j - JOUR AU - Gabashvili, Irene S PY - 2022 DA - 2022/11/4 TI - COVID-19疫苗对突破性感染的不良事件发生率和影响:代表性不足群体的分散观察研究JO - JMIR Form Res SP - e41914 VL - 6 IS - 11 KW - COVID-19 KW - COVID-19疫苗KW -疫苗不良事件KW -突破性感染KW -分散参与性研究KW -老年人KW -老年人KW -医疗服务不足人群KW -老龄化KW -老年人群KW -疫苗接种KW -遗传差异KW -微生物组差异KW -免疫力受损AB -背景:尽管继续努力改善临床研究中服务不足群体的纳入，但多样性方面的差距仍然存在。在面对COVID-19大流行等前所未有的复杂问题时，特殊人群的参与尤为重要。更好地了解不同人群中与免疫反应相关的因素将促进未来的预防和治疗方法。目的:本研究的目的是调查导致COVID-19免疫接种后不良事件的潜在因素。研究人群包括来自农村地区、转型国家和那些医学上未得到充分研究的成年人，年龄范围很广。方法:研究从COVID-19大流行期间建立的同伴支持网络演变而来。参与者是通过在线社区和健康社区以数字方式招募的。一些参与者自愿担任研究调查员，协助线下招募和安全监测。 Individuals who consented to participate were asked to share their vaccination experiences either using constantly evolving web-based surveys or via one-on-one communication. Inferential statistical analysis to estimate differences between study groups was performed using parametric and nonparametric tests. Results: Of 1430 participants who shared their vaccination experiences, 648 had outcome measures at their 1.5-year follow-up. Significant differences were found between age groups, types of vaccine adverse events (VAEs), incidences of breakthrough infections, and health conditions linked to the microbiome. Pairwise comparisons showed that VAEs interfering with daily activities were significantly higher in both younger (18-59 years) and older age groups (80-100 years, P<.001) than in the 60-79–year age group. Short-term VAEs were associated with lower incidence of breakthrough COVID-19 infections relative to those who reported either minimal or long-term adverse events (P<.001). A genetic origin was suggested for some adverse reactions. Conclusions: The findings of this study demonstrate that vaccine adverse reactions in older individuals are being overlooked, and the incidence of VAEs impairing immunity may be higher than previously perceived. Better preventive measures are needed for all those at risk for life-threatening and long-term adverse events due to vaccination. Supportive community-based studies focusing on these populations could add important data to the current body of knowledge. Further and more comprehensive studies should follow. Trial Registration: ClinicalTrials.gov NCT04832932; https://clinicaltrials.gov/ct2/show/NCT04832932 International Registered Report Identifier (IRRID): RR2-10.1101/2021.06.28.21256779 SN - 2561-326X UR - https://formative.www.mybigtv.com/2022/11/e41914 UR - https://doi.org/10.2196/41914 UR - http://www.ncbi.nlm.nih.gov/pubmed/36309347 DO - 10.2196/41914 ID - info:doi/10.2196/41914 ER -