Investigator Studies Program (MISP): HPV

Effective February 2023, the HPV Investigator Studies Program (MISP) Committee will accept protocol submissions within our current areas of interest (AOI) up to May 9, 2023. This is a competitive process that will be conducted by the HPV MISP 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:

Real-World-Value

• Studies to assess long term immune response to HPV vaccines and clinical outcomes in girls vaccinated during the Gavi demonstration programs in LMIC with different HIV disease burden

Implementation

• Studies that evaluate the success of different vaccination catch up strategies for adolescents and young adults
• Factors and interventions influencing HPV vaccination update (vaccine coverage rates) among adults (18-26 and 27+ years), including different delivery systems or points of vaccination
• Analysis of data to study potential increases in vaccine coverage rates and series completion when age at first does was changed to 9 compared to at age 11 to 14

Adults and selected sub-population

• Assessment of the HPV infection and related disease prevalence and incidence in adults (18-26 and 27+), including immunocompromised (e.g., HIV), MSM and other subpopulations at high risk

New Frontiers

• Epidemiological and/or molecular studies to assess whether vaccinating infected individuals prevents transmission of infection to others

Please complete a Protocol Template and the Global Clinical FMV Budget template using the corresponding MISP templates via Visiontracker, the Company's on-line study management system (in US) or your MSD country representative (outside US). The protocols will be collectively reviewed and selected by the HPV MISP Review Committee.

Critical Activities and Timelines:

Activity	Review Cycle
Protocol Submission with Detailed Budget	May 9, 2023
Final Comments to Investigator	August 10, 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.