首页 > 最新文献

Influenza and Other Respiratory Viruses最新文献

英文 中文
How Does the Burden of Respiratory Syncytial Virus Compare to Influenza in Spanish Adults? 在西班牙成年人中,呼吸道合胞病毒的负担与流感相比如何?
IF 4.3 4区 医学 Q1 INFECTIOUS DISEASES Pub Date : 2024-06-24 DOI: 10.1111/irv.13341
Federico Martinón-Torres, Clara Gutierrez, Ana Cáceres, Karin Weber, Antoni Torres

Background

Respiratory syncytial virus (RSV) and influenza infections cause significant annual morbidity and mortality worldwide in at-risk populations. This study is aimed at assessing hospital burden and healthcare resource utilization (HRU) of RSV and influenza in adults in Spain.

Methods

Data were obtained from the Projected Hospitalisation Database of inpatient episodes (ages: younger adults 18–50 and 51–64 years; older adults 65–74, 75–84, and ≥ 85 years) during 2015, 2017, and 2018 in Spanish public hospitals. Incidence, mean hospitalization, and HRU assessments, including length of stay (LOS), intensive care unit (ICU) usage, and age-standardized mortality rates, were collected and stratified by age group, with analyses focusing on the adult population (≥ 18 years old).

Results

Mean hospitalization rate in the population across all years was lower in individuals with RSV versus influenza (7.2/100,000 vs. 49.7/100,000 individuals). ICU admissions and median LOS were similar by age group for both viruses. Age-standardized mortality was 6.3/100,000 individuals and 6.1/100,000 individuals in patients with RSV and influenza, respectively, and mortality rates were similar in older adults (≥ 65 years) for both viruses.

Conclusions

RSV and influenza infection were associated with considerable HRU. There is a substantial disease burden for RSV infection in older adults ≥ 65 years. While RSV hospitalization rates in adults reported here appeared lower than influenza, RSV is still underdiagnosed in the hospital setting and its incidence might be similar to, or higher than, influenza.

背景:呼吸道合胞病毒(RSV)和流感感染每年都会在全球高危人群中造成严重的发病率和死亡率。本研究旨在评估西班牙成人感染 RSV 和流感的医院负担和医疗资源利用率(HRU):数据来自西班牙公立医院 2015、2017 和 2018 年住院病例预测数据库(年龄:18-50 岁和 51-64 岁的年轻成年人;65-74 岁、75-84 岁和≥85 岁的老年人)。收集了发病率、平均住院率和 HRU 评估,包括住院时间(LOS)、重症监护室(ICU)使用率和年龄标准化死亡率,并按年龄组进行了分层,分析重点是成年人群(≥ 18 岁):结果:与流感相比,RSV患者在所有年份的平均住院率较低(7.2/100,000 对 49.7/100,000)。两种病毒在不同年龄组的重症监护室入院率和中位住院日相似。RSV和流感患者的年龄标准化死亡率分别为6.3/100,000和6.1/100,000,两种病毒在老年人(≥65岁)中的死亡率相似:结论:RSV 和流感感染与相当大的 HRU 有关。在年龄≥ 65 岁的老年人中,RSV 感染造成了巨大的疾病负担。虽然报告的成人 RSV 住院率似乎低于流感,但在医院环境中,RSV 的诊断率仍然偏低,其发病率可能与流感相似或更高。
{"title":"How Does the Burden of Respiratory Syncytial Virus Compare to Influenza in Spanish Adults?","authors":"Federico Martinón-Torres,&nbsp;Clara Gutierrez,&nbsp;Ana Cáceres,&nbsp;Karin Weber,&nbsp;Antoni Torres","doi":"10.1111/irv.13341","DOIUrl":"10.1111/irv.13341","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Respiratory syncytial virus (RSV) and influenza infections cause significant annual morbidity and mortality worldwide in at-risk populations. This study is aimed at assessing hospital burden and healthcare resource utilization (HRU) of RSV and influenza in adults in Spain.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Data were obtained from the Projected Hospitalisation Database of inpatient episodes (ages: younger adults 18–50 and 51–64 years; older adults 65–74, 75–84, and ≥ 85 years) during 2015, 2017, and 2018 in Spanish public hospitals. Incidence, mean hospitalization, and HRU assessments, including length of stay (LOS), intensive care unit (ICU) usage, and age-standardized mortality rates, were collected and stratified by age group, with analyses focusing on the adult population (≥ 18 years old).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Mean hospitalization rate in the population across all years was lower in individuals with RSV versus influenza (7.2/100,000 vs. 49.7/100,000 individuals). ICU admissions and median LOS were similar by age group for both viruses. Age-standardized mortality was 6.3/100,000 individuals and 6.1/100,000 individuals in patients with RSV and influenza, respectively, and mortality rates were similar in older adults (≥ 65 years) for both viruses.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>RSV and influenza infection were associated with considerable HRU. There is a substantial disease burden for RSV infection in older adults ≥ 65 years. While RSV hospitalization rates in adults reported here appeared lower than influenza, RSV is still underdiagnosed in the hospital setting and its incidence might be similar to, or higher than, influenza.</p>\u0000 </section>\u0000 </div>","PeriodicalId":13544,"journal":{"name":"Influenza and Other Respiratory Viruses","volume":"18 6","pages":""},"PeriodicalIF":4.3,"publicationDate":"2024-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11194680/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141456528","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Monitoring Influenza C and D Viruses in Patients With Respiratory Diseases in Japan, January 2018 to March 2023 2018年1月至2023年3月日本呼吸道疾病患者中的丙型和丁型流感病毒监测。
IF 4.3 4区 医学 Q1 INFECTIOUS DISEASES Pub Date : 2024-06-24 DOI: 10.1111/irv.13345
Kohei Shimizu, Chiharu Kawakami, Yoko Matsuzaki, Seiichiro Fujisaki, Shiho Nagata, Hiroko Morita, Kayo Watanabe, Hideka Miura, Tomoko Momoki, Miwako Saikusa, Hiroki Ozawa, Makoto Kumazaki, Shuzo Usuku, Nobuko Tanaka, Ryuichi Senda, Ichiro Okubo, Shinji Watanabe, Hideki Hasegawa, Yoshihiro Kawaoka, Emi Takashita

Background

Influenza viruses can cause zoonotic infections that pose public health risks. Surveillance of influenza A and B viruses is conducted globally; however, information on influenza C and D viruses is limited. Longitudinal monitoring of influenza C virus in humans has been conducted in several countries, but there has been no long-term monitoring of influenza D virus in humans. The public health risks associated with the influenza D virus therefore remain unknown.

Methods

We established a duplex real-time RT-PCR to detect influenza C and D viruses and analyzed respiratory specimens collected from 2144 patients in Japan with respiratory diseases between January 2018 and March 2023. We isolated viruses and conducted hemagglutination inhibition tests to examine antigenicity and focus reduction assays to determine susceptibility to the cap-dependent endonuclease inhibitor baloxavir marboxil.

Results

We detected three influenza C viruses belonging to the C/Kanagawa- or C/Sao Paulo-lineages, which recently circulated globally. None of the specimens was positive for the influenza D virus. The C/Yokohama/1/2022 strain, isolated from the specimen with the highest viral RNA load and belonging to the C/Kanagawa-lineage, showed similar antigenicity to the reference C/Kanagawa-lineage strain and was susceptible to baloxavir.

Conclusions

Our duplex real-time RT-PCR is useful for the simultaneous detection of influenza C and D viruses from the same specimen. Adding the influenza D virus to the monitoring of the influenza C virus would help in assessing the public health risks posed by this virus.

背景:流感病毒可引起人畜共患病,对公共健康构成威胁。全球都在对甲型和乙型流感病毒进行监测,但有关丙型和丁型流感病毒的信息却很有限。一些国家已对人类感染的丙型流感病毒进行了纵向监测,但尚未对人类感染的丁型流感病毒进行长期监测。因此,与 D 型流感病毒相关的公共卫生风险仍然未知:我们建立了一种检测丙型和丁型流感病毒的双重实时 RT-PCR,并分析了 2018 年 1 月至 2023 年 3 月期间从日本 2144 名呼吸道疾病患者身上采集的呼吸道标本。我们分离了病毒,并进行了血凝抑制试验以检测抗原性,还进行了聚焦还原试验以确定对帽依赖性内切酶抑制剂巴洛沙韦 marboxil 的敏感性:结果:我们检测到三种丙型流感病毒,它们属于最近在全球流行的丙型/神奈川系或丙型/圣保罗系。没有一个样本对丁型流感病毒呈阳性反应。从病毒 RNA 负荷最高的标本中分离出的 C/ 横滨/1/2022 株属于 C/ 神奈川系,其抗原性与参考的 C/ 神奈川系毒株相似,并且对巴洛沙韦敏感:结论:我们的双重实时 RT-PCR 技术可用于同时检测同一样本中的丙型和丁型流感病毒。在监测丙型流感病毒的同时加入丁型流感病毒,将有助于评估该病毒对公众健康造成的风险。
{"title":"Monitoring Influenza C and D Viruses in Patients With Respiratory Diseases in Japan, January 2018 to March 2023","authors":"Kohei Shimizu,&nbsp;Chiharu Kawakami,&nbsp;Yoko Matsuzaki,&nbsp;Seiichiro Fujisaki,&nbsp;Shiho Nagata,&nbsp;Hiroko Morita,&nbsp;Kayo Watanabe,&nbsp;Hideka Miura,&nbsp;Tomoko Momoki,&nbsp;Miwako Saikusa,&nbsp;Hiroki Ozawa,&nbsp;Makoto Kumazaki,&nbsp;Shuzo Usuku,&nbsp;Nobuko Tanaka,&nbsp;Ryuichi Senda,&nbsp;Ichiro Okubo,&nbsp;Shinji Watanabe,&nbsp;Hideki Hasegawa,&nbsp;Yoshihiro Kawaoka,&nbsp;Emi Takashita","doi":"10.1111/irv.13345","DOIUrl":"10.1111/irv.13345","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Influenza viruses can cause zoonotic infections that pose public health risks. Surveillance of influenza A and B viruses is conducted globally; however, information on influenza C and D viruses is limited. Longitudinal monitoring of influenza C virus in humans has been conducted in several countries, but there has been no long-term monitoring of influenza D virus in humans. The public health risks associated with the influenza D virus therefore remain unknown.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We established a duplex real-time RT-PCR to detect influenza C and D viruses and analyzed respiratory specimens collected from 2144 patients in Japan with respiratory diseases between January 2018 and March 2023. We isolated viruses and conducted hemagglutination inhibition tests to examine antigenicity and focus reduction assays to determine susceptibility to the cap-dependent endonuclease inhibitor baloxavir marboxil.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>We detected three influenza C viruses belonging to the C/Kanagawa- or C/Sao Paulo-lineages, which recently circulated globally. None of the specimens was positive for the influenza D virus. The C/Yokohama/1/2022 strain, isolated from the specimen with the highest viral RNA load and belonging to the C/Kanagawa-lineage, showed similar antigenicity to the reference C/Kanagawa-lineage strain and was susceptible to baloxavir.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Our duplex real-time RT-PCR is useful for the simultaneous detection of influenza C and D viruses from the same specimen. Adding the influenza D virus to the monitoring of the influenza C virus would help in assessing the public health risks posed by this virus.</p>\u0000 </section>\u0000 </div>","PeriodicalId":13544,"journal":{"name":"Influenza and Other Respiratory Viruses","volume":"18 6","pages":""},"PeriodicalIF":4.3,"publicationDate":"2024-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11196370/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141456530","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Late-Season Influenza Vaccine Effectiveness Against Medically Attended Outpatient Illness, United States, December 2022–April 2023 2022 年 12 月至 2023 年 4 月美国晚季流感疫苗对门诊就医疾病的有效性。
IF 4.3 4区 医学 Q1 INFECTIOUS DISEASES Pub Date : 2024-06-23 DOI: 10.1111/irv.13342
Jessie R. Chung, Philip Shirk, Manjusha Gaglani, Manohar B. Mutnal, Mary Patricia Nowalk, Krissy Moehling Geffel, Stacey L. House, Tara Curley, Karen J. Wernli, Erika L. Kiniry, Emily T. Martin, Ivana A. Vaughn, Vel Murugan, Efrem S. Lim, Elie Saade, Kiran Faryar, Olivia L. Williams, Emmanuel B. Walter, Ashley M. Price, John R. Barnes, Juliana DaSilva, Rebecca Kondor, Sascha Ellington, Brendan Flannery

Background

The 2022–23 US influenza season peaked early in fall 2022.

Methods

Late-season influenza vaccine effectiveness (VE) against outpatient, laboratory-confirmed influenza was calculated among participants of the US Influenza VE Network using a test-negative design.

Results

Of 2561 participants enrolled from December 12, 2022 to April 30, 2023, 91 laboratory-confirmed influenza cases primarily had A(H1N1)pdm09 (6B.1A.5a.2a.1) or A(H3N2) (3C.2a1b.2a.2b). Overall, VE was 30% (95% confidence interval −9%, 54%); low late-season activity precluded estimation for most subgroups.

Conclusions

2022–23 late-season outpatient influenza VE was not statistically significant. Genomic characterization may improve the identification of influenza viruses that circulate postinfluenza peak.

背景2022-23年美国流感季节在2022年秋季提前达到高峰:方法:采用阴性试验设计,在美国流感疫苗接种网络的参与者中计算了晚季流感疫苗对门诊病人、实验室确诊流感的有效性(VE):在2022年12月12日至2023年4月30日期间注册的2561名参与者中,有91例经实验室确诊的流感病例主要为甲型H1N1 pdm09(6B.1A.5a.2a.1)或甲型H3N2(3C.2a1b.2a.2b)。总体而言,VE 为 30%(95% 置信区间为 -9%,54%);由于晚季活动较少,无法对大多数亚群进行估计:2022-23年流感晚季门诊病人VE在统计学上并不显著。基因组特征描述可提高对流感高峰后流行的流感病毒的识别能力。
{"title":"Late-Season Influenza Vaccine Effectiveness Against Medically Attended Outpatient Illness, United States, December 2022–April 2023","authors":"Jessie R. Chung,&nbsp;Philip Shirk,&nbsp;Manjusha Gaglani,&nbsp;Manohar B. Mutnal,&nbsp;Mary Patricia Nowalk,&nbsp;Krissy Moehling Geffel,&nbsp;Stacey L. House,&nbsp;Tara Curley,&nbsp;Karen J. Wernli,&nbsp;Erika L. Kiniry,&nbsp;Emily T. Martin,&nbsp;Ivana A. Vaughn,&nbsp;Vel Murugan,&nbsp;Efrem S. Lim,&nbsp;Elie Saade,&nbsp;Kiran Faryar,&nbsp;Olivia L. Williams,&nbsp;Emmanuel B. Walter,&nbsp;Ashley M. Price,&nbsp;John R. Barnes,&nbsp;Juliana DaSilva,&nbsp;Rebecca Kondor,&nbsp;Sascha Ellington,&nbsp;Brendan Flannery","doi":"10.1111/irv.13342","DOIUrl":"10.1111/irv.13342","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>The 2022–23 US influenza season peaked early in fall 2022.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Late-season influenza vaccine effectiveness (VE) against outpatient, laboratory-confirmed influenza was calculated among participants of the US Influenza VE Network using a test-negative design.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Of 2561 participants enrolled from December 12, 2022 to April 30, 2023, 91 laboratory-confirmed influenza cases primarily had A(H1N1)pdm09 (6B.1A.5a.2a.1) or A(H3N2) (3C.2a1b.2a.2b). Overall, VE was 30% (95% confidence interval −9%, 54%); low late-season activity precluded estimation for most subgroups.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>2022–23 late-season outpatient influenza VE was not statistically significant. Genomic characterization may improve the identification of influenza viruses that circulate postinfluenza peak.</p>\u0000 </section>\u0000 </div>","PeriodicalId":13544,"journal":{"name":"Influenza and Other Respiratory Viruses","volume":"18 6","pages":""},"PeriodicalIF":4.3,"publicationDate":"2024-06-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11194453/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141456529","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Adverse Effects Related to Paediatric Influenza Vaccination and Its Influence on Vaccination Acceptability. The FLUTETRA Study: A Survey Conducted in the Region of Murcia, Spain 与儿童流感疫苗接种有关的不良反应及其对疫苗接种可接受性的影响。FLUTETRA 研究:在西班牙穆尔西亚地区开展的一项调查
IF 4.3 4区 医学 Q1 INFECTIOUS DISEASES Pub Date : 2024-06-21 DOI: 10.1111/irv.13331
Matilde Zornoza Moreno, Jaime Jesús Pérez Martín, María Cruz Gómez Moreno, María del Carmen Valcárcel Gómez, Marta Pérez Martínez, Francisca Isabel Tornel Miñarro

Background

During the 2022–23 season, three autonomous communities recommended influenza vaccination for all children between 6 and 59 months. The objective is to evaluate the adverse effects associated with the administered influenza vaccines in the Region of Murcia, as well as their influence on the recommendation of the same to acquaintances or repetition in future seasons.

Material and Methods

Cross-sectional descriptive study with an online questionnaire sent to the parents of vaccinated minors of 6–23 months of age receiving inactivated intramuscular vaccine (IIV) or 24–59 months of age receiving live-attenuated intranasal vaccine (LAIV).

Results

Among 4971 surveys received, the most common adverse effect for LAIV and IIV was runny nose (40.90%) and local pain (31.94%), respectively. Sixty percent of adverse effects lasted ≤ 1 day, and around 10% lasted ≥ 3 days. The interference of adverse effects with the minor's daily life was very infrequent (3.32%), as was the need for visiting the medical office (2.68%). Overall, 96.44% of parents would recommend influenza vaccination to friends and relatives after the experience. Only 3.56% would not recommend it, while 1.68% would not vaccinate their child against influenza again. The most frequently cited reason being adverse effects.

Conclusions

Our study shows the safety of influenza vaccines. Despite the low impact of adverse effects, they influence some parents in their intention to continue vaccinating or recommending it to acquaintances, which remarks the need to reinforce the information given to parents so that this fact does not influence decision-making.

背景 2022-23 年流感季节期间,三个自治区建议所有 6 至 59 个月的儿童接种流感疫苗。研究的目的是评估穆尔西亚地区接种流感疫苗的不良反应,以及这些不良反应对向熟人推荐接种流感疫苗或在未来季节重复接种流感疫苗的影响。 材料与方法 横向描述性研究,向 6-23 个月龄接种肌肉注射灭活疫苗(IIV)或 24-59 个月龄接种鼻内减毒活疫苗(LAIV)的未成年人的父母发送在线问卷。 结果 在收到的 4971 份调查中,LAIV 和 IIV 最常见的不良反应分别是流鼻涕(40.90%)和局部疼痛(31.94%)。60%的不良反应持续时间不超过 1 天,约 10%持续时间超过 3 天。不良反应对未成年人日常生活造成干扰的情况很少(3.32%),需要到医务室就诊的情况也很少(2.68%)。总体而言,96.44% 的家长在体验后会向亲友推荐流感疫苗接种。只有 3.56% 的家长不会推荐,1.68% 的家长不会再给孩子接种流感疫苗。最常见的原因是不良反应。 结论 我们的研究表明流感疫苗是安全的。尽管不良反应的影响较小,但它们影响了一些家长继续接种或向熟人推荐的意向,这说明有必要加强向家长提供的信息,以免这一事实影响决策。
{"title":"Adverse Effects Related to Paediatric Influenza Vaccination and Its Influence on Vaccination Acceptability. The FLUTETRA Study: A Survey Conducted in the Region of Murcia, Spain","authors":"Matilde Zornoza Moreno,&nbsp;Jaime Jesús Pérez Martín,&nbsp;María Cruz Gómez Moreno,&nbsp;María del Carmen Valcárcel Gómez,&nbsp;Marta Pérez Martínez,&nbsp;Francisca Isabel Tornel Miñarro","doi":"10.1111/irv.13331","DOIUrl":"https://doi.org/10.1111/irv.13331","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>During the 2022–23 season, three autonomous communities recommended influenza vaccination for all children between 6 and 59 months. The objective is to evaluate the adverse effects associated with the administered influenza vaccines in the Region of Murcia, as well as their influence on the recommendation of the same to acquaintances or repetition in future seasons.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Material and Methods</h3>\u0000 \u0000 <p>Cross-sectional descriptive study with an online questionnaire sent to the parents of vaccinated minors of 6–23 months of age receiving inactivated intramuscular vaccine (IIV) or 24–59 months of age receiving live-attenuated intranasal vaccine (LAIV).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Among 4971 surveys received, the most common adverse effect for LAIV and IIV was runny nose (40.90%) and local pain (31.94%), respectively. Sixty percent of adverse effects lasted ≤ 1 day, and around 10% lasted ≥ 3 days. The interference of adverse effects with the minor's daily life was very infrequent (3.32%), as was the need for visiting the medical office (2.68%). Overall, 96.44% of parents would recommend influenza vaccination to friends and relatives after the experience. Only 3.56% would not recommend it, while 1.68% would not vaccinate their child against influenza again. The most frequently cited reason being adverse effects.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Our study shows the safety of influenza vaccines. Despite the low impact of adverse effects, they influence some parents in their intention to continue vaccinating or recommending it to acquaintances, which remarks the need to reinforce the information given to parents so that this fact does not influence decision-making.</p>\u0000 </section>\u0000 </div>","PeriodicalId":13544,"journal":{"name":"Influenza and Other Respiratory Viruses","volume":"18 6","pages":""},"PeriodicalIF":4.3,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/irv.13331","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141439637","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Association of Symptoms and Viral Culture Positivity for SARS-CoV-2—Tennessee, April–July 2020 田纳西州 2020 年 4 月至 7 月 SARS-CoV-2 症状与病毒培养阳性率的关系
IF 4.3 4区 医学 Q1 INFECTIOUS DISEASES Pub Date : 2024-06-21 DOI: 10.1111/irv.13318
Jessica E. Biddle, Gaston Bonenfant, Carlos G. Grijalva, Yuwei Zhu, Natasha B. Halasa, James D. Chappell, Alexandra Mellis, Carrie Reed, H. Keipp Talbot, Bin Zhou, Melissa A. Rolfes

Background

Understanding how symptoms are associated with SARS-CoV-2 culture positivity is important for isolation and transmission control guidelines.

Methods

Individuals acutely infected with SARS-CoV-2 in Tennessee and their household contacts were recruited into a prospective study. All participants self-collected nasal swabs daily for 14 days and completed symptom diaries from the day of illness onset through day 14 postenrollment. Nasal specimens were tested for SARS-CoV-2 using RT-qPCR. Positive specimens with cycle threshold values < 40 were sent to the Centers for Disease Control and Prevention (CDC) for viral culture. First, we modeled the association between symptoms and the risk of culture positivity using an age-adjusted generalized additive model (GAM) accounting for repeated measurements within participants and a symptom-day spline. Next, we investigated how timing of symptom resolution was associated with the timing of culture resolution.

Results

In a GAM restricted to follow-up days after symptoms began, the odds of a specimen being culture positive was significantly increased on days when wheezing, loss of taste or smell, runny nose, nasal congestion, sore throat, fever, or any symptom were reported. For all symptoms except sore throat, it was more common for participants to have culture resolution before symptom resolution than for culture to resolve after or on the same day as symptom resolution.

Conclusions

Overall, symptomatic individuals were more likely to be SARS-CoV-2 viral culture positive. For most symptoms, culture positivity was more likely to end before symptoms resolved. However, a proportion of individuals remained culture positive after symptom resolved, across all symptoms.

背景 了解症状与 SARS-CoV-2 培养阳性之间的关系对于制定隔离和传播控制指南非常重要。 方法 在田纳西州招募 SARS-CoV-2 急性感染者及其家庭接触者参与一项前瞻性研究。所有参与者在 14 天内每天自行采集鼻拭子,并填写从发病当天到加入后第 14 天的症状日记。使用 RT-qPCR 对鼻腔标本进行 SARS-CoV-2 检测。周期阈值为 40 的阳性标本被送往美国疾病控制和预防中心(CDC)进行病毒培养。首先,我们使用年龄调整后的广义加法模型(GAM)对症状与培养阳性风险之间的关系进行了建模,该模型考虑了参与者内部的重复测量和症状日曲线。接下来,我们研究了症状缓解的时间与培养缓解的时间之间的关系。 结果 在仅限于症状开始后随访天数的 GAM 中,当出现喘息、味觉或嗅觉丧失、流鼻涕、鼻塞、咽痛、发烧或任何症状时,标本培养呈阳性的几率会显著增加。对于除咽喉痛以外的所有症状,参与者在症状缓解前培养结果呈阳性的情况比症状缓解后或症状缓解当天培养结果呈阳性的情况更为常见。 结论 总体而言,有症状的人更有可能出现 SARS-CoV-2 病毒培养阳性。就大多数症状而言,培养阳性更有可能在症状缓解前结束。然而,在所有症状中,有一部分人在症状缓解后病毒培养仍呈阳性。
{"title":"Association of Symptoms and Viral Culture Positivity for SARS-CoV-2—Tennessee, April–July 2020","authors":"Jessica E. Biddle,&nbsp;Gaston Bonenfant,&nbsp;Carlos G. Grijalva,&nbsp;Yuwei Zhu,&nbsp;Natasha B. Halasa,&nbsp;James D. Chappell,&nbsp;Alexandra Mellis,&nbsp;Carrie Reed,&nbsp;H. Keipp Talbot,&nbsp;Bin Zhou,&nbsp;Melissa A. Rolfes","doi":"10.1111/irv.13318","DOIUrl":"https://doi.org/10.1111/irv.13318","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Understanding how symptoms are associated with SARS-CoV-2 culture positivity is important for isolation and transmission control guidelines.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Individuals acutely infected with SARS-CoV-2 in Tennessee and their household contacts were recruited into a prospective study. All participants self-collected nasal swabs daily for 14 days and completed symptom diaries from the day of illness onset through day 14 postenrollment. Nasal specimens were tested for SARS-CoV-2 using RT-qPCR. Positive specimens with cycle threshold values &lt; 40 were sent to the Centers for Disease Control and Prevention (CDC) for viral culture. First, we modeled the association between symptoms and the risk of culture positivity using an age-adjusted generalized additive model (GAM) accounting for repeated measurements within participants and a symptom-day spline. Next, we investigated how timing of symptom resolution was associated with the timing of culture resolution.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>In a GAM restricted to follow-up days after symptoms began, the odds of a specimen being culture positive was significantly increased on days when wheezing, loss of taste or smell, runny nose, nasal congestion, sore throat, fever, or any symptom were reported. For all symptoms except sore throat, it was more common for participants to have culture resolution before symptom resolution than for culture to resolve after or on the same day as symptom resolution.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Overall, symptomatic individuals were more likely to be SARS-CoV-2 viral culture positive. For most symptoms, culture positivity was more likely to end before symptoms resolved. However, a proportion of individuals remained culture positive after symptom resolved, across all symptoms.</p>\u0000 </section>\u0000 </div>","PeriodicalId":13544,"journal":{"name":"Influenza and Other Respiratory Viruses","volume":"18 6","pages":""},"PeriodicalIF":4.3,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/irv.13318","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141439616","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Identification of Various Recombinants in a Patient Coinfected With the Different SARS-CoV-2 Variants 在一名合并感染不同 SARS-CoV-2 变体的患者体内鉴定各种重组体
IF 4.4 4区 医学 Q1 INFECTIOUS DISEASES Pub Date : 2024-06-18 DOI: 10.1111/irv.13340
Yusuke Sayama, Akie Sakagami, Michiko Okamoto, Masahiro Sakamoto, Hikari Koizumi, Yoko Kimura, Clyde Dapat, Mayuko Saito, Yuko Suzuki, Mie Sasaki, Naoko Sugawara, Hitoshi Oshitani

Background

Viral recombination that occurs by exchanging genetic materials between two viral genomes coinfecting the same host cells is associated with the emergence of new viruses with different virulence. Herein, we detected a patient coinfected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Delta and Omicron variants and identified various recombinants in the SARS-CoV-2 full-length spike gene using long-read and Sanger sequencing.

Methods

Samples from five patients in Japan with household transmission of coronavirus disease 2019 (COVID-19) were analyzed using molecular assays for detection and identification of SARS-CoV-2. Whole-genome sequencing was conducted using multiplex PCR with short-read sequencing.

Results

Among the five SARS-CoV-2-positive patients, the mutation-specific assay identified the Delta variant in three, the Omicron variant in one, and an undetermined in one. The undermined patient was identified as Delta using whole-genome sequencing, but samples showed a mixed population of Delta and Omicron variants. This patient was analyzed for viral quasispecies by long-read and Sanger sequencing using a full-length spike gene amplicon. In addition to the Delta and Omicron sequences, the viral quasispecies analysis identified nine different genetic recombinant sequences with various breakpoints between Delta and Omicron sequences. The nine detected recombinant sequences in the spike gene showed over 99% identity with viruses that were detected during the Delta and Omicron cocirculation period from the United States and Europe.

Conclusions

This study demonstrates that patients coinfected with different SARS-CoV-2 variants can generate various viral recombinants and that various recombinant viruses may be produced during the cocirculation of different variants.

背景:病毒重组是通过共同感染同一宿主细胞的两个病毒基因组之间交换遗传物质而发生的,它与具有不同毒力的新病毒的出现有关。在本文中,我们检测了一名同时感染严重急性呼吸系统综合征冠状病毒 2(SARS-CoV-2)Delta 和 Omicron 变体的患者,并使用长读取和 Sanger 测序方法确定了 SARS-CoV-2 全长尖峰基因中的各种重组子:方法:使用分子检测方法分析了日本 5 名冠状病毒病 2019(COVID-19)家庭传播患者的样本,以检测和鉴定 SARS-CoV-2。利用多重 PCR 和短线程测序技术进行了全基因组测序:结果:在 5 名 SARS-CoV-2 阳性患者中,变异特异性检测确定了 3 名患者的 Delta 变异,1 名患者的 Omicron 变异,1 名患者的变异未确定。通过全基因组测序,确定了一名病情不稳定的患者为德尔塔变异体,但样本显示德尔塔变异体和奥米克隆变异体混合存在。该患者使用全长尖峰基因扩增片段,通过长线程和桑格测序分析了病毒类群。除 Delta 和 Omicron 序列外,病毒类群分析还发现了九种不同的基因重组序列,其断点介于 Delta 和 Omicron 序列之间。在尖峰基因中检测到的 9 个重组序列与美国和欧洲在 Delta 和 Omicron 共循环期间检测到的病毒的同一性超过 99%:这项研究表明,合并感染不同 SARS-CoV-2 变体的患者可产生各种病毒重组体,而且在不同变体的共循环期间也可能产生各种重组病毒。
{"title":"Identification of Various Recombinants in a Patient Coinfected With the Different SARS-CoV-2 Variants","authors":"Yusuke Sayama,&nbsp;Akie Sakagami,&nbsp;Michiko Okamoto,&nbsp;Masahiro Sakamoto,&nbsp;Hikari Koizumi,&nbsp;Yoko Kimura,&nbsp;Clyde Dapat,&nbsp;Mayuko Saito,&nbsp;Yuko Suzuki,&nbsp;Mie Sasaki,&nbsp;Naoko Sugawara,&nbsp;Hitoshi Oshitani","doi":"10.1111/irv.13340","DOIUrl":"10.1111/irv.13340","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Viral recombination that occurs by exchanging genetic materials between two viral genomes coinfecting the same host cells is associated with the emergence of new viruses with different virulence. Herein, we detected a patient coinfected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Delta and Omicron variants and identified various recombinants in the SARS-CoV-2 full-length spike gene using long-read and Sanger sequencing.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Samples from five patients in Japan with household transmission of coronavirus disease 2019 (COVID-19) were analyzed using molecular assays for detection and identification of SARS-CoV-2. Whole-genome sequencing was conducted using multiplex PCR with short-read sequencing.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Among the five SARS-CoV-2-positive patients, the mutation-specific assay identified the Delta variant in three, the Omicron variant in one, and an undetermined in one. The undermined patient was identified as Delta using whole-genome sequencing, but samples showed a mixed population of Delta and Omicron variants. This patient was analyzed for viral quasispecies by long-read and Sanger sequencing using a full-length spike gene amplicon. In addition to the Delta and Omicron sequences, the viral quasispecies analysis identified nine different genetic recombinant sequences with various breakpoints between Delta and Omicron sequences. The nine detected recombinant sequences in the spike gene showed over 99% identity with viruses that were detected during the Delta and Omicron cocirculation period from the United States and Europe.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>This study demonstrates that patients coinfected with different SARS-CoV-2 variants can generate various viral recombinants and that various recombinant viruses may be produced during the cocirculation of different variants.</p>\u0000 </section>\u0000 </div>","PeriodicalId":13544,"journal":{"name":"Influenza and Other Respiratory Viruses","volume":"18 6","pages":""},"PeriodicalIF":4.4,"publicationDate":"2024-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/irv.13340","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141418784","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Impact of SARS-CoV-2 Pandemic on Emergency Hospitalizations for Acute Respiratory Infections: The Experience of a Paediatric Tertiary Care Hospital in Italy SARS-CoV-2 大流行对急性呼吸道感染急诊住院的影响:意大利一家儿科三级医院的经验。
IF 4.4 4区 医学 Q1 INFECTIOUS DISEASES Pub Date : 2024-06-18 DOI: 10.1111/irv.13335
Marta Luisa Ciofi degli Atti, Flavia Beccia, Carmen D'Amore, Lucilla Ravà, Paola Bernaschi, Cristina Russo, Alberto Villani, Carlo Federico Perno, Massimiliano Raponi

Background

Acute respiratory infections (ARIs) are a major healthcare issue in children. The SARS-CoV-2 pandemic changed the epidemiology of ARIs; the aims of this study are to characterize the epidemiological trend of ARI emergency hospitalizations and virology results and to estimate the association of ARI emergency hospitalizations with respiratory viruses from January 2018 to June 2023.

Methods

This study was carried out in an Italian tertiary care children's hospital (Bambino Gesù Children's Hospital). The demographic and clinical information of children who accessed the Emergency Department (ED) with ARI and were hospitalized were retrospectively extracted from the electronic health records. Multivariate linear regression model was used to compare the number of ARI hospital admissions with the reported temporal trends in viruses diagnosed from respiratory samples throughout the same time period.

Results

During the study period, there were 92,140 ED visits and 10,541 hospitalizations due to ARIs, reflecting an admission rate of 11.4%. The highest proportion of hospitalizations occurred in infants ≤ 1 year of age (n = 4840, 45.9% of total admissions), with a hospitalization rate of 22.6%. Emergency hospitalizations aligned closely with the predictions made by the multivariate regression model; peaks in hospitalizations reflected Respiratory Syncytial Virus (RSV) circulation.

Conclusions

ARI hospital urgent admissions are a relevant component of ARI disease burden in children. RSV prevention and control are crucial to limit the risk of urgent hospitalizations due to ARIs.

背景:急性呼吸道感染(ARI)是儿童医疗保健的一个主要问题。SARS-CoV-2 大流行改变了急性呼吸道感染的流行病学;本研究旨在描述急性呼吸道感染急诊住院患者的流行病学趋势和病毒学结果,并估计 2018 年 1 月至 2023 年 6 月期间急性呼吸道感染急诊住院患者与呼吸道病毒的关联:本研究在意大利一家三级儿童医院(Bambino Gesù儿童医院)进行。研究人员从电子病历中回顾性地提取了因急性呼吸道感染就诊于急诊科(ED)并住院治疗的儿童的人口统计学和临床信息。研究采用多变量线性回归模型,将急性呼吸道感染入院人数与同期呼吸道样本中确诊病毒的时间趋势进行比较:在研究期间,因急性呼吸道感染到急诊室就诊的人数为 92140 人次,住院人数为 10541 人次,住院率为 11.4%。住院人数最多的是 1 岁以下的婴儿(4840 人,占住院总人数的 45.9%),住院率为 22.6%。急诊住院人数与多元回归模型的预测结果非常吻合;住院人数的高峰反映了呼吸道合胞病毒(RSV)的传播:结论:急性呼吸道感染紧急入院是儿童急性呼吸道感染疾病负担的重要组成部分。预防和控制 RSV 对限制急性呼吸道感染导致的紧急住院风险至关重要。
{"title":"Impact of SARS-CoV-2 Pandemic on Emergency Hospitalizations for Acute Respiratory Infections: The Experience of a Paediatric Tertiary Care Hospital in Italy","authors":"Marta Luisa Ciofi degli Atti,&nbsp;Flavia Beccia,&nbsp;Carmen D'Amore,&nbsp;Lucilla Ravà,&nbsp;Paola Bernaschi,&nbsp;Cristina Russo,&nbsp;Alberto Villani,&nbsp;Carlo Federico Perno,&nbsp;Massimiliano Raponi","doi":"10.1111/irv.13335","DOIUrl":"10.1111/irv.13335","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Acute respiratory infections (ARIs) are a major healthcare issue in children. The SARS-CoV-2 pandemic changed the epidemiology of ARIs; the aims of this study are to characterize the epidemiological trend of ARI emergency hospitalizations and virology results and to estimate the association of ARI emergency hospitalizations with respiratory viruses from January 2018 to June 2023.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>This study was carried out in an Italian tertiary care children's hospital (Bambino Gesù Children's Hospital). The demographic and clinical information of children who accessed the Emergency Department (ED) with ARI and were hospitalized were retrospectively extracted from the electronic health records. Multivariate linear regression model was used to compare the number of ARI hospital admissions with the reported temporal trends in viruses diagnosed from respiratory samples throughout the same time period.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>During the study period, there were 92,140 ED visits and 10,541 hospitalizations due to ARIs, reflecting an admission rate of 11.4%. The highest proportion of hospitalizations occurred in infants ≤ 1 year of age (<i>n</i> = 4840, 45.9% of total admissions), with a hospitalization rate of 22.6%. Emergency hospitalizations aligned closely with the predictions made by the multivariate regression model; peaks in hospitalizations reflected Respiratory Syncytial Virus (RSV) circulation.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>ARI hospital urgent admissions are a relevant component of ARI disease burden in children. RSV prevention and control are crucial to limit the risk of urgent hospitalizations due to ARIs.</p>\u0000 </section>\u0000 </div>","PeriodicalId":13544,"journal":{"name":"Influenza and Other Respiratory Viruses","volume":"18 6","pages":""},"PeriodicalIF":4.4,"publicationDate":"2024-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/irv.13335","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141418785","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Efficacy and Safety of Ensitrelvir for Asymptomatic or Mild COVID-19: An Exploratory Analysis of a Multicenter, Randomized, Phase 2b/3 Clinical Trial Ensitrelvir 治疗无症状或轻度 COVID-19 的有效性和安全性:一项多中心、随机、2b/3 期临床试验的探索性分析。
IF 4.4 4区 医学 Q1 INFECTIOUS DISEASES Pub Date : 2024-06-18 DOI: 10.1111/irv.13338
Norio Ohmagari, Hiroshi Yotsuyanagi, Yohei Doi, Masaya Yamato, Takumi Imamura, Hiroki Sakaguchi, Hideki Yamanaka, Ryosuke Imaoka, Akimasa Fukushi, Genki Ichihashi, Takao Sanaki, Yuko Tsuge, Takeki Uehara, Hiroshi Mukae

Background

This phase 2b/3, randomized, placebo-controlled trial explored the efficacy and evaluated the safety of ensitrelvir. This trial involved individuals with asymptomatic infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and patients with mild symptoms of coronavirus disease 2019 (COVID-19).

Methods

The trial was conducted at 57 medical institutions in Japan, South Korea, and Vietnam (study period: January 6–August 14, 2022). Eligible participants were randomized (1:1:1) to the ensitrelvir 125-mg, ensitrelvir 250-mg, or placebo group, received the allocated intervention orally, and were followed up until Day 28. Participants self-rated the severity of 14 typical COVID-19 symptoms and recorded the data in an electronic diary.

Results

In total, 572 participants (194, 189, and 189 in the ensitrelvir 125-mg, ensitrelvir 250-mg, and placebo groups, respectively) were included in the intention-to-treat population. Ensitrelvir 125-mg group observed a 77% reduction in the risk of developing any of the 14 COVID-19 symptoms or fever and a 29% reduction in the risk of worsening of such symptoms or fever versus placebo (statistically nonsignificant). The viral RNA, viral titer, and time to infectious viral clearance observed a statistically significant decrease versus placebo. Most treatment-related adverse events (TEAEs) were mild to moderate in severity, and the most common TEAE observed across groups was a decrease in high-density lipoprotein.

Conclusions

Our exploratory results suggest a potential reduction in the risk of development or worsening of COVID-19 symptoms with ensitrelvir. Ensitrelvir showed antiviral efficacy and was well tolerated.

Trial Registration: Japan Registry of Clinical Trials identifier: jRCT2031210350.

研究背景这项2b/3期随机安慰剂对照试验探讨了ensitrelvir的疗效并评估了其安全性。该试验涉及无症状感染严重急性呼吸系统综合征冠状病毒2(SARS-CoV-2)的患者和有轻微症状的2019年冠状病毒病(COVID-19)患者:试验在日本、韩国和越南的57家医疗机构进行(研究时间:2022年1月6日至8月14日)。符合条件的参与者被随机(1:1:1)分配到安斯瑞韦 125 毫克组、安斯瑞韦 250 毫克组或安慰剂组,口服所分配的干预药物,并随访至第 28 天。参与者对 14 种典型 COVID-19 症状的严重程度进行自我评分,并将数据记录在电子日记中:共有 572 名参与者(恩西替雷韦 125 毫克组、恩西替雷韦 250 毫克组和安慰剂组分别有 194 人、189 人和 189 人)被纳入意向治疗人群。与安慰剂相比,恩西特雷韦 125 毫克组出现 14 种 COVID-19 症状中任何一种症状或发热的风险降低了 77%,此类症状或发热恶化的风险降低了 29%(无统计学意义)。与安慰剂相比,病毒 RNA、病毒滴度和感染性病毒清除时间均出现统计学意义上的显著下降。大多数治疗相关不良事件(TEAEs)的严重程度为轻度至中度,各组中最常见的TEAE是高密度脂蛋白下降:我们的探索性研究结果表明,使用恩西雷韦可能会降低COVID-19症状发生或恶化的风险。恩西特韦具有抗病毒疗效,且耐受性良好:日本临床试验登记处标识符:jRCT2031210350。
{"title":"Efficacy and Safety of Ensitrelvir for Asymptomatic or Mild COVID-19: An Exploratory Analysis of a Multicenter, Randomized, Phase 2b/3 Clinical Trial","authors":"Norio Ohmagari,&nbsp;Hiroshi Yotsuyanagi,&nbsp;Yohei Doi,&nbsp;Masaya Yamato,&nbsp;Takumi Imamura,&nbsp;Hiroki Sakaguchi,&nbsp;Hideki Yamanaka,&nbsp;Ryosuke Imaoka,&nbsp;Akimasa Fukushi,&nbsp;Genki Ichihashi,&nbsp;Takao Sanaki,&nbsp;Yuko Tsuge,&nbsp;Takeki Uehara,&nbsp;Hiroshi Mukae","doi":"10.1111/irv.13338","DOIUrl":"10.1111/irv.13338","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>This phase 2b/3, randomized, placebo-controlled trial explored the efficacy and evaluated the safety of ensitrelvir. This trial involved individuals with asymptomatic infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and patients with mild symptoms of coronavirus disease 2019 (COVID-19).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>The trial was conducted at 57 medical institutions in Japan, South Korea, and Vietnam (study period: January 6–August 14, 2022). Eligible participants were randomized (1:1:1) to the ensitrelvir 125-mg, ensitrelvir 250-mg, or placebo group, received the allocated intervention orally, and were followed up until Day 28. Participants self-rated the severity of 14 typical COVID-19 symptoms and recorded the data in an electronic diary.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>In total, 572 participants (194, 189, and 189 in the ensitrelvir 125-mg, ensitrelvir 250-mg, and placebo groups, respectively) were included in the intention-to-treat population. Ensitrelvir 125-mg group observed a 77% reduction in the risk of developing any of the 14 COVID-19 symptoms or fever and a 29% reduction in the risk of worsening of such symptoms or fever versus placebo (statistically nonsignificant). The viral RNA, viral titer, and time to infectious viral clearance observed a statistically significant decrease versus placebo. Most treatment-related adverse events (TEAEs) were mild to moderate in severity, and the most common TEAE observed across groups was a decrease in high-density lipoprotein.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Our exploratory results suggest a potential reduction in the risk of development or worsening of COVID-19 symptoms with ensitrelvir. Ensitrelvir showed antiviral efficacy and was well tolerated.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <p><b>Trial Registration:</b> Japan Registry of Clinical Trials identifier: jRCT2031210350.</p>\u0000 </section>\u0000 </div>","PeriodicalId":13544,"journal":{"name":"Influenza and Other Respiratory Viruses","volume":"18 6","pages":""},"PeriodicalIF":4.4,"publicationDate":"2024-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/irv.13338","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141418783","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Single Vaccination of Ad26.RSV.preF-Based Regimen in Japanese Adults Aged 60 Years and Older 一项随机、双盲、安慰剂对照的 1 期研究,旨在评估基于 Ad26.RSV.preF 方案的单次疫苗接种对 60 岁及以上日本成人的安全性、致反应性和免疫原性。
IF 4.4 4区 医学 Q1 INFECTIOUS DISEASES Pub Date : 2024-06-16 DOI: 10.1111/irv.13336
Takashi Eto, Yusuke Okubo, Atsushi Momose, Hiroshi Tamura, Richuan Zheng, Benoit Callendret, Arangassery Rosemary Bastian, Christy A. Comeaux

Background

Respiratory syncytial virus (RSV) is increasingly recognized as a significant cause of lower respiratory tract disease (LRTD) in older adults. The Ad26.RSV.preF/RSV preF protein vaccine demonstrated protective efficacy against RSV related LRTD in a Phase 2b study in the United States. Hence, Ad26.RSV.preF/RSV preF protein vaccine candidate was evaluated in the Japanese older adult population.

Methods

This Phase 1 study evaluated safety, reactogenicity, and immunogenicity of Ad26.RSV.preF/RSV preF protein vaccine at dose level of 1 × 1011 vp/150 μg in Japanese healthy adult aged ≥60 years. The study included a screening Phase, vaccination, 28-day follow up Phase, a 182-day follow-up period, and final visit on Day 183. A total of 36 participants were randomized in a 2:1 ratio to receive Ad26.RSV.preF/RSV preF protein vaccine (n = 24) or placebo (n = 12). After study intervention administration, the safety and immunogenicity analysis were performed as per planned schedule. Immune responses including virus-neutralizing and preF-specific binding antibodies were measured on Days 1, 15, 29, and 183.

Results

There were no deaths, SAEs, or AEs leading to discontinuation reported during the study. The Ad26.RSV.preF/RSV preF protein vaccine had acceptable safety and tolerability profile with no safety concern in Japanese older adults. The Ad26.RSV.preF/RSV preF protein vaccine induced RSV-specific humoral immunity, with increase in antibody titers on Days 15 and 29 compared with baseline which was well maintained until Day 183.

Conclusions

A single dose of Ad26.RSV.preF/RSV preF protein vaccine had an acceptable safety and tolerability profile and induced RSV-specific humoral immunity in Japanese healthy adults.

Trial Registration

NCT number: NCT04354480; Clinical Registry number: CR108768.

背景:呼吸道合胞病毒(RSV)越来越被认为是导致老年人下呼吸道疾病(LRTD)的重要原因。在美国进行的一项 2b 期研究中,Ad26.RSV.preF/RSV preF 蛋白疫苗证明了对 RSV 相关 LRTD 的保护效力。因此,Ad26.RSV.preF/RSV preF 蛋白候选疫苗在日本老年人群中进行了评估:这项 1 期研究评估了 Ad26.RSV.preF/RSV preF 蛋白疫苗的安全性、反应原性和免疫原性,疫苗剂量为 1 × 1011 vp/150 μg,接种对象为年龄≥60 岁的日本健康成年人。该研究包括筛选阶段、接种阶段、28 天的随访阶段、182 天的随访期以及第 183 天的最终访问。共有 36 名参与者按 2:1 的比例随机接种 Ad26.RSV.preF/RSV preF 蛋白疫苗(n = 24)或安慰剂(n = 12)。研究干预给药后,按计划进行安全性和免疫原性分析。在第 1、15、29 和 183 天测量免疫反应,包括病毒中和抗体和前 F 特异性结合抗体:结果:研究期间没有死亡、SAE 或导致停药的 AE 报告。Ad26.RSV.preF/RSV preF蛋白疫苗在日本老年人中具有可接受的安全性和耐受性,没有安全问题。Ad26.RSV.preF/RSV preF蛋白疫苗可诱导RSV特异性体液免疫,第15天和第29天的抗体滴度与基线相比有所上升,并一直维持到第183天:单剂量 Ad26.RSV.preF/RSV preF 蛋白疫苗具有可接受的安全性和耐受性,可诱导日本健康成年人产生 RSV 特异性体液免疫:NCT 编号:NCT04354480试验注册:NCT04354480;临床注册编号:CR108768:CR108768。
{"title":"A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Single Vaccination of Ad26.RSV.preF-Based Regimen in Japanese Adults Aged 60 Years and Older","authors":"Takashi Eto,&nbsp;Yusuke Okubo,&nbsp;Atsushi Momose,&nbsp;Hiroshi Tamura,&nbsp;Richuan Zheng,&nbsp;Benoit Callendret,&nbsp;Arangassery Rosemary Bastian,&nbsp;Christy A. Comeaux","doi":"10.1111/irv.13336","DOIUrl":"10.1111/irv.13336","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Respiratory syncytial virus (RSV) is increasingly recognized as a significant cause of lower respiratory tract disease (LRTD) in older adults. The Ad26.RSV.preF/RSV preF protein vaccine demonstrated protective efficacy against RSV related LRTD in a Phase 2b study in the United States. Hence, Ad26.RSV.preF/RSV preF protein vaccine candidate was evaluated in the Japanese older adult population.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>This Phase 1 study evaluated safety, reactogenicity, and immunogenicity of Ad26.RSV.preF/RSV preF protein vaccine at dose level of 1 × 10<sup>11</sup> vp/150 μg in Japanese healthy adult aged ≥60 years. The study included a screening Phase, vaccination, 28-day follow up Phase, a 182-day follow-up period, and final visit on Day 183. A total of 36 participants were randomized in a 2:1 ratio to receive Ad26.RSV.preF/RSV preF protein vaccine (<i>n</i> = 24) or placebo (<i>n</i> = 12). After study intervention administration, the safety and immunogenicity analysis were performed as per planned schedule. Immune responses including virus-neutralizing and preF-specific binding antibodies were measured on Days 1, 15, 29, and 183.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>There were no deaths, SAEs, or AEs leading to discontinuation reported during the study. The Ad26.RSV.preF/RSV preF protein vaccine had acceptable safety and tolerability profile with no safety concern in Japanese older adults. The Ad26.RSV.preF/RSV preF protein vaccine induced RSV-specific humoral immunity, with increase in antibody titers on Days 15 and 29 compared with baseline which was well maintained until Day 183.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>A single dose of Ad26.RSV.preF/RSV preF protein vaccine had an acceptable safety and tolerability profile and induced RSV-specific humoral immunity in Japanese healthy adults.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Trial Registration</h3>\u0000 \u0000 <p>NCT number: NCT04354480; Clinical Registry number: CR108768.</p>\u0000 </section>\u0000 </div>","PeriodicalId":13544,"journal":{"name":"Influenza and Other Respiratory Viruses","volume":"18 6","pages":""},"PeriodicalIF":4.4,"publicationDate":"2024-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11180550/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141330865","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Clinical Outcomes of Coronavirus Disease 2019 in People Living With Human Immunodeficiency Virus in South Korea: A Nationwide Population-Based Cohort Study 韩国 2019 年人类免疫缺陷病毒感染者冠状病毒疾病的临床结果:基于全国人口的队列研究》(Nationalwide Population-Based Cohort Study)。
IF 4.4 4区 医学 Q1 INFECTIOUS DISEASES Pub Date : 2024-06-10 DOI: 10.1111/irv.13337
Jeong Yeon Kim, Yujin Jeong, Hyonggin An, Jin Woong Suh, Jang Wook Sohn, Young Kyung Yoon

Background

We aimed to compare the epidemiological and clinical characteristics of coronavirus disease 2019 (COVID-19) in people living with human immunodeficiency virus (HIV) (PLWH) with those in people living without HIV (PLWoH).

Methods

This nationwide descriptive epidemiological study was conducted in South Korea between January 2020 and February 2022. The National Health Insurance claim data, comprising the data of the entire Korean population, were collected through the Health Insurance Review and Assessment Service.

Results

Among 3,653,808 individuals who were diagnosed with COVID-19, 1311 (0.04%) were PLWH. All PLWH received antiretroviral therapy, and 26.47% had more than one underlying disease other than HIV infection. The overall in-hospital mortality rates of PLWH and PLWoH were 0.76% and 0.25%, respectively (P = 0.002). According to the Cox proportional hazard model, no significant difference was observed in the in-hospital mortality rate (hazard ratio [HR]: 1.80, 95% confidence interval [CI]: 0.70–4.67) between the PLWH and PLWoH. However, progression to severe or critical COVID-19 was more common in PLWH (HR: 2.70, 95% CI: 1.37–5.33). In PLWH diagnosed with COVID-19, a multivariable Cox regression analysis found old age (≥ 60 years) (HR: 6.9, 95% CI: 2.57–18.56) and diabetes mellitus (HR: 5.13, 95% CI: 2.02–13.00) as the independent risk factors for severe or critical COVID-19.

Conclusions

PLWH had a significantly higher risk of developing severe or critical COVID-19 compared with PLWoH. Our findings suggest the need for implementing tailored strategies to decrease the impact of COVID-19 on PLWH.

背景:我们旨在比较人类免疫缺陷病毒(HIV)感染者(PLWH)与非HIV感染者(PLWoH)中冠状病毒病2019(COVID-19)的流行病学和临床特征:这项全国性的描述性流行病学研究于 2020 年 1 月至 2022 年 2 月在韩国进行。通过健康保险审查和评估服务收集了国民健康保险索赔数据,其中包括韩国全体人口的数据:在 3,653,808 名确诊感染 COVID-19 的患者中,有 1311 人(0.04%)是 PLWH。所有 PLWH 都接受了抗逆转录病毒治疗,26.47% 的 PLWH 除感染 HIV 外还患有一种以上的基础疾病。PLWH 和 PLWoH 的总体院内死亡率分别为 0.76% 和 0.25%(P = 0.002)。根据 Cox 比例危险模型,PLWH 和 PLWoH 的院内死亡率无明显差异(危险比 [HR]:1.80,95% 置信区间 [CI]:0.70-4.67)。然而,在 PLWH 中,进展为严重或危重 COVID-19 的情况更为常见(HR:2.70,95% 置信区间 [CI]:1.37-5.33)。在确诊为 COVID-19 的 PLWH 中,多变量 Cox 回归分析发现,高龄(≥ 60 岁)(HR:6.9,95% CI:2.57-18.56)和糖尿病(HR:5.13,95% CI:2.02-13.00)是重度或危重 COVID-19 的独立风险因素:结论:与 PLWoH 相比,PLWH 感染严重或危重 COVID-19 的风险明显更高。我们的研究结果表明,有必要实施有针对性的策略来降低 COVID-19 对 PLWH 的影响。
{"title":"Clinical Outcomes of Coronavirus Disease 2019 in People Living With Human Immunodeficiency Virus in South Korea: A Nationwide Population-Based Cohort Study","authors":"Jeong Yeon Kim,&nbsp;Yujin Jeong,&nbsp;Hyonggin An,&nbsp;Jin Woong Suh,&nbsp;Jang Wook Sohn,&nbsp;Young Kyung Yoon","doi":"10.1111/irv.13337","DOIUrl":"10.1111/irv.13337","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>We aimed to compare the epidemiological and clinical characteristics of coronavirus disease 2019 (COVID-19) in people living with human immunodeficiency virus (HIV) (PLWH) with those in people living without HIV (PLWoH).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>This nationwide descriptive epidemiological study was conducted in South Korea between January 2020 and February 2022. The National Health Insurance claim data, comprising the data of the entire Korean population, were collected through the Health Insurance Review and Assessment Service.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Among 3,653,808 individuals who were diagnosed with COVID-19, 1311 (0.04%) were PLWH. All PLWH received antiretroviral therapy, and 26.47% had more than one underlying disease other than HIV infection. The overall in-hospital mortality rates of PLWH and PLWoH were 0.76% and 0.25%, respectively (<i>P</i> = 0.002). According to the Cox proportional hazard model, no significant difference was observed in the in-hospital mortality rate (hazard ratio [HR]: 1.80, 95% confidence interval [CI]: 0.70–4.67) between the PLWH and PLWoH. However, progression to severe or critical COVID-19 was more common in PLWH (HR: 2.70, 95% CI: 1.37–5.33). In PLWH diagnosed with COVID-19, a multivariable Cox regression analysis found old age (≥ 60 years) (HR: 6.9, 95% CI: 2.57–18.56) and diabetes mellitus (HR: 5.13, 95% CI: 2.02–13.00) as the independent risk factors for severe or critical COVID-19.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>PLWH had a significantly higher risk of developing severe or critical COVID-19 compared with PLWoH. Our findings suggest the need for implementing tailored strategies to decrease the impact of COVID-19 on PLWH.</p>\u0000 </section>\u0000 </div>","PeriodicalId":13544,"journal":{"name":"Influenza and Other Respiratory Viruses","volume":"18 6","pages":""},"PeriodicalIF":4.4,"publicationDate":"2024-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/irv.13337","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141300552","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
期刊
Influenza and Other Respiratory Viruses
全部 Acc. Chem. Res. ACS Applied Bio Materials ACS Appl. Electron. Mater. ACS Appl. Energy Mater. ACS Appl. Mater. Interfaces ACS Appl. Nano Mater. ACS Appl. Polym. Mater. ACS BIOMATER-SCI ENG ACS Catal. ACS Cent. Sci. ACS Chem. Biol. ACS Chemical Health & Safety ACS Chem. Neurosci. ACS Comb. Sci. ACS Earth Space Chem. ACS Energy Lett. ACS Infect. Dis. ACS Macro Lett. ACS Mater. Lett. ACS Med. Chem. Lett. ACS Nano ACS Omega ACS Photonics ACS Sens. ACS Sustainable Chem. Eng. ACS Synth. Biol. Anal. Chem. BIOCHEMISTRY-US Bioconjugate Chem. BIOMACROMOLECULES Chem. Res. Toxicol. Chem. Rev. Chem. Mater. CRYST GROWTH DES ENERG FUEL Environ. Sci. Technol. Environ. Sci. Technol. Lett. Eur. J. Inorg. Chem. IND ENG CHEM RES Inorg. Chem. J. Agric. Food. Chem. J. Chem. Eng. Data J. Chem. Educ. J. Chem. Inf. Model. J. Chem. Theory Comput. J. Med. Chem. J. Nat. Prod. J PROTEOME RES J. Am. Chem. Soc. LANGMUIR MACROMOLECULES Mol. Pharmaceutics Nano Lett. Org. Lett. ORG PROCESS RES DEV ORGANOMETALLICS J. Org. Chem. J. Phys. Chem. J. Phys. Chem. A J. Phys. Chem. B J. Phys. Chem. C J. Phys. Chem. Lett. Analyst Anal. Methods Biomater. Sci. Catal. Sci. Technol. Chem. Commun. Chem. Soc. Rev. CHEM EDUC RES PRACT CRYSTENGCOMM Dalton Trans. Energy Environ. Sci. ENVIRON SCI-NANO ENVIRON SCI-PROC IMP ENVIRON SCI-WAT RES Faraday Discuss. Food Funct. Green Chem. Inorg. Chem. Front. Integr. Biol. J. Anal. At. Spectrom. J. Mater. Chem. A J. Mater. Chem. B J. Mater. Chem. C Lab Chip Mater. Chem. Front. Mater. Horiz. MEDCHEMCOMM Metallomics Mol. Biosyst. Mol. Syst. Des. Eng. Nanoscale Nanoscale Horiz. Nat. Prod. Rep. New J. Chem. Org. Biomol. Chem. Org. Chem. Front. PHOTOCH PHOTOBIO SCI PCCP Polym. Chem.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1