Investigator Studies Program (MISP): Pneumococcus
Effective December 2020, the Pneumococcus Investigator Studies Program (MISP) Committee will accept proposals within our current areas of interest (AOI) up to May 7, 2021. This is a competitive process that will be conducted by the Pneumococcus MISP in 2021. 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
  • Identify disease-causing pneumococcal serotypes using the Merck Research Laboratories (MRL)/MSD serotype-specific urinary antigen detection (SSUAD) or other assays
  • 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 10-, 14-, 15-, 20-, 24-valent PCVs
      • Emerging non-vaccine serotypes
    • Carriage and disease manifestations of interest include:
      • Nasopharyngeal carriage and oro-pharyngeal carriage
      • Acute otitis media in children
      • Non-bacteraemic pneumonia and all-cause pneumonia
      • Invasive pneumococcal disease (IPD)
    • Antimicrobial resistance (AMR) of both vaccine and non-vaccine serotypes
  • 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

Vaccination-related and immunology
  • Impact of paediatric PCV vaccination programmes or adult PPSV23 programmes on the prevalence and serotype distribution of nasopharyngeal and/or oro-pharyngeal carriage
  • Epidemiology of pneumococcal serotypes contained in PPSV23 in settings where paediatric 13-valent PCV and/or adult PPSV23 have been introduced, including sequential series, transitional programmes and jurisdictions with shared clinical decision-making
  • 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 revaccination of adults with PPSV23
  • Epidemiological studies of the effectiveness and durability of sequential use of PCVs and PPSV23 in adults
  • 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
  • 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, etc), comparing incidence in those who had received pneumococcal vaccination and those who had not, with a view to increasing vaccination rates
  • Consideration of implementation science, process improvements, barriers
  • 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 1st Review Cycle
Protocol Submission with Detailed Budget May 7, 2021
Final Comments to Investigator July 7, 2021

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.