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A review of the immunogenicity and safety of booster doses of omicron variant-containing mRNA-1273 COVID-19 vaccines in adults and children. 成人和儿童接种含 mRNA-1273 COVID-19 的奥米克变体疫苗的免疫原性和安全性综述。
IF 5.5 3区 医学 Q1 IMMUNOLOGY Pub Date : 2024-01-01 Epub Date: 2024-09-09 DOI: 10.1080/14760584.2024.2397026
Frances Priddy, Spyros Chalkias, Brandon Essink, Jordan Whatley, Adam Brosz, Ivan T Lee, Jing Feng, LaRee Tracy, Weiping Deng, Wen Zhou, Honghong Zhou, Avika Dixit, Sabine Schnyder-Ghamloush, Bethany Girard, Elizabeth de Windt, Anne Yeakey, Jacqueline Miller, Rituparna Das, Barbara J Kuter

Introduction: Vaccination against SARS-CoV-2 is an integral pillar of the public health approach to COVID-19. With the emergence of variants of concern that increase transmissibility and escape from vaccine- or infection-induced protection, vaccines have been developed to more closely match the newly circulating SARS-CoV-2 strains to improve protection. The safety and immunogenicity of multiple authorized messenger RNA (mRNA)-based COVID-19 vaccines targeting the omicron sublineage (BA.1, BA.4/BA.5, and XBB.1.5) have been demonstrated in several clinical trials among adults and children.

Areas covered: This review will comprehensively detail the available evidence (published through July 2024) from ongoing clinical trials on omicron variant-containing mRNA-1273 vaccines administered as additional doses in previously vaccinated target demographics.

Expert opinion: Across three clinical trials, omicron variant-containing mRNA-1273 vaccines induced immune responses to vaccine-matched omicron strains as well as ancestral SARS-CoV-2, with a safety and reactogenicity profile comparable to the original mRNA-1273 vaccine. Combined with pivotal data demonstrating the safety, efficacy, and effectiveness of the original mRNA-1273 vaccine, these findings support the use of variant-containing mRNA-1273 vaccines and provide confidence that expeditious development of updated vaccines using this established mRNA platform can maintain protection against COVID-19.

导言:接种 SARS-CoV-2 疫苗是应对 COVID-19 的公共卫生方法中不可或缺的支柱。随着令人担忧的变异株的出现,这些变异株增加了传播性,并可逃避疫苗或感染引起的保护,因此,人们开发了与新流行的 SARS-CoV-2 株更匹配的疫苗,以提高保护效果。在成人和儿童中进行的几项临床试验已经证明了多种已获授权的基于信使 RNA (mRNA) 的 COVID-19 疫苗的安全性和免疫原性,这些疫苗以奥米克次系(BA.1、BA.4/BA.5 和 XBB.1.5)为目标:本综述将全面详述目前正在进行的含奥米克龙变体 mRNA-1273 疫苗临床试验的现有证据(截至 2023 年 12 月已发表),这些临床试验是在之前接种过疫苗的目标人群中作为额外剂量接种的:在三项临床试验中,含有 omicron 变异株的 mRNA-1273 疫苗诱导了与疫苗匹配的 omicron 株以及祖先 SARS-CoV-2 的免疫反应,其安全性和致反应性与原始 mRNA-1273 疫苗相当。这些研究结果与证明原始 mRNA-1273 疫苗的安全性、有效性和有效性的关键数据相结合,支持了含变体的 mRNA-1273 疫苗的使用,并使人们相信,利用这一成熟的 mRNA 平台快速开发更新的疫苗可以保持对 COVID-19 的保护。
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引用次数: 0
Indirect protection in adults ≥18 years of age from pediatric pneumococcal vaccination: a review. 小儿肺炎球菌疫苗接种对≥18 岁成人的间接保护:综述。
IF 5.5 3区 医学 Q1 IMMUNOLOGY Pub Date : 2024-01-01 Epub Date: 2024-10-28 DOI: 10.1080/14760584.2024.2416229
Elmira Flem, Celine Mouawad, Arto A Palmu, Heather Platt, Kelly D Johnson, E David McIntosh, Jacobo Abadi, Ulrike K Buchwald, Kristen Feemster

Introduction: Infant immunization programs using pneumococcal conjugate vaccines (PCVs) have reduced the rates of pneumococcal disease through direct vaccine-induced protection in vaccinated children and through indirect protection in non-vaccinated children and adults.

Areas covered: This review summarizes current evidence on the indirect protection of adults conferred by pediatric pneumococcal vaccination, including the impact on invasive pneumococcal disease (IPD) incidence and mortality, pneumonia admissions, and nasopharyngeal carriage prevalence. Factors affecting indirect protection against IPD are also discussed.

Expert opinion: Pediatric immunization with PCVs has substantially decreased vaccine-serotype IPD and pneumonia through indirect protection in both older (≥65 years of age) and younger adults, including those with underlying medical conditions. However, serotype replacement by non-vaccine serotypes, the persistence of some vaccine serotypes, and divergence of serotypes between children and adults have limited the impact of pediatric PCV programs on adult populations. Designing complementary vaccines that leverage indirect protection from pediatric immunization and target the most prevalent adult serotypes may be a preferred strategy to maximize the public health impact of pneumococcal vaccination.

导言:使用肺炎球菌结合疫苗 (PCV) 的婴儿免疫计划通过疫苗对接种儿童的直接保护以及对未接种儿童和成人的间接保护,降低了肺炎球菌疾病的发病率:本综述总结了目前有关接种小儿肺炎球菌疫苗可间接保护成人的证据,包括对侵入性肺炎球菌疾病 (IPD) 发病率和死亡率、肺炎入院率以及鼻咽带菌流行率的影响。此外,还讨论了影响间接预防 IPD 的因素:小儿 PCV 免疫接种通过间接保护老年人(≥65 岁)和年轻人(包括有基础疾病者),大大降低了疫苗血清型 IPD 和肺炎的发病率。然而,血清型被非疫苗血清型替代、某些疫苗血清型的持续存在以及儿童和成人之间血清型的差异限制了儿科 PCV 计划对成人人群的影响。设计补充疫苗,利用儿科免疫接种的间接保护并针对最流行的成人血清型,可能是最大限度地提高肺炎球菌疫苗接种对公共卫生影响的首选策略。
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引用次数: 0
Global pandemic preparedness: learning from the COVID-19 vaccine development and distribution. 全球大流行病防备:从 COVID-19 疫苗的开发和分发中学习。
IF 5.5 3区 医学 Q1 IMMUNOLOGY Pub Date : 2024-01-01 Epub Date: 2024-08-30 DOI: 10.1080/14760584.2024.2395546
Suneth Agampodi, Ondari D Mogeni, Rebecca Chandler, Megha Pansuriya, Jerome H Kim, Jean-Louis Excler

Introduction: The COVID-19 pandemic catalyzed unprecedented vaccine innovation, revealing critical shortcomings in achieving equitable vaccine access and underscoring the need for a focused review of the lessons learned to inform future pandemic preparedness, with emphasis on vaccine delivery, equity, and challenges in LMICs.

Areas covered: We critically analyzed the pandemic vaccine development and distribution journey and the operational mechanisms that facilitated these achievements. For this purpose, we primarily searched pandemic vaccine stakeholder websites, reports, and publications. The analysis extends beyond the scientific narrative to address the 'how' of the process while anchoring the discussion on equity and global health security as fundamental to preparing for future pandemics.

Expert opinion: Drawing on the insights gained from the COVID-19 pandemic, we identify several key challenges requiring immediate attention to fortify preparedness for future pandemics. These are cultivating leadership in the field of vaccinology, guaranteeing equitable global access to diagnostics, therapeutic agents, and vaccines, securing adequate funding for ongoing research and development, ensuring the fair distribution of vaccines, and strategically allocating biomedical manufacturing facilities to ensure a balanced global production capacity. Addressing these challenges is imperative to establish a robust pandemic response framework and mitigate the impact of future global health crises.

导言:COVID-19 大流行推动了前所未有的疫苗创新,揭示了在实现公平获得疫苗方面存在的关键缺陷,并强调有必要重点回顾所吸取的经验教训,以便为未来的大流行病防备工作提供信息,重点是疫苗交付、公平性以及低收入和中等收入国家面临的挑战:我们认真分析了大流行病疫苗的开发和分发历程,以及促进这些成就的运行机制。为此,我们主要搜索了大流行疫苗利益相关者的网站、报告和出版物。分析超越了科学叙述的范畴,探讨了这一过程的 "如何",同时将公平和全球健康安全作为讨论的基础,为未来的大流行病做好准备:根据从 COVID-19 大流行中获得的启示,我们确定了需要立即关注的几个关键挑战,以加强对未来大流行病的准备。这些挑战包括:培养疫苗学领域的领导力;保证全球公平地获得诊断、治疗药物和疫苗;为正在进行的研发工作提供充足的资金;确保疫苗的公平分配;战略性地分配生物医学生产设施,以确保全球生产能力的平衡。要建立一个强有力的大流行病应对框架并减轻未来全球健康危机的影响,应对这些挑战势在必行。
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引用次数: 0
Vaccines against mpox: MVA-BN and LC16m8. Mpox 疫苗:MVA-BN 和 LC16m8。
IF 5.5 3区 医学 Q1 IMMUNOLOGY Pub Date : 2024-01-01 Epub Date: 2024-09-01 DOI: 10.1080/14760584.2024.2397006
John D Grabenstein, Adam Hacker

Introduction: Global outbreaks involving mpox clade IIb began in mid-2022. Today, clade IIb and clade I outbreaks continue. Reliable mpox vaccines can prevent serious mpox disease and death.

Areas covered: Globally, two vaccines hold mpox indications, regardless of mpox viral clade: MVA-BN (Bavarian Nordic) and LC16m8 (KM Biologics). This review summarizes the human and pivotal animal data establishing safety and efficacy for MVA-BN and LC16m8, including real-world evidence gathered during mpox outbreaks from 2022 through 2024.

Expert opinion: Some regulatory decisions for MVA-BN and LC16m8 followed pathways based on surrogate outcomes, including lethal-challenge studies in nonhuman primates, among other atypical aspects. Nonetheless, MVA-BN and LC16m8 hold unencumbered registration in multiple countries. Effectiveness of MVA-BN as primary preventive vaccination (PPV) in humans against clade IIb mpox is clear from real-world studies; effectiveness of LC16m8 against clade IIb is likely from surrogate endpoints. Effectiveness of MVA-BN and LC16m8 as PPV against more-lethal clade I is likely, based on animal-challenge studies with multiple orthopoxvirus species and other studies. Both vaccines have solid safety records. MVA-BN's replication incompetence favors adoption, whereas LC16m8 has more pediatric data. Additional real-world evidence, in additional geographic settings and special populations (e.g. pregnancy, immune suppression, atopic dermatitis), is needed.

导言:2022 年中期,全球开始爆发涉及麻风腮病毒 IIb 支系的疫情。如今,IIb支系和I支系疫情仍在继续。可靠的水痘疫苗可以预防严重的水痘疾病和死亡:在全球范围内,有两种天花疫苗拥有天花适应症,而不受天花病毒支系的限制:MVA-BN(巴伐利亚北欧公司)和 LC16m8(KM 生物公司)。本综述总结了确定 MVA-BN 和 LC16m8 安全性和有效性的人类和关键动物数据,包括在 2022 年至 2024 年期间爆发的水痘疫情中收集的真实证据:MVA-BN和LC16m8的一些监管决定遵循基于替代结果的途径,包括在非人灵长类动物中进行致命挑战研究,以及其他非典型方面。尽管如此,MVA-BN 和 LC16m8 仍在多个国家进行了无限制注册。从实际研究来看,MVA-BN 作为人类主要预防接种 (PPV) 疫苗对 IIb 支麻风腮的有效性是显而易见的;LC16m8 对 IIb 支麻风腮的有效性可能来自于替代终点。MVA-BN和LC16m8作为PPV对更致命的I支系的有效性很可能是基于对多种正痘病毒的动物挑战研究和其他研究。这两种疫苗都有可靠的安全性记录。MVA-BN 的复制能力较弱,因此更倾向于采用,而 LC16m8 则有更多的儿科数据。还需要在更多地区和特殊人群(如怀孕、免疫抑制、特应性皮炎)中获得更多的实际证据。
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引用次数: 0
Adult indication 13-valent pneumococcal conjugate vaccine clinical development overview: formulation, safety, immunogenicity (dosing and sequence), coadministration, and efficacy. 成人适应症 13 价肺炎球菌结合疫苗临床开发概述:配方、安全性、免疫原性(剂量和顺序)、联合用药和疗效。
IF 5.5 3区 医学 Q1 IMMUNOLOGY Pub Date : 2024-01-01 Epub Date: 2024-09-25 DOI: 10.1080/14760584.2024.2404636
Mark A Fletcher, Beate Schmoele-Thoma, Jelena Vojicic, Derek Daigle, Peter R Paradiso, Graciela Del Carmen Morales

Introduction: There was no 13-valent pneumococcal conjugate vaccine (PCV13) adult antibody concentration threshold regulatory criterion for licensure - unlike the pediatric indication; consequently, for the adult indication, PCV13 serotype-specific opsonophagocytic activity (OPA) geometric mean titer (GMT) values were immunobridged to the 23-valent plain polysaccharide vaccine (PPV23) to infer efficacy against invasive pneumococcal disease (IPD). Subsequently, a double-blind, randomized, controlled PCV13 efficacy trial (CAPiTA) was performed in community-living, older adults to confirm efficacy against vaccine-serotype IPD (VT-IPD) and establish efficacy against vaccine-serotype pneumococcal community-acquired pneumonia (VT-CAP).

Areas covered: This article summarizes 31 publications from the PCV13 adult indication clinical development trials and other PCV13 clinical studies, organized by formulation, reactogenicity and safety, immunogenicity, coadministration, and clinical efficacy.

Expert opinion: PCV13 had a favorable safety profile with an OPA response generally greater than PPV23 irrespective of age and of previous pneumococcal vaccination. PCV13 primed for enhanced immune responses with subsequent PCV13 or PPV23 dosing. Conversely, PPV23 was shown to blunt the response to subsequent PCV13. CAPiTA demonstrated PCV13 efficacy for at least five years against both VT-IPD and VT-CAP. The PCV13 clinical development program provided fundamental insights into this vaccine's adult-specific immune responses and confirmed the advantages of conjugate over plain polysaccharide technology.

简介:与儿科适应症不同,13 价肺炎球菌结合疫苗 (PCV13) 的成人抗体浓度阈值并不是获得许可的监管标准;因此,对于成人适应症,PCV13 血清特异性嗜溶性细胞活性 (OPA) 几何平均滴度 (GMT) 值与 23 价普通多糖疫苗 (PPV23) 进行了免疫比对,以推断其对侵袭性肺炎球菌疾病 (IPD) 的有效性。随后,在社区生活的老年人中开展了一项双盲、随机对照 PCV13 疗效试验(CAPiTA),以确认对疫苗血清型 IPD(VT-IPD)的疗效,并确定对疫苗血清型肺炎球菌社区获得性肺炎(VT-CAP)的疗效:本文总结了 PCV13 成人适应症临床开发试验和其他 PCV13 临床研究中的 31 篇文献,按制剂、反应原性和安全性、免疫原性、联合用药和临床疗效进行了分类:PCV13具有良好的安全性,其OPA反应普遍高于PPV23,与年龄和既往接种肺炎球菌疫苗的情况无关。PCV13 可增强随后接种 PCV13 或 PPV23 的免疫反应。相反,PPV23 则会减弱后续 PCV13 的免疫反应。CAPiTA 证明 PCV13 对 VT-IPD 和 VT-CAP 至少有五年的疗效。PCV13 临床开发项目为了解这种疫苗的成人特异性免疫反应提供了基础,并证实了共轭多糖技术比普通多糖技术更有优势。
{"title":"Adult indication 13-valent pneumococcal conjugate vaccine clinical development overview: formulation, safety, immunogenicity (dosing and sequence), coadministration, and efficacy.","authors":"Mark A Fletcher, Beate Schmoele-Thoma, Jelena Vojicic, Derek Daigle, Peter R Paradiso, Graciela Del Carmen Morales","doi":"10.1080/14760584.2024.2404636","DOIUrl":"10.1080/14760584.2024.2404636","url":null,"abstract":"<p><strong>Introduction: </strong>There was no 13-valent pneumococcal conjugate vaccine (PCV13) adult antibody concentration threshold regulatory criterion for licensure - unlike the pediatric indication; consequently, for the adult indication, PCV13 serotype-specific opsonophagocytic activity (OPA) geometric mean titer (GMT) values were immunobridged to the 23-valent plain polysaccharide vaccine (PPV23) to infer efficacy against invasive pneumococcal disease (IPD). Subsequently, a double-blind, randomized, controlled PCV13 efficacy trial (CAPiTA) was performed in community-living, older adults to confirm efficacy against vaccine-serotype IPD (VT-IPD) and establish efficacy against vaccine-serotype pneumococcal community-acquired pneumonia (VT-CAP).</p><p><strong>Areas covered: </strong>This article summarizes 31 publications from the PCV13 adult indication clinical development trials and other PCV13 clinical studies, organized by formulation, reactogenicity and safety, immunogenicity, coadministration, and clinical efficacy.</p><p><strong>Expert opinion: </strong>PCV13 had a favorable safety profile with an OPA response generally greater than PPV23 irrespective of age and of previous pneumococcal vaccination. PCV13 primed for enhanced immune responses with subsequent PCV13 or PPV23 dosing. Conversely, PPV23 was shown to blunt the response to subsequent PCV13. CAPiTA demonstrated PCV13 efficacy for at least five years against both VT-IPD and VT-CAP. The PCV13 clinical development program provided fundamental insights into this vaccine's adult-specific immune responses and confirmed the advantages of conjugate over plain polysaccharide technology.</p>","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"944-957"},"PeriodicalIF":5.5,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142282790","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Modeling the potential public health impact of different vaccination strategies with an adapted vaccine in South Africa. 模拟南非使用改良疫苗的不同接种策略对公共卫生的潜在影响。
IF 5.5 3区 医学 Q1 IMMUNOLOGY Pub Date : 2024-01-01 Epub Date: 2024-08-28 DOI: 10.1080/14760584.2024.2396091
Nadine Al Akoury, Julia Spinardi, Hammam Haridy, Ntsiki Molefe-Osman, Noko Mphahlele, Carlos Fernando Mendoza, Jingyan Yang, Elena Aruffo, Moe H Kyaw, Ben Yarnoff

Background: COVID-19 vaccines adapted to newly emerging circulating variants are necessary to better protect the population due to the evolving nature of the SARS-CoV-2 virus.

Research design and methods: The South African population was stratified by age and risk (defined by comorbidities such as diabetes, obesity, smoking, cancer, and asthma), and HIV status. The outcomes of different vaccination strategies based on age, risk, and HIV status were estimated using a Markov-decision tree model based on age-specific inputs derived from the literature and South African surveillance data.

Results: Vaccinating older adults and those with comorbidities was estimated to avert 111,179 infections 18,281 hospitalizations, and 3,868 deaths, resulting in savings of ZAR 1,260 million (USD 67 million) and ZAR 3,205 million (USD 170 million) in direct and indirect costs, respectively. Similar results were obtained when considering strategies targeting older adults and the HIV population. Expanding vaccination to 75% of the standard-risk population prevented more infections (401%), hospitalizations (167%), and deaths (67%) and increased the direct (232%) and indirect (455%) cost savings compared to the base case.

Conclusions: Implementing widespread vaccination strategies that utilize a vaccine adapted to the prevailing circulating variant in South Africa would result in significant public health and economic gains.

背景:由于 SARS-CoV-2 病毒不断演变,有必要根据新出现的循环变异株接种 COVID-19 疫苗,以更好地保护人群:对南非人口按年龄和风险(根据糖尿病、肥胖症、吸烟、癌症和哮喘等合并症定义)以及艾滋病毒感染状况进行了分层。根据文献和南非监测数据得出的特定年龄输入值,使用马尔可夫决策树模型估算了基于年龄、风险和 HIV 感染状况的不同疫苗接种策略的结果:据估计,为老年人和合并症患者接种疫苗可避免 111,179 例感染、18,281 例住院和 3,868 例死亡,从而分别节省 12.6 亿南非兰特(6,700 万美元)和 32.05 亿南非兰特(1.7 亿美元)的直接和间接成本。在考虑针对老年人和艾滋病毒感染者的战略时,也取得了类似的结果。与基础案例相比,将疫苗接种扩大到 75% 的标准风险人群可预防更多的感染(401%)、住院(167%)和死亡(67%),并增加直接成本节约(232%)和间接成本节约(455%):实施广泛的疫苗接种策略,利用适应南非流行变异株的疫苗,将带来显著的公共卫生和经济收益。
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引用次数: 0
The potential public health impact of the respiratory syncytial virus prefusion F protein vaccine in people aged ≥60 years in Japan: results of a Markov model analysis. 呼吸道合胞病毒预融合 F 蛋白疫苗对日本≥60 岁人群的潜在公共卫生影响:马尔可夫模型分析结果。
IF 6.2 3区 医学 Q1 IMMUNOLOGY Pub Date : 2024-01-01 Epub Date: 2024-03-01 DOI: 10.1080/14760584.2024.2323128
Daisuke Kurai, Akiko Mizukami, Victor Preckler, Frederik Verelst, Daniel Molnar, Taizo Matsuki, Yufan Ho, Ataru Igarashi

Background: Respiratory syncytial virus (RSV), a common respiratory pathogen, can lead to severe symptoms, especially in older adults (OA). A recently developed RSV prefusion F protein (RSVPreF3 OA) vaccine confers high protection against RSV lower respiratory tract disease (LRTD) over two full RSV seasons. The aim of this study was to assess the potential public health impact of RSVPreF3 OA vaccination in the Japanese OA population.

Research design and methods: A static Markov model was used to estimate the number of symptomatic RSV cases, hospitalizations and deaths in the Japanese population aged ≥ 60 years over a 3-year time horizon. Japan-specific RSV epidemiology and healthcare resource use parameters were used; vaccine efficacy was derived from a phase 3 randomized study (AReSVi-006, NCT04886596). Vaccination coverage was set to 50%.

Results: Without vaccination, >5 million RSV acute respiratory illness (ARI) would occur (2.5 million LRTD and 2.8 million upper respiratory tract infections) leading to ~ 3.5 million outpatient visits, >534,000 hospitalizations and ~ 25,500 RSV-related deaths over 3 years. Vaccination could prevent > 1 million RSV-ARI cases, 728,000 outpatient visits, 143,000 hospitalizations and 6,840 RSV-related deaths.

Conclusions: RSVPreF3 OA vaccination is projected to have a substantial public health impact by reducing RSV-related morbidity and mortality in the OA population.

背景:呼吸道合胞病毒(RSV)是一种常见的呼吸道病原体,可导致严重症状,尤其是在老年人(OA)中。最近开发的一种 RSV 预融合 F 蛋白(RSVPreF3 OA)疫苗可在两个完整的 RSV 季节中对 RSV 下呼吸道疾病(LRTD)提供高度保护。本研究的目的是评估在日本 OA 群体中接种 RSVPreF3 OA 疫苗对公共卫生的潜在影响:研究设计和方法:采用静态马尔可夫模型估算日本年龄≥ 60 岁人群在 3 年时间跨度内有症状的 RSV 病例、住院和死亡人数。使用了日本特有的 RSV 流行病学和医疗资源使用参数;疫苗疗效来自一项 3 期随机研究 (AReSVi-006, NCT04886596)。疫苗接种覆盖率设定为 50%:结果:如果不接种疫苗,3 年内将发生超过 500 万例 RSV 急性呼吸道疾病(ARI)(250 万例 LRTD 和 280 万例上呼吸道感染),导致约 350 万人次门诊就诊、超过 53.4 万人次住院治疗以及约 2.55 万人次 RSV 相关死亡。接种疫苗可预防 > 100 万例 RSV-ARI 病例、728,000 次门诊就诊、143,000 次住院治疗和 6,840 例 RSV 相关死亡:预计 RSVPreF3 OA 疫苗接种可降低 OA 人口中 RSV 相关的发病率和死亡率,从而对公共卫生产生重大影响。
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引用次数: 0
Safety and immunogenicity of the SARS-CoV-2 LYB001 RBD-based VLP vaccine (CHO cell) phase 1 in Chinese adults: a randomized, double-blind, positive-parallel-controlled study. 中国成年人接种基于 LYB001 RBD 的 SARS-CoV-2 VLP 疫苗(CHO 细胞)第一阶段的安全性和免疫原性:随机、双盲、阳性平行对照研究。
IF 6.2 3区 医学 Q1 IMMUNOLOGY Pub Date : 2024-01-01 Epub Date: 2024-05-02 DOI: 10.1080/14760584.2024.2337051
Rong Tang, Ying Zeng, Yu Zhou, Qi Liang, Wei Kang, Zhonghua Yang, Xiaoxiang Zheng, Xia Zang, Hongxing Pan, Jing Jin, Fengcai Zhu

Background: Vaccination remains the cornerstone of defense against COVID-19 globally. This study aims to assess the safety and immunogenicity profile of innovative vaccines LYB001.

Research design and methods: This was a randomized, double-blind, parallel-controlled trial, in 100 healthy Chinese adults (21 to 72 years old). Three doses of 30 or 60 µg of SARS-CoV-2 RBD-based VLP vaccine (LYB001), or the SARS-CoV-2 RBD-based protein subunit vaccine (ZF2001, control group) were administered with a 28-day interval. Differences in the incidence of adverse events (AEs) and indicators of humoral and cellular immunity among the different groups were measured.

Results: No severe adverse events were confirmed to be vaccine-related, and there was no significant difference in the rate of adverse events between the LYB001 and control group or the age subgroups (p > 0.05). The LYB001 groups had significantly higher or comparable levels of seroconversion rates, neutralization antibody, S protein-binding antibody, and cellular immunity after whole vaccination than the control group.

Conclusions: Our findings support that LYB001 developed on the VLP platform is safe and well tolerated with favorable immunogenicity for fundamental vaccination in healthy adults. Therefore, further larger-scale clinical studies are warranted.

Trial registration: This trial was registered with ClinicalTrials.gov (NCT05552573).

背景:疫苗接种仍是全球防御 COVID-19 的基石。本研究旨在评估创新疫苗 LYB001 的安全性和免疫原性:这是一项随机、双盲、平行对照试验,对象为 100 名健康的中国成年人(21 至 72 岁)。试验采用随机、双盲、平行对照的方法,给 100 名健康的中国成年人(21 至 72 岁)接种了三剂 30 或 60 µg 的基于 SARS-CoV-2 RBD 的 VLP 疫苗(LYB001),或基于 SARS-CoV-2 RBD 的蛋白亚单位疫苗(ZF2001,对照组),每剂间隔 28 天。测量了不同组间不良事件(AEs)发生率以及体液免疫和细胞免疫指标的差异:结果:没有严重不良事件被证实与疫苗有关,LYB001组与对照组或各年龄亚组之间的不良事件发生率没有显著差异(P > 0.05)。LYB001组在全程接种后的血清转换率、中和抗体、S蛋白结合抗体和细胞免疫水平明显高于对照组,或与之相当:我们的研究结果表明,基于 VLP 平台开发的 LYB001 安全、耐受性好、免疫原性良好,可用于健康成人的基础疫苗接种。因此,有必要进一步开展更大规模的临床研究:本试验已在 ClinicalTrials.gov (NCT05552573) 注册。
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引用次数: 0
Research progress on the quality control of mRNA vaccines. mRNA 疫苗质量控制的研究进展。
IF 6.2 3区 医学 Q1 IMMUNOLOGY Pub Date : 2024-01-01 Epub Date: 2024-05-24 DOI: 10.1080/14760584.2024.2354251
Chaoying Hu, Yu Bai, Jianyang Liu, Yiping Wang, Qian He, Xuanxuan Zhang, Feiran Cheng, Miao Xu, Qunying Mao, Zhenglun Liang

Introduction: The mRNA vaccine technologies have progressed rapidly in recent years. The COVID-19 pandemic has accelerated the application of mRNA vaccines, with research and development and clinical trials underway for many vaccines. Application of the quality by design (QbD) framework to mRNA vaccine development and establishing standardized quality control protocols for mRNA vaccines are essential for the continued development of high-quality mRNA vaccines.

Areas covered: mRNA vaccines include linear mRNA, self-amplifying mRNA, and circular RNA vaccines. This article summarizes the progress of research on quality control of these three types of vaccines and presents associated challenges and considerations.

Expert opinion: Although there has been rapid progress in research on linear mRNA vaccines, their degradation patterns remain unclear. In addition, standardized assays for key impurities, such as residual dsRNA and T7 RNA polymerase, are still lacking. For self-amplifying mRNA vaccines, a key focus should be control of stability in vivo and in vitro. For circular RNA vaccines, standardized assays, and reference standards for determining degree of circularization should be established and optimized.

简介近年来,mRNA 疫苗技术发展迅速。COVID-19 大流行加速了 mRNA 疫苗的应用,许多疫苗的研发和临床试验正在进行中。将质量设计(QbD)框架应用于 mRNA 疫苗的开发,并建立标准化的 mRNA 疫苗质量控制规程,对于持续开发高质量的 mRNA 疫苗至关重要。本文总结了这三类疫苗质量控制的研究进展,并提出了相关的挑战和注意事项:尽管线性 mRNA 疫苗的研究进展迅速,但其降解模式仍不明确。此外,对关键杂质(如残留的 dsRNA 和 T7 RNA 聚合酶)的标准化检测仍然缺乏。对于自扩增 mRNA 疫苗来说,重点应放在体内和体外稳定性的控制上。对于环状 RNA 疫苗,应建立并优化用于确定环化程度的标准化检测方法和参考标准。
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引用次数: 0
Lessons from a decade of adult vaccine rollout in low- and middle-income countries: a scoping review. 中低收入国家成人疫苗推广十年的经验教训:范围综述。
IF 5.5 3区 医学 Q1 IMMUNOLOGY Pub Date : 2024-01-01 Epub Date: 2024-07-10 DOI: 10.1080/14760584.2024.2375329
Amelia K Gerste, Arman Majidulla, Anurima Baidya, Onimitein Georgewill, Andrea N DeLuca, Puck T Pelzer, Michelle M Gill, Degu Jerene, Joeri S Buis, Andrew D Kerkhoff, Rupali J Limaye

Introduction: The historical focus of vaccines on child health coupled with the advent of novel vaccines targeting adult populations necessitates exploring strategies for adult vaccine implementation.

Areas covered: This scoping review extracts insights from the past decade's experiences introducing adult vaccines in low- and middle-income countries. Among 25 papers reviewed, 19 focused on oral cholera vaccine, 2 on Meningococcal A vaccines, 2 on tetanus toxoid vaccine, 1 on typhoid vaccine, and 1 on Ebola vaccine. Aligned with WHO's Global Framework for New TB Vaccines for Adults and Adolescents, our findings center on vaccine availability, accessibility, and acceptance.

Expert opinion: Availability findings underscore the importance of understanding disease burden for prioritization, multi-sectoral collaboration during planning, and strategic resource allocation and coordination. Accessibility results highlight the benefits of leveraging existing health infrastructure and adequately training healthcare workers, and contextually tailoring vaccine delivery approaches to reach challenging sub-groups like working male adults. Central to fostering acceptance, resonant sensitization, and communication campaigns engaging the communities and utilizing trusted local leaders countered rumors and increased awareness and uptake. As we approach the introduction of a new adult TB vaccine, insights from this review equips decision-makers with key evidence-based recommendations to support successful and equitable vaccinations targeting adults.

简介:疫苗历来以儿童健康为重点,随着针对成人的新型疫苗的出现,有必要探索成人疫苗的实施策略:本范围界定综述从过去十年中低收入国家引入成人疫苗的经验中汲取启示。在 25 篇综述论文中,19 篇侧重于口服霍乱疫苗,2 篇侧重于 A 型脑膜炎球菌疫苗,2 篇侧重于破伤风类毒素疫苗,1 篇侧重于伤寒疫苗,1 篇侧重于埃博拉疫苗。根据世界卫生组织的《成人和青少年结核病新疫苗全球框架》,我们的研究结果主要集中在疫苗的可用性、可及性和可接受性方面:可用性研究结果强调了了解疾病负担对于确定优先次序、规划期间的多部门合作以及战略资源分配和协调的重要性。可及性结果突出了利用现有卫生基础设施和充分培训医疗工作者的益处,以及根据具体情况调整疫苗接种方法以覆盖具有挑战性的亚群体(如工作的男性成年人)的益处。促进接受度的关键在于,让社区参与进来并利用值得信赖的当地领导人开展有影响力的宣传和交流活动,从而消除谣言,提高认知度和接受率。在我们即将引入新的成人结核病疫苗之际,本综述中的见解为决策者提供了关键的循证建议,以支持针对成人的成功、公平的疫苗接种。
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Expert Review of Vaccines
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