Human Vaccines & Immunotherapeutics最新文献

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A phase 3 randomized, open-label study evaluating the immunogenicity and safety of concomitant and staggered administration of a live, pentavalent rotavirus vaccine and an inactivated poliomyelitis vaccine in healthy infants in China. 一项 3 期随机、开放标签研究,评估在中国健康婴儿中同时和交错接种五价轮状病毒活疫苗和脊髓灰质炎灭活疫苗的免疫原性和安全性。
IF 4.8 4区 医学
Human Vaccines & Immunotherapeutics Pub Date : 2024-12-31 Epub Date: 2024-03-20 DOI: 10.1080/21645515.2024.2324538
Shaomin Chen, Zhifang Ying, Yan Liu, Yuan Li, Yebin Yu, Meilian Huang, Zhuhang Huang, Zhiqiang Ou, Yuyi Liao, Yong Zhang, Guixiu Liu, Weiwei Zhao, Rong Fu, Qiong Shou, Minghuan Zheng, Xueyan Liao, Yingmei Tu, Jon Stek, Jonathan Hartzel, Changgui Li, Jikai Zhang
{"title":"A phase 3 randomized, open-label study evaluating the immunogenicity and safety of concomitant and staggered administration of a live, pentavalent rotavirus vaccine and an inactivated poliomyelitis vaccine in healthy infants in China.","authors":"Shaomin Chen, Zhifang Ying, Yan Liu, Yuan Li, Yebin Yu, Meilian Huang, Zhuhang Huang, Zhiqiang Ou, Yuyi Liao, Yong Zhang, Guixiu Liu, Weiwei Zhao, Rong Fu, Qiong Shou, Minghuan Zheng, Xueyan Liao, Yingmei Tu, Jon Stek, Jonathan Hartzel, Changgui Li, Jikai Zhang","doi":"10.1080/21645515.2024.2324538","DOIUrl":"10.1080/21645515.2024.2324538","url":null,"abstract":"<p><p>This open-label, randomized, phase 3 study in China (V260-074; NCT04481191) evaluated the immunogenicity and safety of concomitant and staggered administration of three doses of an oral, live, pentavalent rotavirus vaccine (RV5) and three doses of an intramuscular, inactivated poliomyelitis vaccine (IPV) in 400 healthy infants. The primary objective was the non-inferiority of neutralizing antibody (nAb) responses in the concomitant- versus the staggered-use groups. Antibody responses were measured at baseline and 1-month post-dose 3 (PD3). Parents/legal guardians recorded adverse events for 30 or 15 d after study vaccinations in the concomitant-use or staggered-use groups, respectively. At PD3, >98% of participants seroconverted to all three poliovirus types, and the primary objective was met as lower bounds of the two-sided 95% CI for between-group difference in nAb seroconversion percentages ranged from - 4.3% to - 1.6%, for all poliovirus types, <i>p</i> < .001. At PD3, geometric mean titers (GMTs) of nAb responses to poliovirus types 1, 2, and 3 in the concomitant-use group and the staggered-use group were comparable; 100% of participants had nAb titers ≥1:8 and ≥1:64 for all poliovirus types. Anti-rotavirus serotype-specific IgA GMTs and participants with ≥3-fold rise in postvaccination titers from baseline were comparable between groups. Administration of RV5 and IPV was well tolerated with comparable safety profiles in both groups. The immunogenicity of IPV in the concomitant-use group was non-inferior to the staggered-use group and RV5 was immunogenic in both groups. No safety concerns were identified. These data support the concomitant use of RV5 and IPV in healthy Chinese infants.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10962606/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140177309","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
The impact of risk perception and institutional trust on COVID-19 vaccine hesitancy in China. 风险认知和机构信任对中国 COVID-19 疫苗接种犹豫不决的影响。
IF 4.8 4区 医学
Human Vaccines & Immunotherapeutics Pub Date : 2024-12-31 Epub Date: 2024-01-28 DOI: 10.1080/21645515.2024.2301793
Guiwu Chen, Yiyun Yao, Yaowen Zhang, Fei Zhao
{"title":"The impact of risk perception and institutional trust on COVID-19 vaccine hesitancy in China.","authors":"Guiwu Chen, Yiyun Yao, Yaowen Zhang, Fei Zhao","doi":"10.1080/21645515.2024.2301793","DOIUrl":"10.1080/21645515.2024.2301793","url":null,"abstract":"<p><p>Vaccination has become the primary means for citizens to prevent severe morbidity and mortality during the pandemic. However, vaccine hesitancy poses a major threat to global public health security. Based on the data from Chinese General Social Survey in 2021, this study aims to explore the socio-political aspects of COVID-19 vaccine hesitancy, focusing on the relationship between COVID-19 risk perceptions, institutional trust and vaccine hesitancy. Among the samples, 39.8% of the respondents exhibited COVID-19 vaccine hesitancy, 48.9% had a high awareness of the risk of COVID-19, and 74.6% presented a high level of trust in institutions. The results showed that higher risk perception and institutional trust are negatively correlated with vaccine hesitancy (<i>p</i> < .001). Institutional trust had no statistically significant moderating effect on the association between risk perception and vaccine hesitancy, but the role of institutional trust in influencing vaccine hesitancy is more significant at a lower level of perceptions of COVID-19 risk. Furthermore, regional variations in the factors contributing to vaccine hesitancy were demonstrated in China. These findings have important implications for developing strategies to address vaccine hesitancy.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10826627/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139571658","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
Revamping the BCG revaccination strategy: Records to recall, or just call it phoenix? 改革卡介苗接种策略:记录召回,还是凤毛麟角?
IF 4.8 4区 医学
Human Vaccines & Immunotherapeutics Pub Date : 2024-12-31 Epub Date: 2024-01-29 DOI: 10.1080/21645515.2023.2300158
Paulo R Z Antas, Mario A Flores-Valdez, Camille Locht
{"title":"Revamping the BCG revaccination strategy: Records to recall, or just call it phoenix?","authors":"Paulo R Z Antas, Mario A Flores-Valdez, Camille Locht","doi":"10.1080/21645515.2023.2300158","DOIUrl":"10.1080/21645515.2023.2300158","url":null,"abstract":"","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10829833/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139576925","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
Safety and efficiency of COVID-19 vaccine in North Africa. COVID-19 疫苗在北非的安全性和有效性。
IF 4.8 4区 医学
Human Vaccines & Immunotherapeutics Pub Date : 2024-12-31 Epub Date: 2024-02-02 DOI: 10.1080/21645515.2024.2306703
Souhir Chelly, Shayma Jaziri, Asma Ammar, Olfa Ezzi, Nour Douss, Sonia Saffar, Marouen Tritar, Mansour Njah, Mohamed Mahjoub
{"title":"Safety and efficiency of COVID-19 vaccine in North Africa.","authors":"Souhir Chelly, Shayma Jaziri, Asma Ammar, Olfa Ezzi, Nour Douss, Sonia Saffar, Marouen Tritar, Mansour Njah, Mohamed Mahjoub","doi":"10.1080/21645515.2024.2306703","DOIUrl":"10.1080/21645515.2024.2306703","url":null,"abstract":"<p><p>Background In the absence of a specific treatment for COVID-19, preventive measures have been implemented to control this pandemic and vaccination is one of them. However, it is crucial to verify the safety and efficiency of every vaccine. The aim was to determinate the predictive factors of side effects and reinfection after COVID-19 vaccine. Methods A cross-sectional study was conducted in February 2022 among Tunisians infected with COVID-19 between March 2020 and February 2022, using an online self-administered questionnaire. We conducted univariate and multivariate analyses using binary stepwise logistic regression. Results A total of 1541 was selected from 1911 individuals. Comorbidities affected a quarter of the population (22.3%). Before the initial infection, 39.3% had received full vaccination, and 8.7% had received partial vaccination. By February 2022, the majority (82.9%) had received at least two vaccine doses. The reinfection rate was 30.6%. All vaccines prior to the first infection was identified as a protective factor against reinfection. Inactivated virus vaccinations were less likely to induce adverse effects. Conclusion ach vaccine has its own set of advantages and disadvantages: mRNA-based vaccines had a higher incidence of side effects but all vaccines provided better protection against reinfection.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10841012/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139673350","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
Real-world data of China: Analysis of HPV vaccine coverage and post-vaccination adverse reaction monitoring in Western Chinese provinces from 2018 to 2021. 中国的真实数据:2018-2021年中国西部省份HPV疫苗覆盖率及接种后不良反应监测分析。
IF 4.8 4区 医学
Human Vaccines & Immunotherapeutics Pub Date : 2024-12-31 Epub Date: 2024-02-19 DOI: 10.1080/21645515.2024.2315653
Jing An, Yan Liu, Yingchun Ma, Yong-Zhuo Jiao, Xue-Feng Liang, Na Jin, Junyi Bao, Nan Jiang, Xiao-Shu Zhang
{"title":"Real-world data of China: Analysis of HPV vaccine coverage and post-vaccination adverse reaction monitoring in Western Chinese provinces from 2018 to 2021.","authors":"Jing An, Yan Liu, Yingchun Ma, Yong-Zhuo Jiao, Xue-Feng Liang, Na Jin, Junyi Bao, Nan Jiang, Xiao-Shu Zhang","doi":"10.1080/21645515.2024.2315653","DOIUrl":"10.1080/21645515.2024.2315653","url":null,"abstract":"<p><p>To investigate the HPV vaccine coverage and post-vaccination adverse reactions in Gansu Province, Western China, from 2018 to 2021. Data on suspected adverse reactions to HPV vaccines were collected from the Chinese Vaccine Adverse Event Following Immunization (AEFI). Estimate the incidence rates of Common Adverse Reaction and Rare Adverse Reaction. HPV vaccine coverage among females in different age groups was calculated using data from the Gansu Provincial Immunization Information Platform. The first-dose HPV vaccine coverage rate among females aged 9 to 45 was 2.02%, with the lowest rate of less than 1% observed in females aged 9 to 14. From 2018 to 2021, the incidence rates of Common Adverse Reaction and Rare Adverse Reaction reported in females after HPV vaccination were 11.82 and 0.39 per 100,000 doses, respectively. Common Adverse Reaction included fever (5.52 per 100,000 doses), local redness and swelling (3.33 per 100,000 doses), fatigue (3.15 per 100,000 doses), headache (2.76 per 100,000 doses), as well as local induration and nausea/vomiting (1.97 per 100,000 doses). Adverse reactions mainly occurred within 1 day after vaccination, followed by 1 to 3 days after vaccination. The HPV vaccine coverage rate among females aged 9 to 14 in Gansu Province is remarkably low, and there is an urgent need to enhance vaccine coverage. From 2018 to 2021, the incidence of Adverse reaction Following Immunization HPV vaccination fell within the expected range, indicating the vaccine's safety profile.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10878016/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139900786","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
Sustainable financing for vaccination towards advancing universal health coverage in the WHO African region: The strategic role of national health insurance. 为疫苗接种提供可持续资金,以推进世卫组织非洲地区的全民医保:国家医疗保险的战略作用。
IF 4.8 4区 医学
Human Vaccines & Immunotherapeutics Pub Date : 2024-12-31 Epub Date: 2024-02-27 DOI: 10.1080/21645515.2024.2320505
Abdu A Adamu, Rabiu I Jalo, Ibrahim D Muhammad, Téné-Alima Essoh, Duduzile Ndwandwe, Charles S Wiysonge
{"title":"Sustainable financing for vaccination towards advancing universal health coverage in the WHO African region: The strategic role of national health insurance.","authors":"Abdu A Adamu, Rabiu I Jalo, Ibrahim D Muhammad, Téné-Alima Essoh, Duduzile Ndwandwe, Charles S Wiysonge","doi":"10.1080/21645515.2024.2320505","DOIUrl":"10.1080/21645515.2024.2320505","url":null,"abstract":"<p><p>There is a growing political interest in health reforms in Africa, and many countries are choosing national health insurance as their main financing mechanism for universal health coverage. Although vaccination is an essential health service that can influence progress toward universal health coverage, it is not often prioritized by these national health insurance systems. This paper highlights the potential gains of integrating vaccination into the package of health services that is provided through national health insurance and recommends practical policy actions that can enable countries to harness these benefits at population level.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10903629/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139984277","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
Banana-shaped survival curves of metastatic renal cell carcinoma treated with first-line immune-combinations, not just a matter of "palateau". 接受一线免疫组合治疗的转移性肾细胞癌的香蕉形生存曲线,不仅仅是 "宫颈癌 "的问题。
IF 4.8 4区 医学
Human Vaccines & Immunotherapeutics Pub Date : 2024-12-31 Epub Date: 2024-05-17 DOI: 10.1080/21645515.2024.2351669
Sara Elena Rebuzzi, Giuseppe Fornarini, Alessio Signori, Pasquale Rescigno, Giuseppe Luigi Banna, Sebastiano Buti
{"title":"Banana-shaped survival curves of metastatic renal cell carcinoma treated with first-line immune-combinations, not just a matter of \"palateau\".","authors":"Sara Elena Rebuzzi, Giuseppe Fornarini, Alessio Signori, Pasquale Rescigno, Giuseppe Luigi Banna, Sebastiano Buti","doi":"10.1080/21645515.2024.2351669","DOIUrl":"10.1080/21645515.2024.2351669","url":null,"abstract":"<p><p>The first-line therapy of metastatic renal cell carcinoma (mRCC) has revolutionized with the approval of immune checkpoint inhibitors (ICIs) in combination with or without tyrosine kinase inhibitors (TKIs). The choice among the many different immuno-combinations (ICI-ICI or ICI-TKI) is challenging due to the lack of predictive factors. The different shapes of the Kaplan-Meier survival curves (e.g. \"banana-shaped curves\") have raised many questions on the long-term survival benefit. Here, we analyzed the factors that could have impacted the different long-term survival, including the prognostic factors distribution (IMDC score), histological factors (sarcomatoid features, PD-L1 expression), and treatment characteristics (mechanism of action, duration, discontinuation rate). This overview highlights the factors that should be considered in the first-line setting for the patients' therapeutic choice and prognostic assessment. They are also fundamental parameters to examined for head-to-head studies and real-life, large-scale studies.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11110690/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140960494","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
Number of tetanus toxoid injections before birth and associated factors among pregnant women in low and middle income countries: Negative binomial poisson regression. 中低收入国家孕妇产前注射破伤风类毒素的次数及相关因素:负二项泊松回归。
IF 4.8 4区 医学
Human Vaccines & Immunotherapeutics Pub Date : 2024-12-31 Epub Date: 2024-05-21 DOI: 10.1080/21645515.2024.2352905
Alebachew Ferede Zegeye, Tadesse Tarik Tamir, Enyew Getaneh Mekonen, Mohammed Seid Ali, Almaz Tefera Gonete, Masresha Asmare Techane, Mulugeta Wassie, Alemneh Tadesse Kassie, Medina Abdela Ahmed, Sintayehu Simie Tsega, Yilkal Abebaw Wassie, Berhan Tekeba, Belayneh Shetie Workneh
{"title":"Number of tetanus toxoid injections before birth and associated factors among pregnant women in low and middle income countries: Negative binomial poisson regression.","authors":"Alebachew Ferede Zegeye, Tadesse Tarik Tamir, Enyew Getaneh Mekonen, Mohammed Seid Ali, Almaz Tefera Gonete, Masresha Asmare Techane, Mulugeta Wassie, Alemneh Tadesse Kassie, Medina Abdela Ahmed, Sintayehu Simie Tsega, Yilkal Abebaw Wassie, Berhan Tekeba, Belayneh Shetie Workneh","doi":"10.1080/21645515.2024.2352905","DOIUrl":"10.1080/21645515.2024.2352905","url":null,"abstract":"<p><strong>Background: </strong>In low- and middle-income countries where vaccination rates are low, tetanus is still an important threat to public health. Although maternal and neonatal tetanus remains a major global health concern, its magnitude and determinates are not well studied. Therefore, this study aimed to assess the number of tetanus toxoid injections and associated factors among pregnant women in low- and middle-income countries.</p><p><strong>Methods: </strong>Data from the most recent Demographic and Health Surveys, which covered 60 low- and middle-income countries from 2010 to 2022, was used for secondary data analysis. The study included a total of 118,704 pregnant women. A statistical software package, STATA 14, was used to analyze the data. A negative binomial regression of a cross-sectional study was carried out. Factors associated with the number of tetanus vaccinations were declared significant at a p-value of < 0.05. The incidence rate ratio and confidence interval were used to interpret the results. A model with the smallest Akaike Information Criterion and Bayesian Information Criterion values and the highest log likelihood was considered the best-fit model for this study.</p><p><strong>Results: </strong>In low- and middle-income countries, 26.0% of pregnant women took at least two doses of the tetanus toxoid vaccine. Factors such as maternal education, primary (IRR = 1.22, 95% CI: 1.17, 1.26), secondary (IRR = 1.19, 95% CI: 1.15, 1.23), higher (IRR = 1.16, 95% CI: 1.12, 1.20), employment (IRR = 1.11, 95% CI: 1.09, 1.13), 1-3 ANC visits (IRR = 2.49, 95% CI: 2.41, 2.57), ≥4 visits (IRR = 2.94, 95% CI: 2.84, 3.03), wealth index (IRR = 1.06; 95% CI: 11.04, 1.08), ≥birth order (IRR = 1.04, 95% CI: 1.02, 1.27), distance to health facility (IRR = 1.02, 95% CI: 1.00, 1.03), and health insurance coverage (IRR = 1.08; 95% CI: 1.06, 1.10) had a significant association with the number of tetanus vaccinations among pregnant women.</p><p><strong>Conclusions and recommendations: </strong>This study concludes that the number of tetanus toxoid vaccinations among pregnant women in low- and middle-income countries is low. In the negative binomial model, the frequency of tetanus vaccinations has a significant association with maternal employment, educational status, wealth index, antenatal care visits, birth order, distance from a health facility, and health insurance. Therefore, the ministries of health in low and middle-income countries should give attention to those women who had no antenatal care visits and women from poor wealth quantiles while designing policies and strategies.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11110706/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141077059","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
Polymyalgia rheumatica and giant cell arteritis following COVID-19 vaccination: Results from a nationwide survey. 接种 COVID-19 疫苗后的多发性风湿痛和巨细胞动脉炎:全国性调查的结果。
IF 4.8 4区 医学
Human Vaccines & Immunotherapeutics Pub Date : 2024-12-31 Epub Date: 2024-04-02 DOI: 10.1080/21645515.2024.2334084
Pierre-André Jarrot, Adrien Mirouse, Sébastien Ottaviani, Simon Cadiou, Jean-Hugues Salmon, Eric Liozon, Simon Parreau, Martin Michaud, Benjamin Terrier, Pierre-Edouard Gavand, Ludovic Trefond, Virginie Lavoiepierre, Jeremy Keraen, Daniel Rekassa, Bastien Bouldoires, Thierry Weitten, Damien Roche, Antoine Poulet, Caroline Charpin, Vincent Grobost, Marion Hermet, Magali Pallure, Chloe Wackenheim, Ludovic Karkowski, Pierre Grumet, Thomas Rogier, Nabil Belkefi, Vincent Pestre, Emilie Broquet, Amélie Leurs, Sophie Gautier, Valérie Gras, Pierre Gilet, Jan Holubar, Nadia Sivova, Nicolas Schleinitz, Jean-Marc Durand, Brice Castel, Alexandre Petrier, Robin Arcani, Baptiste Gramont, Philippe Guilpain, Hubert Lepidi, Pierre-Jean Weiller, Joelle Micallef, David Saadoun, Gilles Kaplanski
{"title":"Polymyalgia rheumatica and giant cell arteritis following COVID-19 vaccination: Results from a nationwide survey.","authors":"Pierre-André Jarrot, Adrien Mirouse, Sébastien Ottaviani, Simon Cadiou, Jean-Hugues Salmon, Eric Liozon, Simon Parreau, Martin Michaud, Benjamin Terrier, Pierre-Edouard Gavand, Ludovic Trefond, Virginie Lavoiepierre, Jeremy Keraen, Daniel Rekassa, Bastien Bouldoires, Thierry Weitten, Damien Roche, Antoine Poulet, Caroline Charpin, Vincent Grobost, Marion Hermet, Magali Pallure, Chloe Wackenheim, Ludovic Karkowski, Pierre Grumet, Thomas Rogier, Nabil Belkefi, Vincent Pestre, Emilie Broquet, Amélie Leurs, Sophie Gautier, Valérie Gras, Pierre Gilet, Jan Holubar, Nadia Sivova, Nicolas Schleinitz, Jean-Marc Durand, Brice Castel, Alexandre Petrier, Robin Arcani, Baptiste Gramont, Philippe Guilpain, Hubert Lepidi, Pierre-Jean Weiller, Joelle Micallef, David Saadoun, Gilles Kaplanski","doi":"10.1080/21645515.2024.2334084","DOIUrl":"10.1080/21645515.2024.2334084","url":null,"abstract":"<p><p>We conducted a national in-depth analysis including pharmacovigilance reports and clinical study to assess the reporting rate (RR) and to determine the clinical profile of polymyalgia rheumatica (PMR) and giant cell arteritis (GCA) in COVID-19-vaccinated individuals. First, based on the French pharmacovigilance database, we estimated the RR of PMR and GCA cases in individuals aged over 50 who developed their initial symptoms within one month of receiving the BNT162b2 mRNA, mRNA-1273, ChAdOx1 nCoV-19, and Ad26.COV2.S vaccines. We then conducted a nationwide survey to gather clinical profiles, therapeutic management, and follow-up data from individuals registered in the pharmacovigilance study. A total of 70 854 684 COVID-19 vaccine doses were administered to 25 260 485 adults, among which, 179 cases of PMR (RR 7. 1 cases/1 000 000 persons) and 54 cases of GCA (RR 2. 1 cases/1 000 000 persons) have been reported. The nationwide survey allowed the characterization of 60 PMR and 35 GCA cases. Median time to the onset of first symptoms was 10 (range 2-30) and 7 (range 2-25) days for PMR and GCA, respectively. Phenotype, GCA-related ischemic complications and -large vessel vasculitis as well as therapeutic management and follow-up seemed similar according to the number of vaccine shots received and when compared to the literature data of unvaccinated population. Although rare, the short time between immunization and the onset of first symptoms of PMR and GCA suggests a temporal association. Physician should be aware of this potential vaccine-related phenomenon.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10989707/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140337418","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
Driving consistency: CEPI-Centralized Laboratory Network's conversion factor initiative for SARS-CoV-2 clinical assays used for efficacy assessment of COVID vaccines. 推动一致性:CEPI - 集中实验室网络用于 COVID 疫苗有效性评估的 SARS-CoV-2 临床检测转换系数倡议。
IF 4.8 4区 医学
Human Vaccines & Immunotherapeutics Pub Date : 2024-12-31 Epub Date: 2024-05-06 DOI: 10.1080/21645515.2024.2344249
Ali Azizi, Gathoni Kamuyu, Deborah Ogbeni, Philipa Levesque-Damphousse, Daniel Knott, Luc Gagnon, Steven Phay-Tran, Bethan Hussey, Pamela Proud, Sue Charlton, Carolyn Clark, Valentina Bernasconi
{"title":"Driving consistency: CEPI-Centralized Laboratory Network's conversion factor initiative for SARS-CoV-2 clinical assays used for efficacy assessment of COVID vaccines.","authors":"Ali Azizi, Gathoni Kamuyu, Deborah Ogbeni, Philipa Levesque-Damphousse, Daniel Knott, Luc Gagnon, Steven Phay-Tran, Bethan Hussey, Pamela Proud, Sue Charlton, Carolyn Clark, Valentina Bernasconi","doi":"10.1080/21645515.2024.2344249","DOIUrl":"10.1080/21645515.2024.2344249","url":null,"abstract":"<p><p>To date, thousands of SARS-CoV-2 samples from many vaccine developers have been tested within the CEPI-Centralized Laboratory Network. To convert data from each clinical assay to international standard units, the WHO international standard and the CEPI standard generated by the Medicines and Healthcare products Regulatory Agency were run in multiple facilities to determine the conversion factor for each assay. Reporting results in international units advances global understanding of SARS-CoV-2 immunity and vaccine efficacy, enhancing the quality, reliability, and utility of clinical assay data.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11085944/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140861050","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
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