EngageZone : Investigator Studies Program (MISP)

Investigator Studies Program (MISP): Pneumococcus

Effective December 6, 2022, the Pneumococcus Investigator Studies Program (MISP) Committee will accept protocols within our current areas of interest (AOI) up to March 27, 2023. This is a competitive process that will be conducted by the Pneumococcus MISP in 2023. 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 and diseases caused by Streptococcus pneumoniae, including
- Characterization of breakthrough disease (eg understanding the mechanism, its extent, individual/public health impact, etc)
  - Also consider breakthrough disease in partially or fully vaccinated infants/children based upon age at the time of IPD, number of doses and which PCV given at what ages, and serotype of the IPD
Epidemiology and infection models for serotypes 15A, 15C, 16F, 23A, 23B, 24F, 31, 35B
Incidence / prevalence / molecular characterization of Streptococcus pneumoniae serotype 3
Comparison of pneumococcal disease incidence in at-risk populations (for example, HIV, HSCT, chronic renal disease, asplenia, those receiving immunomodulators etc), comparing incidence in those who had received pneumococcal vaccination and those who had not
The impact of culture enrichment techniques on pneumococcal surveillance
Molecular detection of S. pneumoniae especially in surveillance networks
Carriage and disease manifestations of interest include:

Nasopharyngeal carriage and oro-pharyngeal carriage in children
Adult carriage and transmission; transmission dynamics
Acute otitis media and chronic suppurative otitis media in children
Non-bacteraemic pneumonia and all-cause pneumonia in children and adults
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 our Company’s serotype-specific urinary antigen detection (SSUAD) and/or other assays including salivary testing
Examine the inter-relationship between Streptococcus pneumoniae and respiratory viruses including SARS-CoV-2, hMPV and RSV

Including disease severity, seasonality, the respiratory microbiome, secondary bacterial infections and antimicrobial use

Vaccine related and Immunology

Immunogenicity of PCVs in high risk populations
Immunologic characterization of antibody responses
Measuring, characterizing and understanding responses to pneumococcal exposure and vaccination:

Including antibody characterization, B cell memory evaluation, methods to determine the persistence of immune memory, correlates of protection, role of agglutinating antibodies

Additional immunological endpoints of interest
Impact of pneumococcal vaccination programmes on serotype distribution in both the pediatric and adult populations
- Including serotype replacement
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 with a special emphasis on OPA and IgG responses

Consider especially serotype 3

Human challenge studies
Measurement of immunological memory and durability of protective immune responses
Antibody measurement by broncho-alveolar lavage
B cells sourcing through tonsillectomy, adenoidectomy, lymph node aspiration, bone marrow aspiration
The potential role of pneumococcal vaccines in reducing antimicrobial consumption and/or antimicrobial resistance, and their potential role in antimicrobial stewardship
Future vaccine development; Approaches to overcome reduction of immune responses with higher valent vaccines, role of adjuvants in pneumococcal immune responses; Protein antigens

Vaccine program implementation / vaccine policy- could include barriers / facilitators to vaccination, VCR studies

Barriers to and facilitators of pneumococcal vaccination
Implementation science-based studies that help facilitate understanding of how best to implement multiple different PCVs in the recently/in the future changing landscape of vaccine product availability
Prevention of pneumococcal disease in LMICs, hard-to-reach populations, indigenous populations, and emerging risk populations
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

Visiontracker

Critical Activities and Timelines:

Activity	Review Cycle
Protocol Submission with Detailed Budget	March 27, 2023
Final Comments to Investigator	June 16, 2023

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.