Andrew Natenshon

Model-Informed Dose Selection for mRNA-3927 in Participants with Propionic Acidemia (PA)

Wei Gao, Tao He, Hanbin Li, Min Liang et autres

Objectives: To develop population pharmacokinetic/pharmacodynamic (PKPD) models for mRNA-3927 to characterize PCCA mRNA pharmacokinetics and the pharmacodynamic response of disease-related biomarkers, 3-hydroxypropionic acid (3-HP) and 2-methylcitric acid (2-MC), in participants with propionic acidemia (PA), and to use these models to support dose …

Connecting research and community: a methodological framework for investigating CMV transmission in childcare settings

Karen Del’Olio, Anne Geiger, Lauren Christine Howe, Delaney Platia et autres

The CMV Transmission and Immune Tracking (TransmIT) Study was developed to address critical gaps in understanding of cytomegalovirus (CMV) transmission dynamics in early education and care (EEC) settings. This two-stage, community-engaged study design integrates EEC center partnerships, digital study platforms, and data …

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Safety and Immunogenicity of a Messenger RNA–Based Cytomegalovirus Vaccine in Healthy Adults: Results From a Phase 1 Randomized Clinical Trial

Carlos A. Fierro, Daniel C. Brune, Marian Shaw, Howard Schwartz et autres

BACKGROUND: This phase 1 trial evaluated the safety, reactogenicity, and immunogenicity of mRNA-1647, a messenger RNA (mRNA)-based cytomegalovirus (CMV) vaccine, in CMV-seronegative and -seropositive adults. METHODS: Participants were randomly assigned to receive 30, 90, 180, or 300 µg of mRNA-1647 or placebo …

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2892. Safety and Immunogenicity of mRNA-1647, an mRNA-Based Cytomegalovirus Vaccine in Healthy Adults: Results of a Phase 2, Randomized, Observer-Blind, Placebo-Controlled, Dose-Finding Trial

Lori Panther, Sandeep Basnet, Carlos A. Fierro, Daniel C. Brune et autres

Abstract Background A safe and effective method to protect against cytomegalovirus (CMV) infection is a public health priority. mRNA-1647 is an investigational mRNA-based vaccine against CMV consisting of 6 mRNA sequences encoding 2 CMV antigens (glycoprotein B and the pentameric glycoprotein complex) …

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A systematic literature review of the economic and healthcare resource burden of cytomegalovirus

John D Diaz-Decaro, Evan R. Myers, Jacek Mucha, Monika Neumann et autres

OBJECTIVE: Cytomegalovirus (CMV) can infect individuals at any age, including infants, who may contract it from infected mothers (congenital CMV [cCMV]). Whereas CMV infection is typically asymptomatic or causes mild illness in healthy individuals, infection can result in severe outcomes in immunocompromised …

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A Qualitative Assessment of Clinical Practice Guidelines and Patterns for Congenital Cytomegalovirus in the United States

Stephanie Kalb, John D Diaz-Decaro, Harout K. Tossonian, Andrew Natenshon et autres

Cytomegalovirus (CMV) infection during pregnancy may result in long-term health problems for children with congenital CMV (cCMV). Currently, no prevention or treatment interventions are approved by the Food and Drug Administration for a cCMV indication. Healthcare provider and public awareness is low, …

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A systematic literature review on the humanistic burden of cytomegalovirus

John D Diaz-Decaro, Evan R. Myers, Jacek Mucha, Monika Neumann et autres

OBJECTIVE: Cytomegalovirus (CMV) infection is typically asymptomatic in healthy individuals; however, certain populations are vulnerable to infection and may develop serious sequelae. CMV infection may also have a broad impact on humanistic outcomes, including patient health status and quality of life (QoL). …

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A systematic literature review of the economic and healthcare resource burden of cytomegalovirus

John D Diaz-Decaro, Evan R. Myers, Jacek Mucha, Monika Neumann et autres

Cytomegalovirus (CMV) can infect individuals at any age, including infants, who may contract it from infected mothers (congenital CMV [cCMV]). Whereas CMV infection is typically asymptomatic or causes mild illness in healthy individuals, infection can result in severe outcomes in immunocompromised individuals …

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A systematic literature review on the humanistic burden of cytomegalovirus

John D Diaz-Decaro, Evan R. Myers, Jacek Mucha, Monika Neumann et autres

Cytomegalovirus (CMV) infection is typically asymptomatic in healthy individuals; however, certain populations are vulnerable to infection and may develop serious sequelae. CMV infection may also have a broad impact on humanistic outcomes, including patient health status and quality of life (QoL). We …

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112. Interim Results From a Phase 2, Randomized, Observer-Blind, Placebo-Controlled, Dose-Finding Trial of an mRNA-Based Cytomegalovirus Vaccine in Healthy Adults

Lori Panther, Carlos A. Fierro, Daniel C. Brune, Richard Leggett et autres

Abstract Background Cytomegalovirus (CMV) is the most common congenital viral infection and can cause severe long-term health consequences, including hearing loss and neurodevelopmental delay. A safe and effective method for prevention of CMV infection is an unmet need and public health priority. …

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A systematic literature review of the global seroprevalence of cytomegalovirus: possible implications for treatment, screening, and vaccine development

Karen B. Fowler, Jacek Mucha, Monika Neumann, Witold Lewandowski et autres

BACKGROUND: Cytomegalovirus (CMV) is a common pathogen that affects individuals of all ages and establishes lifelong latency. Although CMV is typically asymptomatic in healthy individuals, infection during pregnancy or in immunocompromised individuals can cause severe disease. Currently, treatments are limited, with no …

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POSC130 Global Economic Burden of Congenital Cytomegalovirus: A Systematic Literature Review

John D Diaz-Decaro, Evan R. Myers, Ján Mucha, Marcus A. Neumann et autres

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