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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...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
American Medical Association
2023
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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 |
format | Online Article Text |
id | pubmed-9929699 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | American Medical Association |
record_format | MEDLINE/PubMed |
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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