Immune Correlates and Vaccine Immunobridging: Statistical Innovations, Challenges, and Opportunities

Por cuestiones de Copyright, este artículo solo puede ser consultado en Biblioteca Di Tella. Para concertar una cita, por favor escribir a repositorio@utdt.edu

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Autores principales: Carone, Marco, Wolock, Charles J., Olivas-Martínez, Antonio, Rotnitzky, Andrea, Gilbert, Peter B.
Formato: Artículo
Lenguaje:Inglés
Publicado: The Journal of Infectious Deseases (e- ISSN: 1537-6613) 2025
Materias:
Controlled risk
Correlates of protection
Data fusion
Randomized controlled trial
Variable importance analysis
Acceso en línea:https://repositorio.utdt.edu/handle/20.500.13098/13681
Aporte de:
Repositorio Digital Universidad Torcuato Di Tella de Universidad Torcuato Di Tella
id I57-R163-20.500.13098-13681
record_format dspace
spelling I57-R163-20.500.13098-136812025-10-14T05:03:15Z Immune Correlates and Vaccine Immunobridging: Statistical Innovations, Challenges, and Opportunities Carone, Marco Wolock, Charles J. Olivas-Martínez, Antonio Rotnitzky, Andrea Gilbert, Peter B. Controlled risk Correlates of protection Data fusion Randomized controlled trial Variable importance analysis Por cuestiones de Copyright, este artículo solo puede ser consultado en Biblioteca Di Tella. Para concertar una cita, por favor escribir a repositorio@utdt.edu In immunobridging, an investigational vaccine is approved based on a randomized trial of this vaccine versus an approved vaccine with an immunogenicity primary endpoint. Justification for immunobridging requires demonstration that meeting trial success criteria implies the investigational vaccine provides worthwhile protection against a relevant endpoint for a context of use. We consider recent statistical approaches whose integration supports immunobridging: (1) variable importance prediction analysis characterizing immune markers as correlates of risk; (2) controlled risk causal analysis evaluating markers as correlates of protection; and (3) transportability analysis combining data from efficacy and immunobridging trials for estimating investigational versus approved relative-vaccine efficacy. Por motivos relacionados con los derechos de autor este documento solo puede ser consultado en la Biblioteca Di Tella. Para reservar una cita podés ponerte en contacto con serviciosbiblio@utdt.edu. Si sos el autor de esta tesis y querés autorizar su publicación en este repositorio, podés ponerte en contacto con repositorio@utdt.edu. The Journal of Infectious Deseases (e- ISSN: 1537-6613) 2025-10-13T17:39:43Z 2025-09-16 info:eu-repo/semantics/article https://repositorio.utdt.edu/handle/20.500.13098/13681 eng The Journal of Infectious Deseases (e- ISSN: 1537-6613) info:eu-repo/semantics/restrictedAccess http://rightsstatements.org/page/InC/1.0/?language=es 5 p. application/pdf application/pdf
institution Universidad Torcuato Di Tella
institution_str I-57
repository_str R-163
collection Repositorio Digital Universidad Torcuato Di Tella
language Inglés
orig_language_str_mv eng
topic Controlled risk
Correlates of protection
Data fusion
Randomized controlled trial
Variable importance analysis
spellingShingle Controlled risk
Correlates of protection
Data fusion
Randomized controlled trial
Variable importance analysis
Carone, Marco
Wolock, Charles J.
Olivas-Martínez, Antonio
Rotnitzky, Andrea
Gilbert, Peter B.
Immune Correlates and Vaccine Immunobridging: Statistical Innovations, Challenges, and Opportunities
topic_facet Controlled risk
Correlates of protection
Data fusion
Randomized controlled trial
Variable importance analysis
description Por cuestiones de Copyright, este artículo solo puede ser consultado en Biblioteca Di Tella. Para concertar una cita, por favor escribir a repositorio@utdt.edu
format Artículo
author Carone, Marco
Wolock, Charles J.
Olivas-Martínez, Antonio
Rotnitzky, Andrea
Gilbert, Peter B.
author_facet Carone, Marco
Wolock, Charles J.
Olivas-Martínez, Antonio
Rotnitzky, Andrea
Gilbert, Peter B.
author_sort Carone, Marco
title Immune Correlates and Vaccine Immunobridging: Statistical Innovations, Challenges, and Opportunities
title_short Immune Correlates and Vaccine Immunobridging: Statistical Innovations, Challenges, and Opportunities
title_full Immune Correlates and Vaccine Immunobridging: Statistical Innovations, Challenges, and Opportunities
title_fullStr Immune Correlates and Vaccine Immunobridging: Statistical Innovations, Challenges, and Opportunities
title_full_unstemmed Immune Correlates and Vaccine Immunobridging: Statistical Innovations, Challenges, and Opportunities
title_sort immune correlates and vaccine immunobridging: statistical innovations, challenges, and opportunities
publisher The Journal of Infectious Deseases (e- ISSN: 1537-6613)
publishDate 2025
url https://repositorio.utdt.edu/handle/20.500.13098/13681
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