Investigator Studies Program (MISP): Pneumococcus
Effective September 2021, the Pneumococcus Investigator Studies Program (MISP) Committee will accept protocols within our current areas of interest (AOI) up to March 8, 2022. This is a competitive process that will be conducted by the Pneumococcus MISP in 2022. 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:

Disease, epidemiology, sero-epidemiology, antimicrobial resistance (AMR) and molecular aspects
  • Evaluate the epidemiology, including sero-epidemiology, molecular epidemiology, burden-of-disease, and health economic impact of infections caused by Streptococcus pneumoniae
    • Serotypes of interest include those in the:
      • Licensed 23-valent pneumococcal polysaccharide vaccine (PPSV23)
      • Licensed 10-valent and 13-valent pneumococcal conjugate vaccines (PCVs)
      • Investigational PCVs
      • Emerging non-vaccine serotypes
    • Carriage and disease manifestations of interest include:
      • Nasopharyngeal carriage and oro-pharyngeal carriage
      • Acute otitis media and chronic suppurative otitis media in children
      • Non-bacteraemic pneumonia and all-cause pneumonia
      • Invasive pneumococcal disease (IPD) including pneumococcal pneumonia and empyema
    • Antimicrobial resistance (AMR) of both vaccine and non-vaccine serotypes
  • Identify disease-causing pneumococcal serotypes in adults using the Merck Research Laboratories (MRL) (USA and Canada) and MSD (ex-USA/ex-Canada) serotype-specific urinary antigen detection (SSUAD) and/or other assays including salivary testing and surveillance
  • Examine the inter-relationship between Streptococcus pneumoniae and respiratory viruses
    • Including spatio-temporal patterns, seasonality, the microbiome, secondary bacterial infections and antimicrobial use
  • Document the impact of SARS-CoV-2 and COVID-19 on S. pneumoniae

Vaccine related and immunology
  • Immunogenicity of 15-valent PCV
  • Impact of pneumococcal vaccination programmes on serotype distribution
  • Incidence/prevalence of Streptococcus pneumoniae serotype 3, especially in settings where paediatric 13-valent PCV or other PCVs have been introduced
  • Evaluation of the effectiveness, population-level impact and health economic impact of pneumococcal vaccination
  • Advancement of the understanding of the immunology and vaccine response(s) with respect to immune correlates of protection and concomitant vaccination with a special emphasis on OPA and IgG responses
  • Exploration of possible synergies between pneumococcal vaccination and viral vaccination
    • Special interest in influenza or SARS-CoV-2 vaccination and at-risk groups
  • Measurement of immunological memory and durability of protective immune responses for both PPSV23 and PCVs in adults and/or children, appropriately stratified; correlates of protection in adults; alternate measures of vaccine response
  • Antibody characterization
  • Observations on SARS-CoV-2 testing following pneumococcal vaccination
  • Barriers to and facilitators of pneumococcal vaccination, including how to improve sequential vaccination
  • Comparison of pneumococcal disease incidence in at-risk populations (for example, HIV, HSCT, chronic renal disease, those receiving immunomodulators, etc), comparing incidence in those who had received pneumococcal vaccination and those who had not, with a view to increasing vaccination rates
  • Consideration of barriers to vaccination and vaccine hesitancy; health disparities and equity
  • Epidemiological studies that include social determinants related to both disease risk and pneumococcal vaccine uptake
  • The potential role of pneumococcal vaccines in reducing antimicrobial consumption and/or antimicrobial resistance, and their potential role in antimicrobial 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 Pneumococcus MISP Committee.

Critical Activities and Timelines:
Activity Review Cycle
Protocol Submission with Detailed Budget March 8, 2022
Final Comments to Investigator June 1, 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.