRTI), 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 evaluating the incidence of medically-attended RSV, 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
Pediatrics and Adults
- 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.
- Studies that explore 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 to understand which infection is occurring first: RSV, SARS-CoV-2, influenza, other, and which help to understand the microbiome.
- Studies that explore the impact of measures against SARS-CoV-2, including social distancing, quarantining and other public health measures, reduced engagement with healthcare providers, changes in diagnostic activities, and the use of anti-virals and/or anti-inflammatories.
- 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.
Please complete a protocol with detailed budget via Visiontracker, the Company's on-line study management system (in US). The proposals will be collectively reviewed and selected by the RSV MISP Committee.
Critical Activities and Timelines:
|Protocol Submission with Detailed Budget
||May 18, 2021
|Final Comments to Investigator
||July 18, 2021
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