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Comparable and sustained levels of S1-RBD-IgG and S1-RBD-IgA in BNT162b2 homologous and CoronaVac-BNT162b2 heterologous booster vaccination: A 22-month prospective study in Malaysia. BNT162b2同源和CoronaVac-BNT162b2异源加强免疫中S1-RBD-IgG和S1-RBD-IgA水平的可比性和持续性:在马来西亚进行的一项为期 22 个月的前瞻性研究。
Pub Date : 2024-12-02 Epub Date: 2024-10-28 DOI: 10.1016/j.vaccine.2024.126471
Anis Atifah Mohd Hisham, Aini Syahida Mat Yassim, Rapeah Suppian, Maryam Azlan, Amiratul Aifa Mohamad Asri, Nur Suhaila Idris, Rosediani Muhamad, Mohd Nor Norazmi

This prospective cohort study examines the long-term humoral immune responses post-COVID-19 vaccination in 146 individuals who received either a homologous three-dose BNT162b2 vaccine regimen (PPP) or two primary doses of CoronaVac followed by BNT162b2 booster (SSP) in Malaysia. The study focuses on serum anti-S1-RBD-IgG, -IgA, and -IgM, using the ELISA method. The results show that BNT162b2 outperformed CoronaVac in the two dose primary vaccination series. BNT162b2 booster dose significantly raised serum anti-S1-RBD-IgG and -IgA levels, sustaining this increase from 26 to 52 weeks after administration, regardless of the vaccine regimen. This leads to equivalent levels of anti-S1-RBD-IgG and -IgA after boosting with BNT162b2 in both groups. Breakthrough infections, particularly with the emergence of the Omicron variant, did not result in increased anti-S1-RBD-IgG and -IgA levels. No significant induction of anti-S1-RBD-IgM was observed following multiple vaccine doses. The long-term investigation revealed that PPP and SSP groups had comparable humoral immune responses to SARS-CoV-2, highlighting the advantage of mRNA booster dose in our cohort.

这项前瞻性队列研究考察了在马来西亚接种过同种三剂 BNT162b2 疫苗(PPP)或两剂 CoronaVac 后接种 BNT162b2 加强剂(SSP)的 146 人在接种 COVID-19 疫苗后的长期体液免疫反应。研究采用 ELISA 方法,重点检测血清中的抗 S1-RBD-IgG、-IgA 和 -IgM。结果显示,BNT162b2 在两剂初级疫苗接种系列中的表现优于 CoronaVac。BNT162b2加强剂量可显著提高血清中抗S1-RBD-IgG和-IgA的水平,并且在接种后26周至52周内,无论采用哪种疫苗接种方案,血清中的抗S1-RBD-IgG和-IgA水平都会持续上升。这导致两组接种 BNT162b2 后的抗-S1-RBD-IgG 和-IgA 水平相当。突破性感染,尤其是奥米克龙变异株的出现,并没有导致抗-S1-RBD-IgG 和 -IgA水平的升高。多次接种疫苗后也没有观察到明显的抗-S1-RBD-IgM诱导。长期调查显示,PPP 组和 SSP 组对 SARS-CoV-2 的体液免疫反应不相上下,这凸显了 mRNA 强化剂量在我们队列中的优势。
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引用次数: 0
Anti-RBD IgG dynamics following infection or vaccination. 感染或接种疫苗后抗 RBD IgG 的动态变化。
Pub Date : 2024-12-02 Epub Date: 2024-10-20 DOI: 10.1016/j.vaccine.2024.126464
Amira Harrache, Kahina Saker, Bouchra Mokdad, Laurence Generenaz, Carla Saade, Sylvie Pons, Jean-Baptiste Fassier, Antonin Bal, Mary-Anne Trabaud, Muriel Rabilloud, Amna Abichou-Klich, Sophie Trouillet-Assant

Identifying parameters influencing SARS-CoV-2 antibody dynamics post infection or vaccination is crucial for refining vaccination strategies. In a longitudinal analysis of 1340 samples from 375 healthcare workers, we characterized peak serological response and IgG half-life. Peak antibody titers post 2 vaccine doses were ∼ 20 times higher than natural infection; conversely, infected individuals had extended antibody half-life. Clinical and demographical factors such as BMI, age and smoking shaped peak response without affecting anti-RBD IgG half-life. A third mRNA vaccine dose increased peak antibody titers and prolonged half-life compared to the second dose. These findings underscore the diverse kinetics of SARS-CoV-2 antibody responses, which is influenced by immunization type/number and clinical factors.

确定影响感染或接种后 SARS-CoV-2 抗体动态的参数对于改进疫苗接种策略至关重要。我们对来自 375 名医护人员的 1340 份样本进行了纵向分析,确定了血清反应峰值和 IgG 半衰期。接种 2 剂疫苗后的抗体滴度峰值比自然感染高 20 倍;相反,感染者的抗体半衰期延长。临床和人口统计学因素(如体重指数、年龄和吸烟)会影响峰值反应,但不会影响抗 RBD IgG 的半衰期。与第二剂相比,第三剂 mRNA 疫苗可提高抗体滴度峰值并延长半衰期。这些研究结果表明,SARS-CoV-2 抗体反应的动力学变化受免疫类型/次数和临床因素的影响。
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引用次数: 0
Documenting human papillomavirus vaccine refusal among adolescents in electronic health records: A mixed methods study. 在电子健康记录中记录青少年拒绝接种人类乳头瘤病毒疫苗的情况:一项混合方法研究。
Pub Date : 2024-12-02 Epub Date: 2024-10-29 DOI: 10.1016/j.vaccine.2024.126467
Nadja A Vielot, Christine A P Ballard, Denise T St Jean, Sophie Page, Kelli Hammond, Peyton Thompson, Anne M Butler, Leah M Ranney

Background: Human papillomavirus (HPV) vaccination is often refused by patients or caregivers. We conducted a mixed-methods study to understand how health care providers document HPV vaccination refusal and use this information in subsequent encounters.

Methods: Using electronic health records (EHR) in a public academic health system, we identified patients aged 9-17 years with documentation of refusal of a recommended vaccination in billing codes or clinic notes from October 15, 2015 and December 31, 2021. We summarized the number of encounters in which vaccination was refused; the incidence of HPV vaccination following an initial refusal; and the content of clinic notes describing HPV vaccination refusal. Next, we held focus groups with clinic personnel to understand strategies for documenting HPV vaccination refusal and holding future conversations about HPV vaccination.

Results: Of 523 patients with a documented vaccination refusal, 351 (67 %) refused HPV. Of these, 88 (27 %) eventually received HPV vaccination; incidence of vaccination was not associated with the method used to document refusal in the EHR (ICD-10 code versus clinic note). From focus group discussions, we learned that providers usually make brief notes describing when HPV vaccination was offered and refused, and generally plan to recommend vaccination again at a subsequent encounter. Documenting specific reasons for refusal (e.g., patient age, a conflicting priority) was considered helpful to guide future conversations.

Conclusions: Patients who refuse HPV vaccination might accept vaccination in the future if providers continue to recommend it. Documenting the refusal in EHR can provide meaningful context to guide subsequent recommendations.

背景:人乳头瘤病毒 (HPV) 疫苗接种经常遭到患者或护理人员的拒绝。我们开展了一项混合方法研究,以了解医疗服务提供者如何记录 HPV 疫苗接种拒绝并在后续接种中使用这些信息:我们使用公共学术卫生系统的电子健康记录(EHR),确定了从 2015 年 10 月 15 日到 2021 年 12 月 31 日期间在账单代码或门诊笔记中记录拒绝接受推荐疫苗接种的 9-17 岁患者。我们总结了拒绝接种疫苗的就诊次数、首次拒绝接种后接种 HPV 疫苗的发生率以及诊所记录中描述拒绝接种 HPV 疫苗的内容。接下来,我们与诊所人员进行了焦点小组讨论,以了解记录拒绝接种 HPV 疫苗的策略以及今后就 HPV 疫苗接种进行对话的策略:在 523 名有拒绝接种记录的患者中,有 351 人(67%)拒绝接种 HPV。其中,88 人(27%)最终接受了 HPV 疫苗接种;疫苗接种率与 EHR 中记录拒绝接种的方法(ICD-10 代码与门诊单)无关。从焦点小组的讨论中,我们了解到医疗服务提供者通常会做简要记录,描述何时提供和拒绝接受 HPV 疫苗接种,并通常计划在随后的就诊中再次建议接种疫苗。记录具体的拒绝原因(如患者年龄、优先事项冲突)被认为有助于指导今后的对话:结论:如果医疗服务提供者继续推荐接种,拒绝接种 HPV 疫苗的患者将来可能会接受接种。在电子病历中记录拒绝接种的情况可提供有意义的背景信息,为后续建议提供指导。
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引用次数: 0
Risk of major adverse cerebro-cardiovascular events following BNT162b2, CoronaVac, and ChAdOx1 vaccination and SARS-CoV-2 infection: A self-controlled case-series study. 接种 BNT162b2、CoronaVac 和 ChAdOx1 疫苗以及感染 SARS-CoV-2 后发生重大脑心血管不良事件的风险:一项自我对照病例系列研究。
Pub Date : 2024-12-02 Epub Date: 2024-10-23 DOI: 10.1016/j.vaccine.2024.126465
Norazida Ab Rahman, Teck Long King, Kalaiarasu M Peariasamy, Sheamini Sivasampu

Objective: To assess the potential risk of major adverse cerebro-cardiovascular events (MACCE) associated with COVID-19 vaccination and SARS-CoV-2 infection.

Methods: This self-controlled case series study used nationwide health database from Malaysia. The study included individuals aged ≥18 years who were hospitalised between 24 February 2021 and 30 June 2022. Outcomes were composite of MACCE: stroke, acute ischaemic heart disease, and cardiovascular death. Exposures were COVID-19 vaccination and SARS-CoV-2 infection. The risk period was day 1 to day 21 following exposure. Conditional Poisson regression model was used to estimate the incidence rate ratios (IRRs) and 95 % confidence interval (CI) comparing the outcomes in the risk and control periods.

Results: The risk of MACCE within 21 days after vaccination per 100,000 doses administered were 12.0 (95% CI 11.9-12.1) (BNT162b2), 9.2 (95% CI 9.1-9.3) (CoronaVac), and 6.8 (95% CI 6.6-7.0) (ChAdOx1). The incidence rate ratios showed no increased risk of MACCE associated with the first, second, or third doses of BNT162b2, CoronaVac, and ChAdOx1 vaccines for individuals without prior cardiovascular disease (CVD). This finding was consistent for individuals with CVD. Vaccine booster dose, whether in a homologous or heterologous schedule, did not show increased risk of MACCE. Analysis by ethnic groups detected a slightly elevated risk of MACCE in Indian after the first dose of ChAdOx1 (IRR 1.64; 95% CI 1.08-2.48) in those without CVD. No significant association were observed in other subgroup analyses. SARS-CoV-2 infection was associated with significantly increased risk of MACCE in individuals without CVD (IRR 3.54; 95% CI 3.32-3.76) and with CVD (IRR 1.98; 95% CI 1.61-2.34).

Conclusions: Our findings support the favourable safety profile of these COVID-19 vaccines and indicate that the overall benefit-risk ratio of the COVID-19 vaccines remains positive.

目的评估与 COVID-19 疫苗接种和 SARS-CoV-2 感染相关的重大不良脑-心血管事件 (MACCE) 的潜在风险:这项自我对照病例系列研究使用了马来西亚全国健康数据库。研究对象包括 2021 年 2 月 24 日至 2022 年 6 月 30 日期间住院的年龄≥18 岁的人。研究结果是MACCE的综合结果:中风、急性缺血性心脏病和心血管死亡。暴露因素为 COVID-19 疫苗接种和 SARS-CoV-2 感染。风险期为暴露后的第 1 天至第 21 天。采用条件泊松回归模型估算了风险期和对照期结果的发病率比(IRR)和95%置信区间(CI):每 10 万剂疫苗接种后 21 天内发生 MACCE 的风险分别为 12.0(95% CI 11.9-12.1)(BNT162b2)、9.2(95% CI 9.1-9.3)(CoronaVac)和 6.8(95% CI 6.6-7.0)(ChAdOx1)。发病率比显示,对于未患心血管疾病 (CVD) 的人来说,接种第一、第二或第三剂 BNT162b2、CoronaVac 和 ChAdOx1 疫苗不会增加 MACCE 风险。对于患有心血管疾病的人来说,这一结果是一致的。无论是同源疫苗还是异源疫苗,疫苗加强剂量都不会增加 MACCE 风险。按种族群体进行的分析发现,印度人在首次接种 ChAdOx1 后发生 MACCE 的风险略有升高(IRR 为 1.64;95% CI 为 1.08-2.48)。在其他亚组分析中未观察到明显关联。在无心血管疾病(IRR为3.54;95% CI为3.32-3.76)和有心血管疾病(IRR为1.98;95% CI为1.61-2.34)的人群中,SARS-CoV-2感染与MACCE风险显著增加有关:我们的研究结果支持COVID-19疫苗良好的安全性,并表明COVID-19疫苗的总体效益风险比仍然是积极的。
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引用次数: 0
Exploring risk factors for Raynaud's phenomenon post COVID-19 vaccination. 探索接种 COVID-19 疫苗后出现雷诺现象的风险因素。
Pub Date : 2024-12-02 Epub Date: 2024-10-29 DOI: 10.1016/j.vaccine.2024.126470
Tzu-Chuan Ho, Shih-Chang Chuang, Kuo-Chen Hung, Chin-Chuan Chang, Kuo-Pin Chuang, Cheng-Hui Yuan, Ming-Hui Yang, Yu-Chang Tyan

Background: Raynaud's phenomenon (RP) has recently been observed in recipients of the COVID-19 vaccine. It is unclear whether RP is directly caused by the COVID-19 vaccine. This study aims to investigate the potential causation between RP and COVID-19 vaccination.

Methods: In this study, we searched PubMed, EMBASE, and Web of Science from January 1, 2020, to March 19, 2024. We included the articles with clinical related findings, specifically case reports and case series. Conference abstracts, editorial publications, preprint, and those not specifically related to COVID-19 vaccination are excluded. The refined selection process aimed to ensure a focused and clinically relevant analysis of the association between RP and COVID-19 vaccination.

Results: A total of six articles were ultimately included in this study, comprising five case reports and one case series involving 24 patients with RP after vaccination. Baseline characteristics of the studies showed the RP post COVID-19 vaccination frequently occurred with females compared to males (70.83 vs. 29.17 %). Of the patients with RP post COVID-19 vaccination, 87.5 % (21/24) had either a history or possible predisposing factors of RP. Among the patients with detailed information of vaccination (n = 20), the number of vaccine doses was not related to RP development (45 % (1st) vs. 30 % (2nd) vs. 25 % 3rd dose). For types of vaccine, 75 % of RP were found to have received the administration of mRNA vaccine (15/20).

Conclusion: The risk of bias was increased due to the uncontrolled study designs and small sample size, making it impossible to attribute causation between RP and COVID-19 vaccination. These few cases may have occurred independently of vaccination. However, physicians should still remain vigilant for RP following COVID-19 vaccination, particularly as the number of vaccinated individuals continues to rise.

背景:最近在 COVID-19 疫苗接种者中发现了雷诺现象(RP)。目前尚不清楚雷诺现象是否由 COVID-19 疫苗直接引起。本研究旨在调查 RP 与接种 COVID-19 疫苗之间的潜在因果关系:在本研究中,我们检索了 2020 年 1 月 1 日至 2024 年 3 月 19 日期间的 PubMed、EMBASE 和 Web of Science。我们收录了与临床研究结果相关的文章,特别是病例报告和系列病例。会议摘要、编辑出版物、预印本以及与 COVID-19 疫苗接种无关的文章均被排除在外。精选过程旨在确保对RP与COVID-19疫苗接种之间的关联进行有针对性的临床相关分析:本研究最终共纳入了六篇文章,包括五篇病例报告和一篇系列病例,涉及 24 名接种疫苗后出现 RP 的患者。研究的基线特征显示,接种 COVID-19 疫苗后出现 RP 的女性多于男性(70.83% 对 29.17%)。在接种 COVID-19 疫苗后出现 RP 的患者中,87.5%(21/24)有 RP 病史或可能的易感因素。在有详细疫苗接种信息的患者(20 人)中,疫苗接种次数与 RP 的发生无关(45%(第 1 剂) vs. 30%(第 2 剂) vs. 25%(第 3 剂))。就疫苗类型而言,75%的RP患者接种了mRNA疫苗(15/20):结论:由于研究设计不受控制且样本量较小,偏倚风险增加,因此无法确定RP与COVID-19疫苗接种之间的因果关系。这些少数病例的发生可能与疫苗接种无关。不过,医生仍应警惕接种 COVID-19 疫苗后的 RP,尤其是随着接种人数的不断增加。
{"title":"Exploring risk factors for Raynaud's phenomenon post COVID-19 vaccination.","authors":"Tzu-Chuan Ho, Shih-Chang Chuang, Kuo-Chen Hung, Chin-Chuan Chang, Kuo-Pin Chuang, Cheng-Hui Yuan, Ming-Hui Yang, Yu-Chang Tyan","doi":"10.1016/j.vaccine.2024.126470","DOIUrl":"10.1016/j.vaccine.2024.126470","url":null,"abstract":"<p><strong>Background: </strong>Raynaud's phenomenon (RP) has recently been observed in recipients of the COVID-19 vaccine. It is unclear whether RP is directly caused by the COVID-19 vaccine. This study aims to investigate the potential causation between RP and COVID-19 vaccination.</p><p><strong>Methods: </strong>In this study, we searched PubMed, EMBASE, and Web of Science from January 1, 2020, to March 19, 2024. We included the articles with clinical related findings, specifically case reports and case series. Conference abstracts, editorial publications, preprint, and those not specifically related to COVID-19 vaccination are excluded. The refined selection process aimed to ensure a focused and clinically relevant analysis of the association between RP and COVID-19 vaccination.</p><p><strong>Results: </strong>A total of six articles were ultimately included in this study, comprising five case reports and one case series involving 24 patients with RP after vaccination. Baseline characteristics of the studies showed the RP post COVID-19 vaccination frequently occurred with females compared to males (70.83 vs. 29.17 %). Of the patients with RP post COVID-19 vaccination, 87.5 % (21/24) had either a history or possible predisposing factors of RP. Among the patients with detailed information of vaccination (n = 20), the number of vaccine doses was not related to RP development (45 % (1st) vs. 30 % (2nd) vs. 25 % 3rd dose). For types of vaccine, 75 % of RP were found to have received the administration of mRNA vaccine (15/20).</p><p><strong>Conclusion: </strong>The risk of bias was increased due to the uncontrolled study designs and small sample size, making it impossible to attribute causation between RP and COVID-19 vaccination. These few cases may have occurred independently of vaccination. However, physicians should still remain vigilant for RP following COVID-19 vaccination, particularly as the number of vaccinated individuals continues to rise.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":"42 26","pages":"126470"},"PeriodicalIF":0.0,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142524052","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Comparing COVID-19 booster vaccine acceptance in the United Kingdom, Germany, Austria, and Jordan: The role of protection motivation theory, conspiracy beliefs, social media use and religiosity. 比较英国、德国、奥地利和约旦对 COVID-19 强化疫苗的接受程度:保护动机理论、阴谋论信仰、社交媒体使用和宗教信仰的作用。
Pub Date : 2024-12-02 Epub Date: 2024-10-29 DOI: 10.1016/j.vaccine.2024.126474
Judith Eberhardt, Walid Al-Qerem, Jonathan Ling

Background: Coronavirus Disease 2019 (COVID-19) booster vaccine uptake has been lower than that of the initial vaccine doses in many countries. Approaches to vaccination vary, with some countries implementing mandatory vaccination and others not. This study aimed to predict COVID-19 booster vaccination intention using Protection Motivation Theory (PMT), coronavirus conspiracy beliefs, social media use, and sociodemographic factors, comparing the United Kingdom (UK), Jordan, Germany, and Austria.

Methods: A cross-sectional online survey was conducted in the UK, Germany, Austria, and Jordan. Convenience sampling was used to recruit 287 fully vaccinated participants. The survey included items measuring PMT constructs, conspiracy beliefs, social media use, and sociodemographic variables. Data were analysed using bivariate analysis and binary logistic regression.

Results: Participants with high booster dose intention showed lower religiosity, conspiracy beliefs, perceived rewards of not getting vaccinated, and perceived costs of getting vaccinated. They had higher Twitter use, perceived susceptibility, severity of COVID-19, self-efficacy, and vaccine efficacy. Four PMT constructs (severity, self-efficacy, maladaptive response rewards, and response efficacy) significantly predicted booster dose intention.

Conclusions: While PMT constructs predict booster vaccination intention, additional factors such as conspiracy beliefs, social media use, and religiosity need to be taken into account in public health campaigns to increase COVID-19 booster dose uptake.

背景:在许多国家,2019 年冠状病毒病(COVID-19)强化疫苗的接种率低于首剂疫苗的接种率。接种疫苗的方法各不相同,有些国家实施强制接种,有些国家则没有。本研究旨在比较英国(UK)、约旦、德国和奥地利的情况,利用保护动机理论(PMT)、冠状病毒阴谋信念、社交媒体使用和社会人口学因素预测 COVID-19 强化疫苗接种意向:在英国、德国、奥地利和约旦开展了一项横断面在线调查。采用便利抽样的方式招募了 287 名完全接种过疫苗的参与者。调查项目包括 PMT 构建、阴谋论信念、社交媒体使用和社会人口变量。采用二元分析和二元逻辑回归对数据进行了分析:结果:加强接种意向高的参与者的宗教信仰、阴谋信念、不接种疫苗的感知回报和接种疫苗的感知成本均较低。他们的推特使用率、感知易感性、COVID-19 的严重程度、自我效能和疫苗效价都较高。四个 PMT 构建(严重程度、自我效能、不良反应奖励和反应效能)可显著预测加强接种意向:结论:虽然 PMT 构建可预测加强接种意向,但在公共卫生活动中还需考虑阴谋论信仰、社交媒体使用和宗教信仰等其他因素,以提高 COVID-19 加强剂型的接种率。
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引用次数: 0
Intravenous BCG vaccination in non-human primates induces superior serum antibody titers with enhanced avidity and opsonizing capacity compared to the intradermal route. 与皮内途径相比,非人灵长类动物静脉注射卡介苗可诱导更高的血清抗体滴度,并具有更强的抗体亲和力和蛋白吸附能力。
Pub Date : 2024-12-02 Epub Date: 2024-11-10 DOI: 10.1016/j.vaccine.2024.126444
Marco Polo Peralta Alvarez, Keya Downward, Andrew White, Stephanie A Harris, Iman Satti, Shuailin Li, Alexandra Morrison, Laura Sibley, Charlotte Sarfas, Mike Dennis, Hugo Redondo Azema, Sally Sharpe, Helen McShane, Rachel Tanner

A new and more effective tuberculosis (TB) vaccine is urgently needed, but development is hampered by the lack of validated immune correlates of protection. Bacillus Calmette Guérin (BCG) vaccination by the aerosol (AE) and intravenous (IV) routes has been shown to confer superior levels of protection from challenge with Mycobacterium tuberculosis (M.tb) in non-human primates (NHP) compared with standard intradermal (ID) administration. This finding offers a valuable opportunity to investigate which aspects of immunity are associated with improved control of M.tb and may represent biomarkers or correlates of protection. As TB vaccine research to date has focused largely on cellular immunity, we aimed to better characterize the poorly-understood serum antibody response to BCG administered by different routes of vaccination in NHP. We demonstrate superior M.tb-specific IgG, IgA, and IgM titers in serum following IV BCG vaccination compared to the ID or AE routes. We also observe improved capacity of IgG induced by IV BCG to opsonize the surface of mycobacteria, and report for the first time that M.tb-specific IgG from IV BCG vaccinated animals is of higher avidity compared with IgG from ID or AE BCG vaccinated animals. Notably, we identified a significant correlation between IgG avidity and measures of protection from aerosol M.tb challenge. Our findings highlight a potential role for antibodies as markers and/or mediators of the superior vaccine-induced protection IV BCG confers against TB and suggest that quality, as well as quantity, of antibodies should be considered when developing and evaluating TB vaccine candidates.

目前迫切需要一种新的、更有效的结核病(TB)疫苗,但由于缺乏有效的免疫保护相关因素,疫苗的开发受到了阻碍。通过气溶胶(AE)和静脉注射(IV)途径接种卡介苗(BCG)已证明,与标准皮内注射(ID)相比,在非人灵长类动物(NHP)中接种卡介苗可在结核分枝杆菌(M.tb)挑战下提供更高水平的保护。这一发现为研究免疫力的哪些方面与更好地控制结核分枝杆菌有关并可能代表保护的生物标志物或相关因素提供了宝贵的机会。由于迄今为止的结核病疫苗研究主要集中在细胞免疫方面,我们的目标是更好地描述人们对卡介苗在NHP中不同接种途径下的血清抗体反应知之甚少。与ID或AE途径相比,我们证明静脉注射卡介苗后血清中的M.tb特异性IgG、IgA和IgM滴度更高。我们还观察到静脉注射卡介苗诱导的 IgG 对分枝杆菌表面的蛋白溶解能力有所提高,并首次报告了静脉注射卡介苗动物的 M.tb 特异性 IgG 与 ID 或 AE 卡介苗动物的 IgG 相比具有更高的亲和力。值得注意的是,我们确定了 IgG 阳性度与气溶胶 M.tb 挑战保护措施之间的显著相关性。我们的研究结果突显了抗体作为IV型卡介苗诱导的针对结核病的卓越保护作用的标记物和/或介质的潜在作用,并建议在开发和评估结核病候选疫苗时应考虑抗体的质量和数量。
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引用次数: 0
On-time childhood vaccination before and during the COVID-19 pandemic in seven communities: Findings from the New Vaccine Surveillance Network. 七个社区在 COVID-19 大流行之前和期间按时接种儿童疫苗的情况:新疫苗监测网络的调查结果。
Pub Date : 2024-12-02 Epub Date: 2024-10-30 DOI: 10.1016/j.vaccine.2024.126455
Annika M Hofstetter, Eileen J Klein, Bonnie Strelitz, Rangaraj Selvarangan, Jennifer E Schuster, Julie A Boom, Leila C Sahni, Natasha B Halasa, Laura S Stewart, Mary Allen Staat, Chelsea Rohlfs, Peter G Szilagyi, Geoffrey A Weinberg, John V Williams, Marian G Michaels, Heidi Moline, Sara A Mirza, Christopher J Harrison, Janet A Englund

Background: The COVID-19 pandemic raised unprecedented challenges to vaccinating children. This multi-center study aimed to compare on-time vaccination of children before and during the COVID-19 pandemic and identify key factors associated with on-time vaccination.

Methods: This study was conducted among children aged 0-6 years enrolled in the New Vaccine Surveillance Network at seven geographically diverse U.S. academic medical centers. Children with acute respiratory illness or acute gastroenteritis were enrolled from emergency department and inpatient settings; healthy control subjects were enrolled from primary care practices. Vaccination data were collected and verified from patient medical records, immunization information systems, and/or provider documentation. On-time vaccination according to Advisory Committee on Immunization Practices recommendations was compared between pre-pandemic (December 2018-February 2020) and pandemic (March 2020-August 2021) periods using bivariate and multivariable analyses, adjusting for key demographic, clinical, and study characteristics.

Results: A total of 24,713 children were included in the analytic sample (non-Hispanic 73.4 %; White 51.0 %; publicly insured 69.0 %). On-time vaccination declined between the pre-pandemic (67.3 %) and pandemic (65.4 %) periods (Adjusted Odds Ratio 0.89, 95 % CI 0.84-0.95). The largest declines were observed among children who were < 12 months, male, Black, publicly insured, or whose mothers had a high school-equivalent education or less. The pandemic impact also varied by vaccine type and study site.

Conclusions: This multi-center study revealed a relatively modest overall reduction in on-time vaccination, which may reflect multilevel efforts to address pandemic-associated challenges. However, some patient subgroups and sites experienced greater reductions in on-time vaccination, highlighting the importance of tailoring interventions to increase equitable vaccine delivery, access, and acceptance across populations and communities.

背景:COVID-19 大流行给儿童疫苗接种带来了前所未有的挑战。这项多中心研究旨在比较 COVID-19 大流行之前和期间儿童按时接种疫苗的情况,并确定与按时接种疫苗相关的关键因素:这项研究在美国七个地理位置不同的学术医疗中心的新疫苗监测网络中登记的 0-6 岁儿童中进行。患急性呼吸道疾病或急性肠胃炎的儿童来自急诊科和住院部;健康对照组则来自初级保健机构。疫苗接种数据通过患者病历、免疫信息系统和/或医疗服务提供者的文件进行收集和核实。根据免疫实践咨询委员会的建议,使用双变量和多变量分析比较了大流行前(2018 年 12 月至 2020 年 2 月)和大流行期间(2020 年 3 月至 2021 年 8 月)的按时接种情况,并对主要人口统计学、临床和研究特征进行了调整:共有 24713 名儿童被纳入分析样本(非西班牙裔 73.4%;白人 51.0%;公共保险 69.0%)。大流行前(67.3%)和大流行期间(65.4%)按时接种疫苗的比例有所下降(调整后比值比 0.89,95 % CI 0.84-0.95)。得出结论的儿童死亡率下降幅度最大:这项多中心研究显示,按时接种疫苗的总体下降幅度相对较小,这可能反映了为应对大流行相关挑战所做的多层次努力。然而,一些患者亚群和接种点的按时接种率下降幅度更大,这凸显了调整干预措施以提高疫苗在不同人群和社区中的公平接种率、可及性和接受度的重要性。
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引用次数: 0
Acute autoimmune hepatitis following COVID-19 mRNA vaccination: A population-based study using electronic health records in Singapore. 接种 COVID-19 mRNA 疫苗后出现急性自身免疫性肝炎:利用新加坡电子健康记录开展的一项基于人群的研究。
Pub Date : 2024-12-02 Epub Date: 2024-10-24 DOI: 10.1016/j.vaccine.2024.126462
Amelia Jing Jing Ng, Desmond Chun Hwee Teo, Sreemanee Raaj Dorajoo, Aaron Jun Yi Yap, Wan Cheng Chow, Nicholas Kai Ming Ng, Sally Bee Leng Soh

Reports of coronavirus disease 2019 (COVID-19) vaccine-induced autoimmune hepatitis (AIH) have been largely limited to case reports and case series. To further investigate the association between COVID-19 mRNA vaccination and AIH, we conducted a nationwide study using observed-over-expected (O/E) and Self-Controlled Case Series (SCCS) analyses for acute presentations of AIH (AAIH) warranting admission. Patients were included if they had one or more of the following hepatitis-related signs and symptoms (fever, lethargy, jaundice or abdominal pain) reported up to 3 months prior to admission, deranged liver function tests [alanine transaminase (ALT) or aspartate aminotransferase (AST) greater than three times the upper limit of laboratory reference ranges], as well as biopsy results characteristic of AIH or response to steroid treatment for cases which did not undergo biopsy. Seventy-six patients fulfilled our case definition of AAIH within the study period from 1 January 2019 to 28 February 2023, with 6 patients having an estimated onset of AAIH within 42 days of COVID-19 mRNA vaccination. All 6 patients were females aged 40 years and above. In the O/E analysis, the rate ratios of AAIH among females aged 40 years and above in the primary cohort were 1.12 (95% confidence interval (CI) 0.14-9.40) and 1.06 (95% CI 0.24-4.74) in the 21 days and 42 days following vaccination respectively. In the SCCS analysis, we did not observe any statistically significant increase in incidence of AAIH in the 21 and 42 days following COVID-19 mRNA vaccination for both the primary and supplementary cohorts, as well as in the subgroup analysis involving females aged 40 years and above. Our findings suggest that COVID-19 mRNA vaccination does not appear to be associated with increased risk of AAIH requiring admissions in the population, although larger studies are required to confirm these findings.

有关2019年冠状病毒病(COVID-19)疫苗诱发自身免疫性肝炎(AIH)的报道大多局限于病例报告和病例系列。为了进一步研究 COVID-19 mRNA 疫苗接种与自身免疫性肝炎之间的关系,我们在全国范围内开展了一项研究,采用观察-超预期(O/E)和自控病例系列(SCCS)分析方法,对需要入院的急性自身免疫性肝炎(AAIH)进行分析。如果患者在入院前 3 个月内出现以下一种或多种肝炎相关症状和体征(发热、嗜睡、黄疸或腹痛),肝功能检测异常[丙氨酸转氨酶 (ALT) 或天冬氨酸转氨酶 (AST) 超过实验室参考范围上限的三倍],以及活检结果具有 AIH 特征或对类固醇治疗有反应(未进行活检的病例),则可纳入该患者。在2019年1月1日至2023年2月28日的研究期间,有76名患者符合我们对AAIH病例的定义,其中6名患者估计在接种COVID-19 mRNA疫苗后42天内发病。所有 6 名患者均为女性,年龄在 40 岁及以上。在 O/E 分析中,接种疫苗后 21 天和 42 天内 40 岁及以上女性的 AAIH 比率分别为 1.12(95% 置信区间 (CI):0.14-9.40)和 1.06(95% 置信区间 (CI):0.24-4.74)。在SCCS分析中,我们没有观察到接种COVID-19 mRNA疫苗后21天和42天内AAIH发病率有任何统计学意义上的显著增加,无论是在主要队列和补充队列中,还是在涉及40岁及以上女性的亚组分析中。我们的研究结果表明,接种 COVID-19 mRNA 疫苗似乎与需要入院治疗的 AAIH 风险增加无关,但需要更大规模的研究来证实这些结果。
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引用次数: 0
Estimating influenza vaccine effectiveness among older adults using an integrated administrative database and the implications of potential bias: A population-based cohort study in Japan. 利用综合行政数据库估算老年人接种流感疫苗的效果以及潜在偏差的影响:日本一项基于人群的队列研究。
Pub Date : 2024-12-02 Epub Date: 2024-10-31 DOI: 10.1016/j.vaccine.2024.126488
Ayu Kasamatsu, Yuichiro Yahata, Wakaba Fukushima, Hirofumi Sakamoto, Kaori Tanaka, Miwa Takigawa, Kaori Izu, Yuko Nishino, Motoi Suzuki, Hajime Kamiya

Background: Japan lacks an established framework for routine seasonal influenza vaccine effectiveness (SIVE) assessment at the national and municipal levels. This study aimed to estimate SIVE among older adults using an innovative population-based administrative database linking medical fee claims data with vaccination records, while also exploring its potential bias.

Methods: In this retrospective population-based cohort study, we assessed SIVE against medically attended influenza during the 2017/18 season among older adults aged ≥65 years in a Japanese city. A Cox proportional hazards model was used to estimate hazard rate ratios, treating vaccination status as time-dependent. To explore potential biases, multivariate logistic regression analysis was used to investigate the association between vaccination status and acute respiratory infection (ARI) diagnosis and trauma/injury during the non-influenza season.

Results: This study included 82 % (n = 110,892) of the city's older adult population, with 39.7 % vaccination coverage. The estimated SIVE was 2.9 % (95 % confidence interval: -6.2-11.2), showing no statistical significance. Similarly, subgroup analyses by age and comorbidities revealed no significant protective effect of SIVE. In the non-season analysis, adjusted odds ratios of vaccination were significantly higher for ARI [1.3 (1.3-1.4)] and trauma/injury [1.2 (1.1-1.2)]. However, no significance was observed for hospitalizations with these diagnoses, which include severe conditions less associated with healthcare-seeking behaviors [0.9 (0.8-1.1) and 0.8 (0.6-1.0), respectively].

Conclusions: No significant SIVE was observed during the 2017/18 season. Our real-world observational study, based on medical fee claims data, indicates a potential underestimation of SIVE owing to bias related to healthcare-seeking behaviors.

背景:日本在国家和市级层面缺乏常规季节性流感疫苗有效性(SIVE)评估的既定框架。本研究旨在利用一个创新的基于人口的行政数据库,将医疗费用报销数据与疫苗接种记录联系起来,对老年人的 SIVE 进行评估,同时探讨其潜在的偏差:在这项以人群为基础的回顾性队列研究中,我们评估了日本某市年龄≥65岁的老年人在2017/18年流感季节接种流感疫苗的SIVE情况。我们采用 Cox 比例危险模型来估算危险率比,并将疫苗接种状况视为时间依赖因素。为了探究潜在的偏差,研究人员采用了多变量逻辑回归分析来研究疫苗接种情况与非流感季节急性呼吸道感染(ARI)诊断和外伤/损伤之间的关系:这项研究包括该市 82% 的老年人口(n = 110,892 人),疫苗接种覆盖率为 39.7%。估计 SIVE 为 2.9 %(95 % 置信区间:-6.2-11.2),无统计学意义。同样,按年龄和合并症进行的亚组分析显示,SIVE 没有显著的保护作用。在非季节分析中,急性呼吸道感染[1.3 (1.3-1.4)]和创伤/受伤[1.2 (1.1-1.2)]的调整后接种几率比明显更高。然而,对于因这些诊断而住院的情况(包括与寻求医疗保健行为不太相关的严重情况),没有观察到明显的差异[分别为 0.9 (0.8-1.1) 和 0.8 (0.6-1.0)]:2017/18赛季未观察到明显的SIVE。我们基于医疗费用报销数据的真实世界观察研究表明,由于与寻求医疗保健行为相关的偏差,SIVE可能被低估。
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引用次数: 0
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