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Authors
Kaplonek, Paulina
Bertera, Harry
Lee, Diana W.
Cizmeci, Deniz
Yu, Wen-Han
Wu, Kai
Chalkias, Spyros
Wahid, Rahnuma
Edwards, Darin
Alter, Galit
Henry, Carole
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Clinical Trials BETA
Clinical trials referenced in this document:
nct04470427 at ClinicalTrials.govDocuments that mention this clinical trial
Covid-19 vaccine trial protocols released
https://doi.org/10.1136/bmj.m4058
SARS-CoV-2 vaccines in patients with SLE
https://doi.org/10.1136/lupus-2021-000479
IgG4 Neutralization and Sustained Total IgG Fc-Effector Functions Following Repeated SARS-CoV-2 Vaccination with mRNA-1273
https://doi.org/10.1007/s40121-026-01303-w
Covid-19 vaccines and treatments: we must have raw data, now
https://doi.org/10.1136/bmj.o102
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Funding
Funding for this research was provided by:
Moderna, Inc.
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Article History
Received: 13 November 2025
Accepted: 12 January 2026
First Online: 1 February 2026
Declarations
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: Paulina Kaplonek, Harry Bertera, Diana W. Lee, Deniz Cizmeci, Wen-Han Yu, Kai Wu, Spyros Chalkias, Rahnuma Wahid, Darin Edwards and Carole Henry are employees of Moderna, Inc., and hold stock/stock options in the company. Galit Alter has no conflicts of interest to declare.
: This study (ClinicalTrials.gov Identifier NCT04470427) was conducted in accordance with the principles of the Declaration of Helsinki, International Council for Harmonisation Good Clinical Practice (ICH-GCP) guidelines, and all applicable local regulatory requirements. The study protocol, informed consent forms, and related study materials were reviewed and approved by the Advarra Institutional Review Board (Columbia, Maryland, USA) and by local institutional review boards or independent ethics committees at participating sites, as applicable. All participants provided written informed consent prior to enrollment.
