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Intentions to receive a potentially available Lyme disease vaccine in an urban sample. 在城市样本中接受可能可用的莱姆病疫苗的意图。
Pub Date : 2016-01-01 DOI: 10.1177/2051013616629881
Joshua Fogel, Martin Kusz

Objectives: The only human Lyme disease vaccine of LYMErix was voluntarily removed from the market in the United States in 2002 for a number of reasons. A new human Lyme disease vaccine is currently being developed. We would like any future approved human Lyme disease vaccine to be of interest and marketable to consumers.

Methods: We surveyed 714 participants to determine variables associated with intentions to receive a Lyme disease vaccine. Predictor variables included demographics, protection motivational theory, Lyme disease knowledge, Lyme disease preventive behaviors, beliefs and perceived health.

Results: We found in multivariate linear regression analyses that Asian/Asian American race/ethnicity (p < 0.001), South Asian race/ethnicity (p = 0.01) and coping appraisal variables of response efficacy (p < 0.001) and self-efficacy (p < 0.001) were each significantly associated with increased intentions. The belief that vaccines are typically not safe was significantly associated with decreased intentions (p = 0.03).

Conclusions: Asian/Asian American and South Asian race/ethnicities have a strong interest in receiving a Lyme disease vaccine. Although pharmaceutical companies may benefit by advertising a Lyme disease vaccine to Asian/Asian Americans and South Asians, marketers need to address and use approaches to interest those from other race/ethnicities. Also, marketers need to address the erroneous belief that vaccines are typically not safe in order to interest those with such beliefs to use a Lyme disease vaccine.

目的:唯一的人类莱姆病疫苗LYMErix在2002年出于多种原因自愿从美国市场上撤下。目前正在研制一种新的人类莱姆病疫苗。我们希望未来任何被批准的人类莱姆病疫苗都能引起消费者的兴趣,并能推向市场。方法:我们调查了714名参与者,以确定与接受莱姆病疫苗意向相关的变量。预测变量包括人口统计学、保护动机理论、莱姆病知识、莱姆病预防行为、信念和感知健康。结果:多元线性回归分析发现,亚洲/亚裔美国人种族/民族(p < 0.001)、南亚种族/民族(p = 0.01)以及反应效能(p < 0.001)和自我效能(p < 0.001)的应对评价变量均与意图增加显著相关。认为疫苗通常不安全的信念与意愿降低显著相关(p = 0.03)。结论:亚洲/亚裔美国人和南亚种族/族裔对接种莱姆病疫苗有浓厚兴趣。虽然制药公司可能会通过向亚洲/亚裔美国人和南亚人宣传莱姆病疫苗而受益,但营销人员需要解决并使用方法来吸引其他种族/民族的人。此外,营销人员需要解决疫苗通常不安全的错误观念,以吸引有这种观念的人使用莱姆病疫苗。
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引用次数: 5
Efficacy of varicella (VZV) vaccination: an update for the clinician. 水痘(VZV)疫苗接种的有效性:临床医生的更新。
Pub Date : 2016-01-01 DOI: 10.1177/2051013616655980
Lili Wang, Lucy Zhu, Hua Zhu

Varicella-zoster virus (VZV) infection causes two distinct clinical conditions. Primary varicella infection results in chickenpox, a contagious rash illness typically seen among children. VZV can reactivate years after the initial infection to cause herpes zoster (HZ) and lead to post-herpetic neuralgia, a common complication resulting in persistent pain that may last for years after the zoster rash resolves. A person's risk of having longer lasting and more severe pain associated with HZ increases with age. Since the introduction of VZV vaccines, the rates of infection, hospitalizations, and mortality have declined. In this review, we discuss in detail current VZV vaccines available for the prevention of VZV and HZ infections. Varilrix (GSK Biologicals, UK), Varivax (Merck, USA) and the combined measles, mumps, rubella, and varicella (MMRV) vaccine contain the live attenuated Oka strain of VZV for routine varicella vaccination. While Zostavax is the only HZ vaccine currently approved for use in the United States and the European Union [EMEA, 2011], a subunit vaccine candidate called HZ/su has recently shown improved efficacy for zoster prevention in two clinical trial phase III studies. VariZIG, a post-exposure prophylactic, uses zoster immune globulin to prevent VZV infection in those who have recently been in contact with VZV but lack evidence of varicella immunity and are contraindicated to receive the varicella vaccine. Further, we discuss the skin tropic and neurotropic factor VZV ORF7 gene and its involvement in varicella infection, reactivation and latency in ganglia. Ultimately, these studies can contribute to the development of a neuroattenuated vaccine candidate against varicella or a vector for delivery of other virus antigens.

水痘带状疱疹病毒(VZV)感染导致两种不同的临床症状。原发性水痘感染导致水痘,这是一种在儿童中常见的传染性皮疹疾病。VZV可在初次感染数年后重新激活,引起带状疱疹(HZ)并导致带状疱疹后神经痛,这是一种常见的并发症,导致带状疱疹皮疹消退后可能持续数年的持续疼痛。随着年龄的增长,一个人与HZ相关的持续时间更长、更严重的疼痛的风险也会增加。自从引进VZV疫苗以来,感染率、住院率和死亡率都有所下降。在这篇综述中,我们详细讨论了目前可用于预防VZV和HZ感染的VZV疫苗。Varilrix(英国GSK生物制品公司)、Varivax(美国默克公司)和麻疹、腮腺炎、风疹和水痘联合疫苗(MMRV)含有用于常规水痘疫苗接种的VZV减毒活疫苗Oka株。虽然Zostavax是目前在美国和欧盟批准使用的唯一一种带状疱疹疫苗[EMEA, 2011],但一种名为HZ/su的候选亚单位疫苗最近在两项临床试验III期研究中显示出更好的带状疱疹预防效果。VariZIG是一种暴露后预防疫苗,它使用带状疱疹免疫球蛋白来预防那些最近接触过VZV但缺乏水痘免疫证据且禁止接种水痘疫苗的人感染VZV。此外,我们还讨论了皮肤和神经营养因子VZV ORF7基因及其在水痘感染、再激活和神经节潜伏中的作用。最终,这些研究有助于开发针对水痘的神经减毒候选疫苗或用于递送其他病毒抗原的载体。
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引用次数: 42
Erratum. 勘误表。
Pub Date : 2016-01-01 DOI: 10.1177/2051013616634209

[This corrects the article DOI: 10.1177/2051013615599151.].

[这更正了文章DOI: 10.1177/2051013615599151.]。
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引用次数: 0
Cholera toxin B induced activation of murine macrophages exposed to a fixed bacterial immunogen 霍乱毒素B诱导暴露于固定细菌免疫原的小鼠巨噬细胞活化
Pub Date : 2015-09-01 DOI: 10.1177/2051013615613473
Kari Wiedinger, Heather Romlein, C. Bitsaktsis
Objectives: Previous studies have demonstrated that intranasal administration of inactivated (fixed) Francisella tularensis (iFt) live vaccine strain (LVS) in conjunction with the mucosal adjuvant, cholera toxin B (CTB), provides full protection against subsequent lethal challenge with Ft LVS and partial protection against the more virulent Ft SchuS4 strain. Understanding the mechanisms of CTB-induced immune stimulation that confer protection against Ft will be valuable to the development of an effective vaccine against this highly virulent fatal pathogen. In this study, an in vitro system was utilized to further elucidate the immunologic adjuvant effect of CTB when administered with the fixed bacterial immunogen iFt. Methods: The murine macrophage cell line (RAW264.7) was treated with combinations of iFt and CTB. The treated RAW264.7 cells and their supernatants were collected and assessed for cell surface marker expression and cytokine secretion. In addition, the ability of RAW264.7 cells to present bacterial antigens (iFt or LVS) to an Ft-specific T-cell hybridoma cell line, following exposure to CTB, was analyzed. Results: We found that RAW264.7 cells responded to treatment with iFt + CTB by an increased secretion of the proinflammatory cytokines interleukin 6 and tumor necrosis factor α and upregulation of the surface expression of toll-like receptor 4 and the costimulatory molecules CD80 and CD86. Furthermore, the experimental vaccine treatment iFt + CTB enhanced the ability of macrophages to present iFt antigens to an FT-specific T-cell hybridoma cell line, although they failed to do so with LVS. Conclusion: The adjuvant CTB administered in conjunction with iFt showed evidence of enhancing an antigen-specific proinflammatory response in vitro. These observations allow us to define, in part, the mechanisms of immune activation conferred by mucosal administration of iFt + CTB against lethal F. tularensis challenge.
目的:先前的研究表明,经鼻给药灭活(固定)土拉菌Francisella tularensis (iFt)活疫苗株(LVS)与粘膜佐剂霍乱毒素B (CTB)联合使用,可提供对Ft LVS后续致命攻击的完全保护,以及对毒性更强的Ft SchuS4菌株的部分保护。了解ctb诱导的免疫刺激机制对Ft具有保护作用,将对开发针对这种高毒力致命病原体的有效疫苗有价值。本研究利用体外系统进一步阐明固定细菌免疫原iFt对CTB的免疫佐剂作用。方法:采用iFt联合CTB治疗小鼠巨噬细胞(RAW264.7)。收集处理后的RAW264.7细胞及其上清液,检测细胞表面标志物的表达和细胞因子的分泌。此外,我们还分析了暴露于CTB后RAW264.7细胞向ft特异性t细胞杂交瘤细胞系呈递细菌抗原(iFt或LVS)的能力。结果:我们发现RAW264.7细胞对iFt + CTB的反应是促炎细胞因子白介素6和肿瘤坏死因子α的分泌增加,toll样受体4和共刺激分子CD80和CD86的表面表达上调。此外,实验性疫苗治疗iFt + CTB增强了巨噬细胞向ft特异性t细胞杂交瘤细胞系呈递iFt抗原的能力,尽管它们在LVS中没有这样做。结论:体外实验表明,CTB佐剂与iFt联合使用可增强抗原特异性促炎反应。这些观察结果使我们能够在一定程度上定义粘膜给药iFt + CTB对致死性土拉菌的免疫激活机制。
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引用次数: 4
Plant-based vaccines for animals and humans: recent advances in technology and clinical trials 动物和人用植物疫苗:技术和临床试验的最新进展
Pub Date : 2015-09-01 DOI: 10.1177/2051013615613272
N. Takeyama, H. Kiyono, Y. Yuki
It has been about 30 years since the first plant engineering technology was established. Although the concept of plant-based pharmaceuticals or vaccines motivates us to develop practicable commercial products using plant engineering, there are some difficulties in reaching the final goal: to manufacture an approved product. At present, the only plant-made vaccine approved by the United States Department of Agriculture is a Newcastle disease vaccine for poultry that is produced in suspension-cultured tobacco cells. The progress toward commercialization of plant-based vaccines takes much effort and time, but several candidate vaccines for use in humans and animals are in clinical trials. This review discusses plant engineering technologies and regulations relevant to the development of plant-based vaccines and provides an overview of human and animal vaccines currently under clinical trials.
从第一个工厂工程技术建立至今,已经有30多年的历史了。尽管基于植物的药物或疫苗的概念激励我们利用植物工程开发可行的商业产品,但在达到最终目标(生产批准的产品)方面存在一些困难。目前,美国农业部批准的唯一一种植物疫苗是一种用悬浮培养的烟草细胞生产的家禽新城疫疫苗。植物基疫苗的商业化进程需要花费大量精力和时间,但几种用于人类和动物的候选疫苗正在进行临床试验。本文讨论了与植物性疫苗开发相关的植物工程技术和法规,并概述了目前正在临床试验的人类和动物疫苗。
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引用次数: 122
Clinical development of Ebola vaccines. 埃博拉疫苗的临床开发。
Pub Date : 2015-09-01 DOI: 10.1177/2051013615611017
Saranya Sridhar

The ongoing outbreak of Ebola virus disease in West Africa highlighted the lack of a licensed drug or vaccine to combat the disease and has renewed the urgency to develop a pipeline of Ebola vaccines. A number of different vaccine platforms are being developed by assessing preclinical efficacy in animal models and expediting clinical development. Over 15 different vaccines are in preclinical development and 8 vaccines are now in different stages of clinical evaluation. These vaccines include DNA vaccines, virus-like particles and viral vectors such as live replicating vesicular stomatitis virus (rVSV), human and chimpanzee adenovirus, and vaccinia virus. Recently, in preliminary results reported from the first phase III trial of an Ebola vaccine, the rVSV-vectored vaccine showed promising efficacy. This review charts this rapidly advancing area of research focusing on vaccines in clinical development and discusses the future opportunities and challenges faced in the licensure and deployment of Ebola vaccines.

埃博拉病毒病在西非的持续爆发凸显了缺乏抗击该疾病的许可药物或疫苗的问题,这也再次激发了开发埃博拉疫苗管道的紧迫性。通过评估动物模型的临床前疗效和加快临床开发,目前正在开发一些不同的疫苗平台。目前有超过 15 种不同的疫苗处于临床前开发阶段,8 种疫苗已进入临床评估的不同阶段。这些疫苗包括 DNA 疫苗、病毒样颗粒和病毒载体,如活体复制水泡性口炎病毒 (rVSV)、人类和黑猩猩腺病毒以及疫苗病毒。最近,在埃博拉疫苗首次 III 期试验的初步结果中,rVSV 载体疫苗显示出良好的疗效。本综述以临床开发中的疫苗为重点,描绘了这一快速发展的研究领域,并讨论了埃博拉疫苗许可和部署方面未来面临的机遇和挑战。
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引用次数: 0
Herpes zoster epidemiology, management, and disease and economic burden in Europe: a multidisciplinary perspective. 欧洲带状疱疹流行病学、管理、疾病和经济负担:多学科视角。
Pub Date : 2015-07-01 DOI: 10.1177/2051013615599151
Robert W Johnson, Marie-José Alvarez-Pasquin, Marc Bijl, Elisabetta Franco, Jacques Gaillat, João G Clara, Marc Labetoulle, Jean-Pierre Michel, Luigi Naldi, Luis S Sanmarti, Thomas Weinke

Herpes zoster (HZ) is primarily a disease of nerve tissue but the acute and longer-term manifestations require multidisciplinary knowledge and involvement in their management. Complications may be dermatological (e.g. secondary bacterial infection), neurological (e.g. long-term pain, segmental paresis, stroke), ophthalmological (e.g. keratitis, iridocyclitis, secondary glaucoma) or visceral (e.g. pneumonia, hepatitis). The age-related increased incidence of HZ and its complications is thought to be a result of the decline in cell-mediated immunity (immunosenescence), higher incidence of comorbidities with age and social-environmental changes. Individuals who are immunocompromised as a result of disease or therapy are also at increased risk, independent of age. HZ and its complications (particularly postherpetic neuralgia) create a significant burden for the patient, carers, healthcare systems and employers. Prevention and treatment of HZ complications remain a therapeutic challenge despite recent advances. This is an overview of the multidisciplinary implications and management of HZ in which the potential contribution of vaccination to reducing the incidence HZ and its complications are also discussed.

带状疱疹(HZ)主要是一种神经组织疾病,但其急性和长期表现需要多学科知识和参与治疗。并发症可能是皮肤病(如继发细菌感染)、神经病(如长期疼痛、节段性瘫痪、中风)、眼病(如角膜炎、虹膜睫状体炎、继发性青光眼)或内脏病(如肺炎、肝炎)。与年龄相关的 HZ 及其并发症发病率增加被认为是细胞介导的免疫力下降(免疫衰老)、随着年龄增长合并症发病率增加以及社会环境变化的结果。因疾病或治疗而导致免疫力低下的人也会增加患病风险,这与年龄无关。HZ 及其并发症(尤其是带状疱疹后遗神经痛)给患者、护理者、医疗保健系统和雇主带来了沉重负担。尽管最近取得了一些进展,但 HZ 并发症的预防和治疗仍然是一项治疗挑战。本文概述了 HZ 的多学科影响和管理,其中还讨论了疫苗接种对降低 HZ 发病率及其并发症的潜在贡献。
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引用次数: 0
Safety, efficacy, and immunogenicity of Flublok in the prevention of seasonal influenza in adults. Flublok预防成人季节性流感的安全性、有效性和免疫原性。
Pub Date : 2015-07-01 DOI: 10.1177/2051013615595595
Manon M J Cox, Ruvim Izikson, Penny Post, Lisa Dunkle

Flublok is the first recombinant hemagglutinin (HA) vaccine licensed by the US Food and Drugs Administration for the prevention of influenza in adults aged 18 and older. The HA proteins produced in insect cell culture using the baculovirus expression system technology are exact analogues of wild type circulating influenza virus HAs. The universal HA manufacturing process that has been successfully scaled to the 21,000L contributes to rapid delivery of a substantial number of doses. This review discusses the immunogenicity, efficacy and safety data from five pivotal clinical studies used to support licensure of trivalent Flublok for adults 18 years of age and older in the United States. The trial data demonstrate that the higher antigen content in Flublok results in improved immunogenicity. Data further suggest improved efficacy and a slightly lower local reactogenicity compared with standard inactivated influenza vaccine, despite the presence of more antigen (statistically significant). Flublok influenza vaccine can include HAs designed to mimic 'drift' in influenza viruses as the process of predicting antigenic drift advances and, at a minimum, could address late appearing influenza viruses. The implementation of the latter will require support from regulatory authorities.

Flublok是美国食品和药物管理局批准的首个重组血凝素(HA)疫苗,用于预防18岁及以上成年人的流感。利用杆状病毒表达系统技术在昆虫细胞培养中产生的HA蛋白是野生型循环流感病毒HA的精确类似物。通用的HA制造工艺已经成功地扩展到21,000L,有助于快速交付大量剂量。本综述讨论了五项关键性临床研究的免疫原性、有效性和安全性数据,这些研究用于支持三价Flublok在美国18岁及以上成人的许可。试验数据表明,Flublok中较高的抗原含量可提高免疫原性。数据进一步表明,与标准灭活流感疫苗相比,尽管存在更多的抗原,但疗效提高,局部反应原性略低(具有统计学意义)。随着预测抗原漂移过程的进展,Flublok流感疫苗可以包括旨在模拟流感病毒“漂移”的HAs,并且至少可以解决出现较晚的流感病毒。后者的实施将需要监管当局的支持。
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引用次数: 83
Group B Streptococcus vaccine: state of the art. B群链球菌疫苗:最先进的。
Pub Date : 2015-05-01 DOI: 10.1177/2051013615579869
Annalisa Nuccitelli, C Daniela Rinaudo, Domenico Maione

Group B Streptococcus (GBS) is cause of neonatal invasive diseases as well as of severe infections in the elderly and immune-compromised patients. Despite significant advances in the prevention and treatment of neonatal disease, sepsis and meningitis caused by GBS still represent a significant public health care concern globally and additional prevention and therapeutic strategies against infection are highly desirable. The introduction of national recommended guidelines in several countries to screen pregnant women for GBS carriage and the use of antibiotics during delivery significantly reduced disease occurring within the first hours of life (early-onset disease), but it has had no effect on the late-onset diseases occurring after the first week and is not feasible in most countries. Availability of an effective vaccine against GBS would provide an effective means of controlling GBS disease. This review provides an overview of the burden of invasive disease caused by GBS in infants and adults, and highlights the strategies for the development of an effective vaccine against GBS infections.

B群链球菌(GBS)是新生儿侵袭性疾病以及老年人和免疫功能低下患者严重感染的原因。尽管在预防和治疗新生儿疾病方面取得了重大进展,但由GBS引起的败血症和脑膜炎仍然是全球公共卫生保健的一个重大问题,因此非常需要额外的预防和治疗感染战略。一些国家采用国家推荐指南筛查孕妇是否携带吉兰-巴雷综合征,并在分娩期间使用抗生素,这大大减少了生命最初几个小时内发生的疾病(早发性疾病),但对第一周后发生的迟发性疾病没有影响,在大多数国家是不可行的。获得有效的GBS疫苗将提供控制GBS疾病的有效手段。本文综述了由GBS引起的婴儿和成人侵袭性疾病的负担,并强调了开发针对GBS感染的有效疫苗的策略。
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引用次数: 97
Recent advances in immunotherapy and vaccine development for peanut allergy. 花生过敏免疫治疗及疫苗研究进展。
Pub Date : 2015-05-01 DOI: 10.1177/2051013615591739
Katherine Anagnostou

Peanut allergy is a common problem and can be the cause of severe, life-threatening allergic reactions. It rarely resolves, with the majority of patients carrying the disease onto adulthood. Peanut allergy poses a significant burden on the quality of life of sufferers and their families, which results mainly from the fear of accidental peanut ingestion, but is also due to dietary and social restrictions. Current standard management involves avoidance, patient education and provision of emergency medication, for use in allergic reactions, when they occur. Efforts have been made to develop a vaccine for peanut allergy. Recent developments have also highlighted the use of immunotherapy, which has shown promise as an active form of treatment and may present a disease-modifying therapy for peanut allergy. So far, results, especially from oral immunotherapy studies, have shown good efficacy in achieving desensitization to peanut with a good safety profile. However, the capacity to induce long-term tolerance has not been demonstrated conclusively yet and larger, phase III studies are required to further investigate safety and efficacy of this intervention. Peanut immunotherapy is not currently recommended for routine clinical use or outside specialist allergy units.

花生过敏是一种常见的问题,可能会导致严重的、危及生命的过敏反应。这种病很少能痊愈,大多数患者成年后仍会患病。花生过敏对患者及其家人的生活质量造成重大负担,这主要是由于担心意外摄入花生,但也有饮食和社会限制的原因。目前的标准管理包括避免、患者教育和提供紧急药物,以便在发生过敏反应时使用。人们一直在努力研制花生过敏疫苗。最近的发展也强调了免疫疗法的使用,它已显示出作为一种积极治疗形式的希望,并可能为花生过敏提供一种改善疾病的疗法。到目前为止,结果,特别是口服免疫疗法的研究,已经显示出对花生脱敏的良好效果,并且具有良好的安全性。然而,诱导长期耐受性的能力尚未得到最终证明,需要更大规模的III期研究来进一步研究这种干预措施的安全性和有效性。花生免疫疗法目前不推荐常规临床使用或专科过敏单位以外。
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引用次数: 12
期刊
Therapeutic advances in vaccines
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