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Early vs Deferred Non–Messenger RNA COVID-19 Vaccination Among Chinese Patients With a History of Inactive Uveitis: A Randomized Clinical Trial

IMPORTANCE: Improper host response to COVID-19 vaccines could trigger immune-mediated adverse events. The question remains whether COVID-19 vaccination should be postponed until complete remission in patients with uveitis, a preexisting immune-related condition. OBJECTIVE: To compare recommendations...

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Autores principales: Zhong, Zhenyu, Wu, Qiuying, Lai, Yuxian, Dai, Lingyu, Gao, Yu, Liao, Weiting, Su, Guannan, Wang, Yao, Zhou, Chunjiang, Yang, Peizeng
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Medical Association 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9929699/
https://www.ncbi.nlm.nih.gov/pubmed/36787142
http://dx.doi.org/10.1001/jamanetworkopen.2022.55804
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author Zhong, Zhenyu
Wu, Qiuying
Lai, Yuxian
Dai, Lingyu
Gao, Yu
Liao, Weiting
Su, Guannan
Wang, Yao
Zhou, Chunjiang
Yang, Peizeng
author_facet Zhong, Zhenyu
Wu, Qiuying
Lai, Yuxian
Dai, Lingyu
Gao, Yu
Liao, Weiting
Su, Guannan
Wang, Yao
Zhou, Chunjiang
Yang, Peizeng
author_sort Zhong, Zhenyu
collection PubMed
description IMPORTANCE: Improper host response to COVID-19 vaccines could trigger immune-mediated adverse events. The question remains whether COVID-19 vaccination should be postponed until complete remission in patients with uveitis, a preexisting immune-related condition. OBJECTIVE: To compare recommendations for early and deferred COVID-19 vaccination with respect to uveitis outcomes. DESIGN, SETTING, AND PARTICIPANTS: This open-label, randomized clinical trial at a large, specialized teaching center for uveitis care in China enrolled unvaccinated patients with inactive uveitis between August 10, 2021, and February 22, 2022, with follow-up to June 6, 2022. INTERVENTIONS: Participants were randomly assigned to receive recommendation for early or deferred COVID-19 vaccination after complete remission of uveitis. Non–messenger RNA (non-mRNA) COVID-19 vaccines were available in China during the trial. MAIN OUTCOMES AND MEASURES: The primary outcome was the time to symptomatic uveitis worsening during 3 months of follow-up. Secondary outcomes included uveitis activity and best-corrected visual acuity at 3 months. RESULTS: Of the 543 participants (304 women [56.0%]; median age, 35 [IQR, 26-49] years), 262 were recommended for early vaccination and 281 for deferred vaccination. By month 3, 109 patients (41.6%) in the early group had been vaccinated compared with 14 (5.0%) in the deferred recommendation group. In the intention-to-treat population, the time to symptomatic uveitis worsening was shorter in the early group than in the deferred group (hazard ratio, 1.68 [95% CI, 1.09-2.59]; P = .01 by log-rank test). Changes in anterior chamber cells, vitreous haze, and best-corrected visual acuity from baseline to month 3 appeared similar in the 2 groups in the evaluable population after the month 3 in-person visit. CONCLUSIONS AND RELEVANCE: In this randomized clinical trial of patients with inactive uveitis, recommendation for early non-mRNA COVID-19 vaccination resulted in a higher incidence of self-reported symptomatic uveitis worsening with possible reporting bias compared with recommendation for deferred vaccination, but no adverse effects were observed in disease and visual prognosis at 3 months. These findings would be useful to guide the individual timing choices of non-mRNA COVID-19 vaccination in this clinically vulnerable population. TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR2100049467
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spelling pubmed-99296992023-02-16 Early vs Deferred Non–Messenger RNA COVID-19 Vaccination Among Chinese Patients With a History of Inactive Uveitis: A Randomized Clinical Trial Zhong, Zhenyu Wu, Qiuying Lai, Yuxian Dai, Lingyu Gao, Yu Liao, Weiting Su, Guannan Wang, Yao Zhou, Chunjiang Yang, Peizeng JAMA Netw Open Original Investigation IMPORTANCE: Improper host response to COVID-19 vaccines could trigger immune-mediated adverse events. The question remains whether COVID-19 vaccination should be postponed until complete remission in patients with uveitis, a preexisting immune-related condition. OBJECTIVE: To compare recommendations for early and deferred COVID-19 vaccination with respect to uveitis outcomes. DESIGN, SETTING, AND PARTICIPANTS: This open-label, randomized clinical trial at a large, specialized teaching center for uveitis care in China enrolled unvaccinated patients with inactive uveitis between August 10, 2021, and February 22, 2022, with follow-up to June 6, 2022. INTERVENTIONS: Participants were randomly assigned to receive recommendation for early or deferred COVID-19 vaccination after complete remission of uveitis. Non–messenger RNA (non-mRNA) COVID-19 vaccines were available in China during the trial. MAIN OUTCOMES AND MEASURES: The primary outcome was the time to symptomatic uveitis worsening during 3 months of follow-up. Secondary outcomes included uveitis activity and best-corrected visual acuity at 3 months. RESULTS: Of the 543 participants (304 women [56.0%]; median age, 35 [IQR, 26-49] years), 262 were recommended for early vaccination and 281 for deferred vaccination. By month 3, 109 patients (41.6%) in the early group had been vaccinated compared with 14 (5.0%) in the deferred recommendation group. In the intention-to-treat population, the time to symptomatic uveitis worsening was shorter in the early group than in the deferred group (hazard ratio, 1.68 [95% CI, 1.09-2.59]; P = .01 by log-rank test). Changes in anterior chamber cells, vitreous haze, and best-corrected visual acuity from baseline to month 3 appeared similar in the 2 groups in the evaluable population after the month 3 in-person visit. CONCLUSIONS AND RELEVANCE: In this randomized clinical trial of patients with inactive uveitis, recommendation for early non-mRNA COVID-19 vaccination resulted in a higher incidence of self-reported symptomatic uveitis worsening with possible reporting bias compared with recommendation for deferred vaccination, but no adverse effects were observed in disease and visual prognosis at 3 months. These findings would be useful to guide the individual timing choices of non-mRNA COVID-19 vaccination in this clinically vulnerable population. TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR2100049467 American Medical Association 2023-02-14 /pmc/articles/PMC9929699/ /pubmed/36787142 http://dx.doi.org/10.1001/jamanetworkopen.2022.55804 Text en Copyright 2023 Zhong Z et al. JAMA Network Open. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the CC-BY License.
spellingShingle Original Investigation
Zhong, Zhenyu
Wu, Qiuying
Lai, Yuxian
Dai, Lingyu
Gao, Yu
Liao, Weiting
Su, Guannan
Wang, Yao
Zhou, Chunjiang
Yang, Peizeng
Early vs Deferred Non–Messenger RNA COVID-19 Vaccination Among Chinese Patients With a History of Inactive Uveitis: A Randomized Clinical Trial
title Early vs Deferred Non–Messenger RNA COVID-19 Vaccination Among Chinese Patients With a History of Inactive Uveitis: A Randomized Clinical Trial
title_full Early vs Deferred Non–Messenger RNA COVID-19 Vaccination Among Chinese Patients With a History of Inactive Uveitis: A Randomized Clinical Trial
title_fullStr Early vs Deferred Non–Messenger RNA COVID-19 Vaccination Among Chinese Patients With a History of Inactive Uveitis: A Randomized Clinical Trial
title_full_unstemmed Early vs Deferred Non–Messenger RNA COVID-19 Vaccination Among Chinese Patients With a History of Inactive Uveitis: A Randomized Clinical Trial
title_short Early vs Deferred Non–Messenger RNA COVID-19 Vaccination Among Chinese Patients With a History of Inactive Uveitis: A Randomized Clinical Trial
title_sort early vs deferred non–messenger rna covid-19 vaccination among chinese patients with a history of inactive uveitis: a randomized clinical trial
topic Original Investigation
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9929699/
https://www.ncbi.nlm.nih.gov/pubmed/36787142
http://dx.doi.org/10.1001/jamanetworkopen.2022.55804
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