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Combatting infectious diarrhea: innovations in treatment and vaccination strategies. 防治传染性腹泻:治疗和疫苗接种策略的创新。
IF 6.2 3区 医学 Q1 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2024-01-01 Epub Date: 2024-02-19 DOI: 10.1080/14760584.2023.2295015
Vivek P Chavda, Suneetha Vuppu, Toshika Mishra, Sathvika Kamaraj, Nikita Sharma, Swati Punetha, Anand Sairam, Dixa Vaghela, Narges Dargahi, Vasso Apostolopoulos

Introduction: The escalating prevalence of infectious diseases is an important cause of concern in society. Particularly in several developing countries, infectious diarrhea poses a major problem, with a high fatality rate, especially among young children. The condition is divided into four classes, namely, acute diarrhea, invasive diarrhea, acute bloody diarrhea, and chronic diarrhea. Various pathogenic agents, such as bacteria, viruses, protozoans, and helminths, contribute to the onset of this condition.

Areas covered: The review discusses the scenario of infectious diarrhea, the prevalent types, as well as approaches to management including preventive, therapeutic, and vaccination strategies. The vaccination techniques are extensively discussed including the available vaccines, their advantages as well as limitations.

Expert opinion: There are several approaches available to develop new-improved vaccines. In addition, route of immunization is important and aerosols/nasal sprays, oral route, skin patches, powders, and liquid jets to minimize needles can be used. Plant-based vaccines, such as rice, might save packing and refrigeration costs by being long-lasting, non-refrigerable, and immunogenic. Future research should utilize predetermined PCR testing intervals and symptom monitoring to identify persistent pathogens after therapy and symptom remission.

导言:传染病发病率的不断上升是社会关注的一个重要问题。特别是在一些发展中国家,感染性腹泻是一个主要问题,死亡率很高,尤其是在幼儿中。这种疾病分为四类,即急性腹泻、侵袭性腹泻、急性血性腹泻和慢性腹泻。细菌、病毒、原生动物和蠕虫等各种病原体都是导致这种疾病发生的原因:综述讨论了感染性腹泻的发病情况、流行类型以及治疗方法,包括预防、治疗和疫苗接种策略。还广泛讨论了疫苗接种技术,包括现有疫苗、其优势和局限性:有几种方法可用于开发新的改良疫苗。此外,免疫途径也很重要,可使用气雾剂/鼻腔喷雾剂、口服途径、皮肤贴剂、粉剂和液体喷射器,以尽量减少针头。以大米等植物为原料的疫苗可能因其持久性、非冷藏性和免疫原性而节省包装和冷藏成本。未来的研究应利用预定的 PCR 检测时间间隔和症状监测来确定治疗和症状缓解后的持续病原体。
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引用次数: 0
Impact of rotavirus vaccination on diarrheal disease burden of children in South America. 轮状病毒疫苗接种对南美洲儿童腹泻疾病负担的影响。
IF 6.2 3区 医学 Q1 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2024-01-01 Epub Date: 2024-05-31 DOI: 10.1080/14760584.2024.2360212
Tanmoy Bose, Ray Borrow, Peter D Arkwright

Introduction: Rotavirus is a leading cause of severe diarrheal disease and death in children under five years of age worldwide. Vaccination is one of the most important public health interventions to reduce this significant burden.

Areas covered: This literature review examined vaccination coverage, hospitalization rate, mortality, genotypic distribution, immunogenicity, cost-effectiveness, and risk versus benefit of rotavirus vaccination in children in South America. Nine out of twelve countries in South America currently include a rotavirus vaccine in their national immunization program with coverage rates in 2022 above 90%.

Expert opinion: Introduction of the rotavirus vaccination has led to a marked reduction in hospitalizations and deaths from diarrheal diseases in children under 5 years, particularly infants under 1 year, in several South American countries. In Brazil, hospitalizations decreased by 59% and deaths by 21% (30-38% in infants). In Peru, hospitalizations in infants fell by 46% and deaths by 37% (56% in infants). Overall, data suggest that rotavirus vaccination has reduced rotavirus deaths by 15-50% in various South American countries. There is some evidence that immunity wanes after the age of 1-year old. Ongoing surveillance of vaccine coverage and changes in morbidity and mortality is important to maximize protection against this disease.

导言:轮状病毒是导致全球五岁以下儿童严重腹泻和死亡的主要原因。接种疫苗是减少这一重大负担的最重要公共卫生干预措施之一:本文献综述研究了南美洲儿童轮状病毒疫苗接种的覆盖率、住院率、死亡率、基因型分布、免疫原性、成本效益以及风险与收益的比较。目前,南美洲 12 个国家中有 9 个将轮状病毒疫苗纳入国家免疫计划,2022 年的覆盖率超过 90%:在一些南美国家,轮状病毒疫苗接种后,5 岁以下儿童(尤其是 1 岁以下婴儿)因腹泻疾病住院和死亡的人数明显减少。在巴西,住院人数减少了 59%,死亡人数减少了 21%(婴儿减少了 30-38%)。在秘鲁,婴儿住院率下降了 46%,死亡率下降了 37%(婴儿为 56%)。总体而言,数据表明,在南美各国,轮状病毒疫苗接种使轮状病毒死亡人数减少了 15-50%。有证据表明,1 岁以后免疫力会减弱。持续监测疫苗覆盖率以及发病率和死亡率的变化对于最大限度地预防这种疾病非常重要。
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引用次数: 0
Potential serotype-specific effectiveness against IPD of pneumococcal conjugate vaccines V114 and PCV20 in children given a 2+1 dosing regimen. 肺炎球菌结合疫苗 V114 和 PCV20 在儿童中对 IPD 的潜在血清型特异性效果,采用 2+1 给药方案。
IF 6.2 3区 医学 Q1 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2024-01-01 Epub Date: 2024-04-09 DOI: 10.1080/14760584.2024.2335323
Josiah Ryman, Jeffrey R Sachs, Natalie Banniettis, Thomas Weiss, Maurice Ahsman, Ka Lai Yee, Jessica Weaver

Background: Next generation, higher valency pneumococcal conjugate vaccines (PCVs) are assessed and licensed by comparing the immune response across serotypes shared with the PCVs that are standard of care for prevention of pneumococcal disease.

Methods: Using a previously qualified method we predicted the serotype-specific vaccine effectiveness (VE) against invasive pneumococcal disease of V114 and PCV20 for the serotypes shared with PCV13 in an EU, Russian, and Australian pediatric population that is recommended to receive a 2 + 1 dosing regimen.

Results: The estimated protective antibody concentrations ranged from 0.03 (serotype 23F) to 1.49 µg/mL (serotype 19F). Predicted VE values for V114 ranged from 79% (serotype 5) to 100% (serotype 23F). V114 had comparable effectiveness to PCV13 for all but one of shared serotypes, with predicted higher effectiveness (in V114) against serotype 3 (93% vs. 65%). Predicted VE values for PCV20 ranged from 47% (serotype 3) to 91% (serotype 14). PCV20 predicted VE was lower than PCV13's for serotypes 4, 19F, 23F, 1, 3, 5, 6A, 7F, and 19A.

Conclusions: Predicted serotype-specific VE values suggest that, with a 2 + 1 dosing regimen, V114 will have greater effectiveness than PCV20 against PCV13 serotypes, particularly for the still-prevalent serotype 3. Real-world VE studies will ultimately provide clarity on the effectiveness of novel PCVs and support further confidence in and/or improvements to modeling efforts.

背景:通过比较与预防肺炎球菌疾病的标准 PCV 共享的血清型的免疫反应来评估和许可下一代更高价肺炎球菌结合疫苗 (PCV):方法:我们使用之前获得认证的方法预测了 V114 和 PCV20 的血清型特异性疫苗预防侵袭性肺炎球菌疾病的有效性(VE),这些血清型与建议接受 2+1 给药方案的欧盟、俄罗斯和澳大利亚儿科人群中的 PCV13 共享:估计的保护性抗体浓度从 0.03(血清型 23F)到 1.49 µg/mL(血清型 19F)不等。V114的预测VE值从79%(血清型5)到100%(血清型23F)不等。除一种血清型外,V114 与 PCV13 对所有共用血清型的有效性相当,而 V114 对血清型 3 的预测有效性更高(93% 对 65%)。PCV20 的预测 VE 值从 47%(血清 3 型)到 91%(血清 14 型)不等。PCV20对血清型4、19F、23F、1、3、5、6A、7F和19A的预测VE值低于PCV13:预测的血清型特异性VE值表明,采用2+1给药方案,V114对PCV13血清型的有效性将高于PCV20,尤其是对仍然流行的血清型3。真实世界的 VE 研究最终将明确新型 PCV 的有效性,并进一步增强人们对建模工作的信心和/或改进建模工作。
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引用次数: 0
Past, present, and future policy considerations regarding meningococcal vaccination in the United States. 美国脑膜炎球菌疫苗接种的过去、现在和未来政策考虑。
IF 5.5 3区 医学 Q1 IMMUNOLOGY Pub Date : 2024-01-01 Epub Date: 2024-09-11 DOI: 10.1080/14760584.2024.2397705
Diana E Clements, Tosin Olaiya, Cindy Burman, Oscar Herrera-Restrepo, Woo-Yun Sohn, Temi Folaranmi, Victoria Abbing-Karahagopian, Gary S Marshall, James H Conway

Introduction: In 2005, the United States Advisory Committee on Immunization Practices (ACIP) recommended routine vaccination against invasive meningococcal disease (IMD) caused by serogroups A, C, W, and Y (MenACWY) for all 11-12-year-olds, as well as 2-10-year-olds at high risk. In 2010, a booster dose was recommended for all 16-year-olds, as well as for high-risk patients every 3-5 years. In 2015, optional (as opposed to routine) vaccination against meningococcal serogroup B (MenB) at the preferred age of 16-18 years was recommended (Category B, later changed to shared clinical decision-making). In 2023, a vaccine (MenABCWY) against the five serogroups primarily responsible for IMD in the U.S. became available.

Areas covered: This review summarizes the evolution of public policy that led to each milestone vaccine recommendation, reviews epidemiologic data published following the recommendations, and discusses the current state of meningococcal immunization policy.

Expert opinion: The use of MenABCWY has the potential to consolidate policy, improve coverage rates for the five serogroups, address disparities in vaccination coverage, and simplify vaccine delivery.

导言:2005 年,美国免疫实践咨询委员会 (ACIP) 建议为所有 11-12 岁的青少年以及 2-10 岁的高危人群常规接种由 A、C、W 和 Y 血清群 (MenACWY) 引起的侵袭性脑膜炎球菌病 (IMD) 疫苗。2010 年,建议所有 16 岁儿童以及高危患者每 3-5 年加强一次疫苗接种。2015 年,建议在首选年龄 16-18 岁接种脑膜炎球菌血清 B 群 (MenB) 疫苗(B 类,后改为共同临床决策)。2023 年,针对 5 个主要导致美国 IMD 的血清群的疫苗(MenABCWY)上市:本综述总结了促成每项里程碑式疫苗建议的公共政策演变,回顾了建议提出后公布的流行病学数据,并讨论了脑膜炎球菌免疫接种政策的现状:专家意见:使用 MenABCWY 有可能整合政策,提高 5 个血清群的覆盖率,解决疫苗接种覆盖率不均的问题,并简化疫苗接种过程。
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引用次数: 0
Modelling the Potential Public Health Impact of Different COVID-19 Vaccination Strategies with an Adapted Vaccine in Singapore. 在新加坡使用适应疫苗对不同COVID-19疫苗接种策略的潜在公共卫生影响进行建模
IF 6.2 3区 医学 Q1 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2024-01-01 Epub Date: 2023-12-12 DOI: 10.1080/14760584.2023.2290931
Karan Thakkar, Julia Spinardi, Moe H Kyaw, Jingyan Yang, Carlos Fernando Mendoza, Egemen Ozbilgili, Bulent Taysi, Josie Dodd, Ben Yarnoff, Helen M Oh

Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causing COVID-19 has been a dynamically changing virus, requiring the development of adapted vaccines. This study estimated the potential public health impact alternative vaccination strategies for COVID-19 in Singapore.

Research design and methods: The outcomes of alternative vaccination strategies with a future adapted vaccine were estimated using a combined Markov decision tree model. The population was stratified by high- and standard-risk. Using age-specific inputs informed by local surveillance data and published sources, the model estimated health (case numbers, hospitalizations, and deaths) and economic (medical costs and productivity losses) outcomes in different age and risk subpopulations.

Results: Booster vaccination in only the elderly and high-risk subpopulation was estimated to avert 278,614 cases 21,558 hospitalizations, 239 deaths, Singapore dollars (SGD) 277 million in direct medical costs, and SGD 684 million in indirect medical costs. These benefits increased as vaccination was expanded to other subpopulations. Increasing the booster vaccination coverage to 75% of the standard-risk population averted more deaths (3%), hospitalizations (29%), infections (145%), direct costs (90%), and indirect costs (192%) compared to the base case.

Conclusions: Broader vaccination strategies using an adapted booster vaccine could have substantial public health and economic impact in Singapore.

背景:引起COVID-19的严重急性呼吸综合征冠状病毒2 (SARS-CoV-2)是一种动态变化的病毒,需要开发适应疫苗。本研究估计了新加坡COVID-19替代疫苗接种策略的潜在公共卫生影响。研究设计和方法:使用联合马尔可夫决策树模型估计未来适应疫苗的替代疫苗接种策略的结果。人群按高风险和标准风险分层。该模型利用当地监测数据和公开来源提供的特定年龄输入,估计了不同年龄和风险亚人群的健康(病例数、住院和死亡)和经济(医疗费用和生产力损失)结果。结果:仅在老年人和高危亚人群中加强疫苗接种估计可避免278,614例病例,21,558例住院,239例死亡,直接医疗费用为2.77亿新元,间接医疗费用为6.84亿新元。随着疫苗接种扩展到其他亚群,这些益处也会增加。与基本情况相比,将加强疫苗接种覆盖率提高到标准风险人群的75%可避免更多的死亡(3%)、住院(29%)、感染(145%)、直接费用(90%)和间接费用(192%)。结论:在新加坡,使用适应性加强疫苗的更广泛的疫苗接种策略可能对公共卫生和经济产生重大影响。
{"title":"Modelling the Potential Public Health Impact of Different COVID-19 Vaccination Strategies with an Adapted Vaccine in Singapore.","authors":"Karan Thakkar, Julia Spinardi, Moe H Kyaw, Jingyan Yang, Carlos Fernando Mendoza, Egemen Ozbilgili, Bulent Taysi, Josie Dodd, Ben Yarnoff, Helen M Oh","doi":"10.1080/14760584.2023.2290931","DOIUrl":"10.1080/14760584.2023.2290931","url":null,"abstract":"<p><strong>Background: </strong>Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causing COVID-19 has been a dynamically changing virus, requiring the development of adapted vaccines. This study estimated the potential public health impact alternative vaccination strategies for COVID-19 in Singapore.</p><p><strong>Research design and methods: </strong>The outcomes of alternative vaccination strategies with a future adapted vaccine were estimated using a combined Markov decision tree model. The population was stratified by high- and standard-risk. Using age-specific inputs informed by local surveillance data and published sources, the model estimated health (case numbers, hospitalizations, and deaths) and economic (medical costs and productivity losses) outcomes in different age and risk subpopulations.</p><p><strong>Results: </strong>Booster vaccination in only the elderly and high-risk subpopulation was estimated to avert 278,614 cases 21,558 hospitalizations, 239 deaths, Singapore dollars (SGD) 277 million in direct medical costs, and SGD 684 million in indirect medical costs. These benefits increased as vaccination was expanded to other subpopulations. Increasing the booster vaccination coverage to 75% of the standard-risk population averted more deaths (3%), hospitalizations (29%), infections (145%), direct costs (90%), and indirect costs (192%) compared to the base case.</p><p><strong>Conclusions: </strong>Broader vaccination strategies using an adapted booster vaccine could have substantial public health and economic impact in Singapore.</p>","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138477188","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
Progress toward the development of Lassa vaccines. 拉沙病毒疫苗研制的进展。
IF 6.2 3区 医学 Q1 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2024-01-01 Epub Date: 2023-12-11 DOI: 10.1080/14760584.2023.2290683
Hinh Ly
{"title":"Progress toward the development of Lassa vaccines.","authors":"Hinh Ly","doi":"10.1080/14760584.2023.2290683","DOIUrl":"10.1080/14760584.2023.2290683","url":null,"abstract":"","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10757453/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138477189","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Assessment of the comprehensiveness of paediatric national immunisation programmes in Europe: expert validation and future perspectives. 评估欧洲儿科国家免疫计划的全面性:专家论证和未来展望。
IF 6.2 3区 医学 Q1 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2024-01-01 Epub Date: 2024-03-01 DOI: 10.1080/14760584.2024.2324939
Ugne Sabale, Janice Murtagh, James Cochrane, Danielle Riley, Richard Perry, Louise Heron, Paolo Bonanni, Jose Navarro Alonso, Juhani Eskola, Valerie Laigle

Background: The breadth of protection of National Immunisation Programmes (NIPs) across Europe varies, however, this has not been assessed within published literature. Therefore, a framework was developed to assess the comprehensiveness of pediatric NIPs in Europe. This study aimed to validate and further develop criteria used to cluster countries into three tiers.

Research design and methods: Independent Europe-based experts (n = 23) in the field of pediatric vaccination were invited to participate in a double-blinded modified Delphi panel, with two online survey rounds and a virtual consensus meeting. Consensus was defined as ≥ 80% of experts rating their agreement/disagreement on a 9-point Likert scale.

Results: The number of preventable diseases covered by an NIP, simplification of the vaccination calendar, strengthened protection by increasing serotype, degree of funding and epidemiological factors were considered key concepts for consideration of the comprehensiveness of pediatric NIPs in Europe. Experts highlighted that the framework should be extended to include adolescent vaccines and populations up to 18 years of age. Consensus regarding further amendments to the framework was also reached.

Conclusions: This Delphi panel validated a framework to assess the comprehensiveness of European NIPs. The framework can be used to facilitate discussions to help countries improve and expand the breadth of protection provided by their NIP.

背景:欧洲各国的国家免疫计划(NIPs)的保护范围各不相同,但已发表的文献尚未对此进行评估。因此,我们制定了一个框架来评估欧洲儿科国家免疫计划的全面性。本研究旨在验证并进一步发展用于将各国划分为三个等级的标准:邀请欧洲儿科疫苗接种领域的独立专家(n = 23)参加双盲改良德尔菲小组,包括两轮在线调查和一次虚拟共识会议。共识的定义是:≥ 80% 的专家在 9 点李克特量表上表示同意/不同意:结果:国家免疫计划涵盖的可预防疾病数量、疫苗接种日程的简化、通过增加血清型加强保护、资助程度和流行病学因素被认为是考虑欧洲儿科国家免疫计划全面性的关键概念。专家们强调,该框架应扩展至包括青少年疫苗和 18 岁以下人群。专家们还就进一步修订该框架达成了共识:德尔菲小组验证了评估欧洲国家免疫计划全面性的框架。该框架可用于促进讨论,帮助各国改进和扩大其国家免疫计划提供的保护范围。
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引用次数: 0
Effectiveness of primary series, first, and second booster vaccination of monovalent mRNA COVID-19 vaccines against symptomatic SARS-CoV-2 infections and severe diseases during the SARS-CoV-2 omicron BA.5 epidemic in Japan: vaccine effectiveness real-time surveillance for SARS-CoV-2 (VERSUS). 在日本 SARS-CoV-2 omicron BA.5 流行期间,接种单价 mRNA COVID-19 疫苗初级系列、第一次和第二次加强接种对无症状 SARS-CoV-2 感染和严重疾病的有效性:SARS-CoV-2 疫苗有效性实时监测 (VERSUS)。
IF 6.2 3区 医学 Q1 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2024-01-01 Epub Date: 2024-02-08 DOI: 10.1080/14760584.2024.2310807
Haruka Maeda, Nobuo Saito, Ataru Igarashi, Masayuki Ishida, Mayumi Terada, Shingo Masuda, Ryosuke Osawa, Naoto Hosokawa, Kei Nakashima, Hiroshi Kamura, Haruki Imura, Hiroki Inoue, Suguru Matsuzaka, Yukihiro Sugimoto, Osamu Kuwamitsu, Iori Motohashi, Toru Morikawa, Rentaro Oda, Yuiko Hoshina, Takashi Matono, Osamu Teshigahara, Eiichiro Sando, Sadaharu Asami, Satoshi Kudo, Noboru Akizuki, Yoshikazu Muto, Tomoichiro Hayakawa, Tomoo Kishaba, Yasuji Ohara, Yoshinao Kubo, Motoi Suzuki, Konosuke Morimoto

Background: This study aimed to evaluate VE of primary, first, and second booster ancestral-strain monovalent mRNA COVID-19 vaccination against symptomatic infections and severe diseases in Japan.

Methods: We conducted a test-negative case-control study. We included medically attended episodes and hospitalizations involving individuals aged 16 with signs and symptoms from July to November 2022, when Omicron BA.5 was dominant nationwide. To evaluate VE, we calculated adjusted ORs of vaccination among test-positive versus test-negative individuals using a mixed-effects logistic regression.

Results: For VE against symptomatic infections among individuals aged 16 to 59, VE of primary vaccination at > 180 days was 26.1% (95% CI: 10.6-38.8%); VE of the first booster was 58.5% (48.4-66.7%) at 90 days, decreasing to 41.1% (29.5-50.8%) at 91 to 180 days. For individuals aged 60, VE of the first booster was 42.8% (1.7-66.7%) at 90 days, dropping to 15.4% (-25.9-43.2%) at 91 to 180 days, and then increasing to 44.0% (16.4-62.5%) after the second booster. For VE against severe diseases, VE of the first and second booster was 77.3% (61.2-86.7%) at 90 days and 55.9% (23.4-74.6%) afterward.

Conclusion: mRNA booster vaccination provided moderate protection against symptomatic infections and high-level protection against severe diseases during the BA.5 epidemic in Japan.

背景:本研究旨在评估在日本接种祖传株单价 mRNA COVID-19 疫苗对无症状感染和严重疾病的预防效果:我们进行了一项试验阴性病例对照研究。我们纳入了 2022 年 7 月至 11 月(当时 Omicron BA.5 在全国占主导地位)有症状和体征的年龄≥16 岁的人的就诊和住院病例。为了评估 VE,我们使用混合效应逻辑回归法计算了检测呈阳性者与检测呈阴性者接种疫苗的调整 OR:对于 16 至 59 岁人群的无症状感染 VE,大于 180 天的初次接种 VE 为 26.1%(95% CI:10.6-38.8%);≤90 天的首次加强接种 VE 为 58.5%(48.4-66.7%),91 至 180 天的 VE 降至 41.1%(29.5-50.8%)。对于年龄≥60 岁的人,第一次加强接种的 VE 在≤90 天时为 42.8%(1.7-66.7%),在 91 至 180 天时降至 15.4%(-25.9-43.2%),第二次加强接种后又增至 44.0%(16.4-62.5%)。结论:在日本 BA.5 疫情期间,接种 mRNA 强毒疫苗可对无症状感染提供中度保护,并对严重疾病提供高度保护。
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引用次数: 0
Immunogenicity and safety of boosting with a recombinant two-component SARS-CoV-2 vaccine: two randomized, parallel-controlled, phase 2 studies. 重组双组分 SARS-CoV-2 疫苗的免疫原性和安全性:两项随机、平行对照、2 期研究。
IF 6.2 3区 医学 Q1 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2024-01-01 Epub Date: 2024-04-02 DOI: 10.1080/14760584.2024.2334423
Abundio Balgos, Suad Hannawi, Wen-Li Chen, Alaa Abuquta, Linda Safeldin, Aala Hassan, Ahmad Alamadi, Louie Tirador, Anjuli May Jaen, Ralph Elvi Villalobos, Chen Mo, Zi-Jing Yue, Ying Ma, Qing-Shuang Wang, Ren-Du Wen, Zheng Yao, Jia-Ping Yu, Wen-Rong Yao, Jian-Hui Zhang, Kun-Xue Hong, Yong Liu, Jing-Xin Li

Background: Recombinant protein vaccines are vital for broad protection against SARS-CoV-2 variants. This study assessed ReCOV as a booster in two Phase 2 trials.

Research design and methods: Study-1 involved subjects were randomized (1:1:1) to receive 20 μg ReCOV, 40 μg ReCOV, or an inactivated vaccine (COVILO®) in the United Arab Emirates. Study-2 participating individuals were randomized (1:1:1) to receive 20 μg ReCOV (pilot batch, ReCOV HA), 20 μg ReCOV (commercial batch, ReCOV TC), or 30 μg BNT162b2 (COMIRNATY®) in the Philippines. The primary immunogenicity objectives was to compare the geometric mean titer (GMT) and seroconversion rate (SCR) of neutralizing antibodies induced by one ReCOV booster dose with those of inactivated vaccine and BNT162b2, respectively, at 14 days post-booster.

Results: Heterologous ReCOV booster doses were safe and induced comparable immune responses to inactivated vaccines and BNT162b2 against Omicron variants and the prototype. They showed significant advantages in cross-neutralization against multiple SARS-CoV-2 variants, surpassing inactivated vaccines and BNT162b2, with good immune persistence.

Conclusions: Heterologous ReCOV boosting was safe and effective, showing promise in combating COVID-19. The study highlights ReCOV's potential for enhanced protection, supported by strong cross-neutralization and immune persistence.

Clinical trial registration: Study-1, www.clinicaltrials.gov, identifier is NCT05323435; Study-2, www.clinicaltrials.gov, identifier is NCT05084989.

背景:重组蛋白疫苗在提供针对 SARS-CoV-2 变异株的广泛免疫保护方面发挥着至关重要的作用。本研究在两项随机、观察者盲法、主动对照的 2 期临床试验中评估了 ReCOV 作为加强剂量的安全性和免疫原性:在研究-1中,阿拉伯联合酋长国对接种过两剂或三剂COVID-19灭活疫苗的成人进行了随机分配(1:1:1),分别接种20 μg ReCOV、40 μg ReCOV或灭活疫苗(COVILO®)。研究-2涉及在菲律宾接种两剂COVID-19灭活疫苗的受试者,他们被随机(1:1:1)分配接种20微克ReCOV(试验批次,ReCOV HA)、20微克ReCOV(商业批次,ReCOV TC)或30微克BNT162b2(COMIRNATY®)。主要免疫原性目标是比较 ReCOV 与灭活疫苗和 BNT162b2 在加强剂量后 14 天分别诱导的 SARS-CoV-2 原型活病毒中和抗体的几何平均滴度 (GMT) 和血清转换率 (SCR):结果:异源加强剂量的 ReCOV 安全、耐受性良好,在既往接种过疫苗的成人中,针对 Omicron 变体和原型引起的免疫原性反应不劣于灭活疫苗和 BNT162b2。结果表明,该产品在针对多种 SARS-CoV-2 变异株的交叉中和活性方面具有明显优势,超过了灭活疫苗和 BNT162b2。此外,免疫持久性也很好:结论:使用 ReCOV 进行异源增强证明是安全有效的,对控制 COVID-19 的流行具有良好的效果。这项研究揭示了 ReCOV 在提供增强保护方面的巨大潜力,其强大的交叉中和活性和免疫持久性为其提供了支持:研究-1,www.clinicaltrials.gov,标识符为 NCT05323435;研究-2,www.clinicaltrials.gov,标识符为 NCT05084989。
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引用次数: 0
Cost-effectiveness analysis of adult pneumococcal conjugate vaccines for pneumococcal disease in Japan. 日本成人肺炎球菌结合疫苗治疗肺炎球菌疾病的成本效益分析。
IF 5.5 3区 医学 Q1 IMMUNOLOGY Pub Date : 2024-01-01 Epub Date: 2024-05-09 DOI: 10.1080/14760584.2024.2350246
Shigeki Nakamura, Masashi Mikami, Tomoyuki Hayamizu, Naohiro Yonemoto, Camille Moyon, Mark Gouldson, Catriona Crossan, Jeffrey Vietri, Kazumasa Kamei

Background: The 23-valent pneumococcal polysaccharide vaccine (PPSV23) is used in the Japanese National Immunization Program for older adults and adults with increased risk for pneumococcal disease, however, disease incidence and associated burden remain high. We evaluated the cost-effectiveness of pneumococcal conjugate vaccines (PCVs) for adults aged 65 years and high-risk adults aged 60-64 years in Japan.

Research design and methods: Using a Markov model, we evaluated lifetime costs using societal and healthcare payer perspectives and estimated quality-adjusted life-years (QALYs), and number of prevented cases and deaths caused by invasive pneumococcal disease (IPD) and non-IPD. The base case analysis used a societal perspective.

Results: In comparison with PPSV23, the 20-valent PCV (PCV20) prevented 127 IPD cases 10,813 non-IPD cases (inpatients: 2,461, outpatients: 8,352) and 226 deaths, and gained more QALYs (+0.0015 per person) with less cost (-JPY22,513 per person). All sensitivity and scenario analyses including a payer perspective analysis indicated that the incremental cost-effectiveness ratios (ICERs) were below the cost-effectiveness threshold value in Japan (JPY5 million/QALY).

Conclusions: PCV20 is both cost saving and more effective than PPSV23 for adults aged 65 years and high-risk adults aged 60-64 years in Japan.

背景:在日本国家免疫计划中,23 价肺炎球菌多糖疫苗 (PPSV23) 被用于老年人和肺炎球菌疾病风险较高的成年人,然而,疾病发病率和相关负担仍然很高。我们评估了日本 65 岁成人和 60-64 岁高风险成人接种肺炎球菌结合疫苗 (PCV) 的成本效益:我们使用马尔可夫模型,从社会和医疗支付方的角度评估了终生成本,并估算了质量调整生命年 (QALY),以及由侵袭性肺炎球菌疾病 (IPD) 和非 IPD 引起的预防病例数和死亡数。基础案例分析采用了社会视角:结果:与 PPSV23 相比,20 价 PCV(PCV20)可预防 127 例 IPD 病例、10,813 例非 IPD 病例(住院病人:2,461 例,门诊病人:8,352 例)和 226 例死亡,并以较低的成本(每人-22,513 日元)获得了更多的 QALY(每人+0.0015)。所有敏感性分析和情景分析(包括支付方视角分析)均表明,增量成本效益比(ICER)低于日本的成本效益阈值(500 万日元/QALY):结论:对于日本 65 岁的成年人和 60-64 岁的高风险成年人来说,PCV20 比 PPSV23 既节约成本又更有效。
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Expert Review of Vaccines
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