Abstract：
BACKGROUND: Despite continuing efforts to improve the inclusion of underserved groups in clinical research, gaps in diversity remain. Participation of special populations is especially important when facing problems of unprecedented complexity such as the COVID-19 pandemic. A better understanding of factors associated with the immune response in diverse populations would advance future preventive and curative approaches.
OBJECTIVE: The objective of this study was to investigate the factors potentially responsible for adverse events following COVID-19 immunization. The study population included adults from rural areas, transitional countries, and those with medically understudied conditions, across a broad age range.
METHODS: The study evolved from peer support networks developed during the COVID-19 pandemic. Participants were recruited digitally through online neighborhood and health communities. Some of the participants volunteered as study investigators assisting with offline recruitment and safety monitoring. 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.
BACKGROUND: ClinicalTrials.gov NCT04832932; https://clinicaltrials.gov/ct2/show/NCT04832932.
UNASSIGNED: RR2-10.1101/2021.06.28.21256779.
OBJECTIVE: The objective of this study was to investigate the factors potentially responsible for adverse events following COVID-19 immunization. The study population included adults from rural areas, transitional countries, and those with medically understudied conditions, across a broad age range.
METHODS: The study evolved from peer support networks developed during the COVID-19 pandemic. Participants were recruited digitally through online neighborhood and health communities. Some of the participants volunteered as study investigators assisting with offline recruitment and safety monitoring. 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.
BACKGROUND: ClinicalTrials.gov NCT04832932; https://clinicaltrials.gov/ct2/show/NCT04832932.
UNASSIGNED: RR2-10.1101/2021.06.28.21256779.
摘要：
背景：尽管继续努力改善在临床研究中纳入服务不足的群体，多样性的差距仍然存在。当面对诸如COVID-19大流行等前所未有的复杂性问题时，特殊人群的参与尤为重要。更好地了解与不同人群的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可能导致COVID-19免疫后不良事件的因素。研究人群包括来自农村地区的成年人，转型国家,那些医学上没有充分研究的人，在广泛的年龄范围内。
方法：这项研究是从COVID-19大流行期间开发的对等支持网络演变而来的。参与者通过在线社区和健康社区进行数字化招募。一些参与者自愿担任研究调查员，协助离线招募和安全监控。同意参加的个人被要求使用不断发展的基于网络的调查或通过一对一的交流来分享他们的疫苗接种经验。使用参数和非参数检验进行推断统计分析以估计研究组之间的差异。
结果：在分享疫苗接种经验的1430名参与者中，648人在1.5年的随访中有结果指标。发现年龄组之间存在显着差异，疫苗不良事件(VAE)的类型，突破性感染的发生率，和与微生物组相关的健康状况。配对比较显示，在年轻（18-59岁）和老年（80-100岁，P<.001）高于60-79岁年龄组。与报告轻微或长期不良事件的患者相比，短期VAE与突破性COVID-19感染的发生率较低相关(P<.001)。一些不良反应被认为是遗传起源。
结论：这项研究的结果表明，老年人的疫苗不良反应被忽视，并且损害免疫力的VAE的发生率可能高于以前的感知。所有因接种疫苗而面临危及生命和长期不良事件风险的人都需要采取更好的预防措施。针对这些人群的支持性社区研究可以为当前的知识体系增加重要数据。应该进行进一步和更全面的研究。
背景：ClinicalTrials.govNCT04832932;https://clinicaltrials.gov/ct2/show/NCT04832932。
未经评估：RR2-10.1101/2021.06.28.21256779。
目的：本研究的目的是调查可能导致COVID-19免疫后不良事件的因素。研究人群包括来自农村地区的成年人，转型国家,那些医学上没有充分研究的人，在广泛的年龄范围内。
方法：这项研究是从COVID-19大流行期间开发的对等支持网络演变而来的。参与者通过在线社区和健康社区进行数字化招募。一些参与者自愿担任研究调查员，协助离线招募和安全监控。同意参加的个人被要求使用不断发展的基于网络的调查或通过一对一的交流来分享他们的疫苗接种经验。使用参数和非参数检验进行推断统计分析以估计研究组之间的差异。
结果：在分享疫苗接种经验的1430名参与者中，648人在1.5年的随访中有结果指标。发现年龄组之间存在显着差异，疫苗不良事件(VAE)的类型，突破性感染的发生率，和与微生物组相关的健康状况。配对比较显示，在年轻（18-59岁）和老年（80-100岁，P<.001）高于60-79岁年龄组。与报告轻微或长期不良事件的患者相比，短期VAE与突破性COVID-19感染的发生率较低相关(P<.001)。一些不良反应被认为是遗传起源。
结论：这项研究的结果表明，老年人的疫苗不良反应被忽视，并且损害免疫力的VAE的发生率可能高于以前的感知。所有因接种疫苗而面临危及生命和长期不良事件风险的人都需要采取更好的预防措施。针对这些人群的支持性社区研究可以为当前的知识体系增加重要数据。应该进行进一步和更全面的研究。
背景：ClinicalTrials.govNCT04832932;https://clinicaltrials.gov/ct2/show/NCT04832932。
未经评估：RR2-10.1101/2021.06.28.21256779。
