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10/10/2023  |   11:15 AM - 11:40 AM   |  6619

Creation of the CMV Transmission and Immune Tracking (TransmIT) Study Based on Collaboration and Community Engagement

Abstract Summary

A major risk factor for congenital CMV infection is exposure to young children during pregnancy. While early studies first described the epidemiology of CMV transmission in large group settings, more recent studies performed in alternative childcare centers and using more advanced experimental and data analysis approaches have not yet been done. To address this need, UMass Chan Medical School and Moderna, Inc. initiated a research collaboration in March 2021 to create the CMV Transmission and Immune Tracking (TransmIT) Study. The study aims to understand 1) patterns of CMV transmission among children in large care programs and to their household members and 2) virologic and immunologic parameters associated with reduced viral shedding in saliva and urine. Stage I focuses on infrastructure development, including the network of childcare centers, digital study platform, data management systems, and experimental pipelines. Preliminary data from Stage I will include prevalence of saliva CMV shedding at each center and a qualitative analysis of key discussions. Stage II involves longitudinal sample collection for viral genome sequencing, population genetics, and immune response studies. Community engagement practices and a diverse Community Advisory Board have been critical features of study development to optimize partnerships with centers and families. Guiding principles such as trust, dignity, and scholarship underlie interactions among study team members and with centers, their families, and study participants. Highlights and lessons learned from the collaborative design process of the CMV TransmIT Study will be shared.

Learning Objectives

  • To understand the priorities and activities of the CMV TransmIT Study design process
  • To appreciate the role of community engagement in developing a research study involving family-centered sites
  • To recognize the value and limitations of academic-industry research collaboration

Presentation

3440589_16069LauraGibson.pdf

Handouts

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Presenters


Karen Del'Olio | Author, Co-Author

karen.del'olio@umassmed.edu;
Karen Del’Olio, MPH is Research Program Manager for the CMV TransmIT Study at UMass Chan Medical School where she assists to lead study development and implementation and serve as a liaison between the study team and its partners. Karen is a mixed methods researcher with experience in academia and the biotech/pharmaceutical industry encompassing such areas as community based participatory research, community engagement and partnership building, participant and community partner recruitment and retention and working collaboratively with Community Advisory Boards, key informant experts and community partners. She received her Master's degree in Public Health from the University of Massachusetts.

ASHA DISCLOSURE

Financial - Receives Salary for Other activities from Moderna Therapuetics, Inc..  

Nonfinancial - No relevant nonfinancial relationship exists.

AAA DISCLOSURE

Financial - Receives support from Moderna Therapeutics, Inc. for fund research.  


John Diaz-Decaro | Author, Co-Author

John.Diaz-Decaro@modernatx.com;
Dr. Diaz-Decaro is Director and Lead Epidemiologist for Moderna’s mRNA-1647 CMV vaccine candidate. John supports all epidemiology-related activities for the CMV development program, including addressing evidence gaps in the field, highlighting the direct and indirect benefits of CMV vaccination, and supporting federal and state discussions on the importance of newborn screening. He received his PhD from the UCLA Fielding School of Public Health.

ASHA DISCLOSURE

Financial -

Nonfinancial -

AAA DISCLOSURE

Financial - No relevant financial relationship exists.


Timothy Kowalik | Co-Author

timothy.kowalik@umassmed.edu;
Timothy Kowalik, Ph.D. has been studying CMV since 1990. Prior to CMV research, he studied the genetics of bluetongue virus, a pathogen of ruminants including cattle, during his graduate training at Utah State University. Upon obtaining his PhD, he moved to North Carolina for postdoctoral studies at the University of North Carolina School of Medicine and then at Duke University Medical School. In 1996, he joined the faculty at the University of Massachusetts Medical, where is currently an Associate Professor of Microbiology and Physiological Systems.

ASHA DISCLOSURE

Financial -

Nonfinancial -

AAA DISCLOSURE

Financial - No relevant financial relationship exists.


Elizabeth Orvek | Co-Author

elizabeth.orvek@umassmed.edu;
N/A

ASHA DISCLOSURE

Financial -

Nonfinancial -

AAA DISCLOSURE

Financial - No relevant financial relationship exists.


Lauren Howe | POC-Point of Contact

lauren.howe@umassmed.edu;
N/A

ASHA DISCLOSURE

Financial - Receives Consulting fee for Consulting from Moderna Therapeutics, Inc..  

Nonfinancial - No relevant nonfinancial relationship exists.

AAA DISCLOSURE

Financial - Receives support from Moderna Therapeutics, Inc. for I am a consultant on the CMV TransmIT Study, which is funded by Moderna. The study is based at UMass Chan Medical School and the PI is Laura Gibson (senior author on the abstract).  


Kelsey Woods | Co-Author

kelsey.woods1@umassmed.edu;
N/A

ASHA DISCLOSURE

Financial -

Nonfinancial -

AAA DISCLOSURE

Financial - No relevant financial relationship exists.


Syed Naeem | Author, Co-Author

syed.naeem@umassmed.edu;
N/A

ASHA DISCLOSURE

Financial -

Nonfinancial -

AAA DISCLOSURE

Financial - No relevant financial relationship exists.


Cynthia Callaghan | Co-Author

cindi.callaghan@umassmed.edu;
N/A

ASHA DISCLOSURE

Financial -

Nonfinancial -

AAA DISCLOSURE

Financial - No relevant financial relationship exists.


Annie Geiger | Co-Presenter, Author, Co-Author

annie.geiger1@umassmed.edu;
Annie is a third-year medical student at UMass Chan Medical School. She received her master's degree in Pathology from the University of Cambridge and her Bachelor of Science in Biological Sciences from Cornell University.

ASHA DISCLOSURE

Financial - No relevant financial relationship exists.

Nonfinancial - No relevant nonfinancial relationship exists.

AAA DISCLOSURE

Financial - Receives support for I have received a small grant from the Infectious Diseases Society of America (IDSA) Grants for Emerging Researchers Program. I am not sure if this requires disclosure..  


Susan Druker | Co-Author

susan.druker@gmail.com;
N/A

ASHA DISCLOSURE

Financial -

Nonfinancial -

AAA DISCLOSURE

Financial - No relevant financial relationship exists.


Bruce Barton | Co-Author

bruce.barton@umassmed.edu;
N/A

ASHA DISCLOSURE

Financial -

Nonfinancial -

AAA DISCLOSURE

Financial - No relevant financial relationship exists.


Thejas Suvarna | Co-Author

suvarnaT@careevolution.com;
N/A

ASHA DISCLOSURE

Financial -

Nonfinancial -

AAA DISCLOSURE

Financial - No relevant financial relationship exists.


Emma Harman | Co-Author

emma.harman@careevolution.com;
N/A

ASHA DISCLOSURE

Financial - Receives Salary for Employment from CareEvolution.  

Nonfinancial - No relevant nonfinancial relationship exists.

AAA DISCLOSURE

Financial - Receives support from CareEvolution for Employment: I receive a salary from CareEvolution..  


Kelley Bridges | Co-Author

kelley.bridges@careevolution.com;
N/A

ASHA DISCLOSURE

Financial -

Nonfinancial -

AAA DISCLOSURE

Financial - No relevant financial relationship exists.


Summer Schrader | Co-Author

summer.schrader@careevolution.com;
N/A

ASHA DISCLOSURE

Financial -

Nonfinancial -

AAA DISCLOSURE

Financial - No relevant financial relationship exists.


Madeleine Hayden | Co-Author

madeleine.hayden@modernatx.com;
N/A

ASHA DISCLOSURE

Financial -

Nonfinancial -

AAA DISCLOSURE

Financial - No relevant financial relationship exists.


Sandeep Basnet | Co-Author

sandeep.basnet@modernatx.com;
N/A

ASHA DISCLOSURE

Financial -

Nonfinancial -

AAA DISCLOSURE

Financial - No relevant financial relationship exists.


Lori Panther | Co-Author

lori.panther@modernatx.com;
Lori Panther, MD, MPH is Senior Director of Clinical Development at Moderna, Inc., based in Cambridge, MA, USA. Dr. Panther is the Clinical Lead for Moderna’s investigational cytomegalovirus (CMV) vaccine program. Prior to joining Moderna in 2016, Dr. Panther was Assistant Professor of Medicine at Harvard Medical School and Associate Director for Clinical Research of the Fenway Institute at Beth Israel Deaconess Medical Center in Boston, MA, where she directed NIH- and industry-sponsored early- and late-phase vaccine trials and interventional trials of modalities to prevent sexually transmitted infections. Dr. Panther completed her Internal Medicine residency and chief residency at University of California, San Francisco, CA, USA; her Infectious Diseases fellowship at University of Washington, Seattle, WA, USA; and her Master of Public Health degree at the Harvard School of Public Health, Boston, MA, USA. Her research was focused on mucosal immunology of the genital tract in mother-to-child HIV transmission.

ASHA DISCLOSURE

Financial -

Nonfinancial -

AAA DISCLOSURE

Financial - No relevant financial relationship exists.


Laura Gibson | Primary Presenter

laura.gibson@umassmed.edu;
The current Med/Peds division chief, Laura returned to UMass Memorial Medical Center for a fellowship in Infectious Diseases after completing her Med/Peds residency at Baystate Medical Center. She is a graduate of Yale University and the University of Massachusetts Medical School. She remained at UMass after finishing her fellowship in 2001 to pursue research on cellular immune responses to human cytomegalovirus and other herpesviruses. She also serves on the general and transplant Infectious Diseases services in both the Departments of Medicine and Pediatrics.

ASHA DISCLOSURE

Financial - Receives Consulting fee,Grants for Membership on advisory committee or review panels,Independent contractor from Moderna Therapeutics, Inc.  

Nonfinancial - Has a Professional (Sci Adv Board (paid activity before 2019)) relationship for Volunteer membership on advisory committee or review panels.  

AAA DISCLOSURE

Financial - Receives support from Moderna Therapeutics, Inc for Grant funding for research being presented No Scientific Advisory Board activity since 2019.