Investigator Studies Program (MISP): Vaccine Biology

Effective January 2021, the Investigator Studies Program Review Committee (MISP-RC) for Vaccine Biology will accept proposals within our current areas of interest (AOI) up to April 16, 2021. This is a competitive review process that will be conducted on May 7, 2021 by the Vaccine Biology MISP Review Committee. 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:

Overarching aim is to understand immunization biology in humans by studying the following:

• Antigens: Different forms of antigen can be considered for administration
  • Antigen identification and design
  • Vectors
  • Nucleic acids (DNA or mRNA or self-replicating mRNA)
  • Subunit/protein
  • Virus like particles or antigen display technologies
  • Attenuated pathogens as carriers (e.g., measles, Yellow Fever Virus, commensal bacteria)
• Studies of adjuvants in:
  • Raising mucosal immunity
  • Overcoming immature immunity in infants
  • Overcoming immunosenescence in elderly
  • Improving the quality and quantity of the immune response
  • Pathways that can be modulated to achieve desired immunological endpoints for different populations (especially in elderly, infants)
• Delivery systems:
  • Mucosal delivery (oral, dermal, subcutaneous, intranasal)
  • Pumps or implants for prolonged or timed release
  • Nano-technology
  • Intra-dermal administration of vaccine
  • Electroporation (nucleic acids)
  • Efficient delivery of nucleic acids into cells (non-electroporation-based methods)
  • Understanding the connection between mucosal compartments in humans
• Improving understanding of:
  • Correlates of protection
  • Biomarkers beyond standard serological and CMI measurements
  • How to improve cross presentation of antigen to other immune cells
  • Novel preclinical models that can better predict human immune response (beyond animal models)
• Microbiome:
  • Understanding the role of microbiome in modulating mucosal and systemic responses to vaccines in humans and non-human primates
  • Mining the microbiome/commensal bacteria as a source of identifying novel adjuvants
  • Use of commensal bacteria as vaccine vectors for delivery of antigens/adjuvants
  • Novel oral formulations to successfully deliver commensal bacteria into GI tract
• Potential use of microbiome as correlates of vaccine efficacy/correlates of protection

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 Vaccine Biology MISP Committee.

Critical Activities and Timelines:

Deadline Dates/Activity	Review Cycle
Protocol Submission with Detailed Budget	April 16, 2021
Final Comments to Investigator	June 30, 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.