Abstract Details
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
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Presenters
Karen Del'Olio | Author, Co-Author
karen.del'olio@umassmed.edu;
Karen Del’Olio is a seasoned Research Program Manager and Community Engaged Research (CEnR) strategist with extensive expertise in mixed-methods research, epidemiology, and public health. With over two decades of experience across both academia and industry, her work has centered on advising public health professionals and enhancing research study design. Karen excels in stakeholder relations, regulatory affairs, community engagement, and recruitment and retention strategies. She is proficient in survey development, program evaluation, health literacy, and study branding, while ensuring participant-facing materials are accessible. Karen is dedicated to fostering collaboration between communities and researchers, making research both impactful and inclusive.
ASHA DISCLOSURE
Financial -
Nonfinancial -
AAA DISCLOSURE
Financial - No relevant financial relationship exists.
John Diaz-Decaro | Author, Co-Author
John.Diaz-Decaro@modernatx.com;
John Diaz-Decaro is a Senior Director and Lead Epidemiologist at Moderna, where he leads epidemiologic strategy for the development of vaccines targeting Epstein-Barr virus (EBV) and other latent viruses. His work supports clinical development for Moderna’s EBV and CMV vaccine programs. Dr. Diaz-Decaro plays a key role in advancing non-interventional studies to assess disease burden, including EBV-associated conditions such as infectious mononucleosis, multiple sclerosis and post-transplant lymphoproliferative disorder. He also contributes to Moderna’s CMV epidemiology research portfolio supporting work on studies focused on investigating infant outcomes associated with congenital CMV, as well as CMV transmission dynamics in daycare settings.
ASHA DISCLOSURE
Financial -
Nonfinancial -
AAA DISCLOSURE
Financial - No relevant financial relationship exists.
Timothy Kowalik | Co-Author
timothy.kowalik@umassmed.edu;
Timothy Kowalik, Ph.D. earned a BS in Biology from Belmont Abbey College, followed by an MS and PhD at Utah State University, where he studied the genetic relatedness of US serotypes of bluetongue virus. His postdoctoral work at UNC-Chapel Hill and Duke University focused on HCMV, cell cycle regulation, and viral transformation. In 1997, he joined UMass Chan Medical School as an Assistant Professor, where he researched HCMV virology and cell growth control, discovering a key receptor that defines CMV tropism. Dr. Kowalik has collaborated extensively on viral evolution and congenital transmission studies. He is currently the Dr. Marcellette G. Williams Distinguished Scholar, a tenured Full Professor in the Department of Microbiology and Fellow of the American Academy of Microbiology.
ASHA DISCLOSURE
Financial -
Nonfinancial -
AAA DISCLOSURE
Financial - No relevant financial relationship exists.
Elizabeth Orvek | Co-Author
elizabeth.orvek@umassmed.edu;
Elizabeth Orvek specializes in designing, developing and implementing data capture and management systems that incorporate robust quality controls to ensure accurate data entry. She oversaw the collection and validation of childcare center and child-level data, conducted routine quality assurance checks, and generated enrollment dashboards. Additionally, Ms. Orvek supported the study’s quantitative data analysis, prepared summary statistical reports, and ensured all data quality processes were completed prior to finalizing datasets for study analysis.
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 -
Nonfinancial -
AAA DISCLOSURE
Financial - No relevant financial relationship exists.
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
annie21geiger@gmail.com;
Annie is a first-year resident at the NYU Grossman School of Medicine Internal Medicine Residency Program. She received her medical degree from the University of Massachusetts Chan Medical School, her master's degree in Biological Sciences (Pathology) from the University of Cambridge and her Bachelor of Science in Biological Sciences from Cornell University with a minor in Inequality Studies. She has research experience in mycobacteria microbiology, Plasmodium parasite protein biology, and tick control methods. Her academic interests are in infectious diseases and community health education.
ASHA DISCLOSURE
Financial - Receives Grants for Other activities from Infectious Diseases Society of America.
Nonfinancial - Has a Institutional (Medical Student, graduated June 1, 2025) relationship for Other volunteer activities.
AAA DISCLOSURE
Financial - Receives support from Infectious Diseases Society of America, GERM program Moderna, Inc. UMass Chan Medical School for Primary author and presenter Annie Geiger received a grant from the Infectious Diseases Society of America, GERM program ($4,000) for this study in 2023. Co-author Dr. Laura Gibson received a grant from Moderna, Inc. for the CMV TransmIT Study; this study was conducted within the childcare center network of the CMV TransmIT Study. This study and the CMV TransmIT Study were also supported by UMass Chan Medical School..
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 -
Nonfinancial -
AAA DISCLOSURE
Financial - No relevant financial relationship exists.
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;
Sandeep Basnet is a former Director of Clinical Development, Infectious Disease at Moderna. During his tenure, he played a key role in advancing the CMV vaccine program, with notable contributions to the CMV TransmIT study, several epidemiologic studies and CMV clinical trials. At the time of this project, Sandeep Basnet was Director of Clinical Development for Moderna’s CMV program.
ASHA DISCLOSURE
Financial -
Nonfinancial -
AAA DISCLOSURE
Financial - No relevant financial relationship exists.
Lori Panther | Co-Author
lori.panther@modernatx.com;
Lori Panther is Vice President of Clinical Development, Infectious Disease at Moderna. She leads the clinical development of Moderna’s CMV vaccine candidate, mRNA-1647, currently in a pivotal Phase 3 trial with aim to evaluate the vaccine’s efficacy, safety, and immunogenicity for the prevention of primary CMV infection in women of childbearing age. She’s a board-certified infectious disease specialist, Dr. Panther brings deep clinical and scientific expertise to Moderna’s latent virus portfolio and plays a key role in advancing CMV vaccine development.
ASHA DISCLOSURE
Financial -
Nonfinancial -
AAA DISCLOSURE
Financial - No relevant financial relationship exists.
Laura Gibson | Primary Presenter
laura.gibson@umassmed.edu;
Laura Gibson is an Adult and Pediatric Infectious Disease physician at UMass Memorial Health and a Professor of Medicine and Pediatrics at UMass Chan Medical School in Worcester, MA. With over 20 years of experience as a physician-scientist, she combines patient care with translational research, focusing on cytomegalovirus (CMV) and other viruses in vulnerable populations, particularly infants with congenital CMV infection (cCMV). During the SARS-CoV-2 pandemic, she co-led the Clinical Studies Core (CSC) of the NIH RADx® Program at UMass Chan. The CSC aimed to identify and test point-of-care technologies for rapid SARS-CoV-2 detection in real-world environments.
ASHA DISCLOSURE
Financial - Receives Grants for Other activities from moderna.
Nonfinancial - No relevant nonfinancial relationship exists.
AAA DISCLOSURE
Financial - Receives support from moderna for grant funding that ended 12/31/24.