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COVID-19 InfoVaccines: A WHO-supported educational project to promote COVID-19 vaccination information among professionals and the general population. COVID-19 信息疫苗:世界卫生组织支持的一个教育项目,旨在向专业人员和普通民众宣传 COVID-19 疫苗接种信息。
IF 4.8 4区 医学 Q2 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2024-12-31 Epub Date: 2024-05-23 DOI: 10.1080/21645515.2024.2350817
Narmeen Mallah, Jacobo Pardo-Seco, Irene Rivero-Calle, Ouhao Zhu-Huang, María Fernández Prada, Catharina Reynen-de Kat, Oleg Benes, Liudmila Mosina, Siddhartha Sankar-Datta, Olga Aleksinskaya, David Díaz, Vusala Allahverdiyeva, Yevgenii Grechukha, Tamara Jobava, Mariia Savchyna, Pavla Kortusova, Ioana Novac, Federico Martinón-Torres

COVID-19 vaccine uptake varied across countries, in part due to vaccine hesitancy fueled by a lack of trustworthy information. To help health workers provide evidence-based answers to common questions about COVID-19 vaccines and vaccination, and thereby, assist individuals´ decisions on vaccine acceptance, COVID-19 InfoVaccines, a joint WHO-EU project, was launched in February 2021 to support COVID-19 vaccine rollout in 6 Eastern European countries. COVID-19 InfoVaccines was made available in seven languages and shared on social media networks. A total of 262,592 users accessed COVID-19 InfoVaccines.com between February 11, 2021, and January 31st, 2023. The users were most interested in: general questions; vaccine efficacy and duration of protection; vaccine safety; vaccine co-administration, and dose-interval and interchangeability; though the interest in a specific theme varied in function of the epidemiological situation. A total of 118,510 (45.1%) and 46,644 (17.7%) users scrolled up to 35% and 75% of the COVID-19 InfoVaccines webpage, respectively. The average engagement rate was 71.61%. The users accessed COVID-19 InfoVaccines from 231 countries and territories, but the majority were in Ukraine (N = 38,404; 14.6%), Spain (N = 23,327; 8.9%), and Argentina (N = 21,167; 8.1%). Older Facebook users were more interested in COVID-19 information than younger individuals (X2 p-value < .0001). Two hundred twenty-eight videos were shared on YouTube. The average Click-Through-Rate on Facebook was 7.82%, and that on YouTube was 4.4%, with 60 videos having a Click-Through-Rate >5%, falling in the range of average YouTube video Click-Through-Rate (2% - 10%). As misinformation about vaccines and vaccination spreads easily and can negatively impact health-related decisions, initiatives like COVID-19 InfoVaccines are crucial to facilitate access to reliable information.

各国对 COVID-19 疫苗的接种率不尽相同,部分原因是缺乏可信的信息导致人们对疫苗犹豫不决。为了帮助卫生工作者对有关 COVID-19 疫苗和疫苗接种的常见问题提供循证解答,从而帮助个人做出接受疫苗的决定,世卫组织和欧盟于 2021 年 2 月联合启动了 COVID-19 InfoVaccines 项目,以支持 COVID-19 疫苗在 6 个东欧国家的推广。COVID-19 InfoVaccines 以七种语言提供,并在社交媒体网络上共享。从 2021 年 2 月 11 日到 2023 年 1 月 31 日,共有 262,592 名用户访问了 COVID-19 InfoVaccines.com。用户最感兴趣的问题包括:一般问题;疫苗的有效性和保护期;疫苗的安全性;疫苗的联合使用以及剂量间隔和互换性;尽管对特定主题的兴趣因流行病学状况而异。共有 118,510 名用户(45.1%)和 46,644 名用户(17.7%)分别滚动浏览了 COVID-19 疫苗信息网页的 35% 和 75%。平均参与率为 71.61%。访问 COVID-19 疫苗信息的用户来自 231 个国家和地区,但大多数来自乌克兰(38,404 人;14.6%)、西班牙(23,327 人;8.9%)和阿根廷(21,167 人;8.1%)。年龄较大的 Facebook 用户比年轻人对 COVID-19 信息更感兴趣(X2 p 值 < .0001)。YouTube 上共分享了 228 个视频。Facebook 上的平均点击率为 7.82%,YouTube 上的平均点击率为 4.4%,其中 60 个视频的点击率大于 5%,处于 YouTube 视频平均点击率(2% - 10%)的范围内。由于有关疫苗和疫苗接种的错误信息很容易传播,并可能对健康相关决策产生负面影响,因此 COVID-19 InfoVaccines 等倡议对于促进获取可靠信息至关重要。
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引用次数: 0
Trends in the administration of COVID-19 vaccines with other vaccines in the United States reported to V-safe during December 14, 2020-May 19, 2023. 2020 年 12 月 14 日至 2023 年 5 月 19 日期间美国向 V-safe 报告的 COVID-19 疫苗与其他疫苗混合使用的趋势。
IF 4.8 4区 医学 Q2 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2024-12-31 Epub Date: 2024-06-07 DOI: 10.1080/21645515.2024.2361946
Casey E Parker, Anne M Hause, Paige Marquez, Bicheng Zhang, Tanya R Myers, David K Shay

Introduction COVID-19 vaccines may be administered with other vaccines during the same healthcare visit. COVID-19 monovalent (Fall 2021) and bivalent (Fall 2022) vaccine recommendations coincided with annual seasonal influenza vaccination. Data describing the frequency of the co-administration of COVID-19 vaccines with other vaccines are limited. Methods We used V-safe, a voluntary smartphone-based U.S. safety surveillance system established by the CDC, to describe trends in the administration of COVID-19 vaccines with other vaccines reported to V-safe during December 14, 2020 - May 19, 2023. Results Of the 21 million COVID-19 vaccinations reported to V-safe, 2.2% (459,817) were administered with at least 1 other vaccine. Co-administration most frequently occurred during the first week of October 2023 (27,092; 44.1%). Most reports of co-administration included influenza vaccine (393,003; 85.5%). Co-administration was most frequently reported for registrants aged 6 months-6 years (4,872; 4.4%). Conclusion Reports of co-administration to V-safe peaked during October 2023, when influenza vaccination most often occurs, possibly reflecting increased opportunities for multiple vaccinations and greater acceptability of the co-administration of COVID-19 vaccine with other vaccines, especially influenza vaccine.

导言 COVID-19 疫苗可与其他疫苗在同一医疗保健就诊期间同时接种。COVID-19单价疫苗(2021年秋季)和二价疫苗(2022年秋季)的推荐接种时间与每年的季节性流感疫苗接种时间一致。描述 COVID-19 疫苗与其他疫苗联合接种频率的数据非常有限。方法 我们利用美国疾病预防控制中心建立的自愿性智能手机安全监控系统 V-safe,描述了 2020 年 12 月 14 日至 2023 年 5 月 19 日期间向 V-safe 报告的 COVID-19 疫苗与其他疫苗联合接种的趋势。结果 在向 V-safe 报告的 2100 万例 COVID-19 疫苗接种中,2.2%(459,817 例)与至少一种其他疫苗同时接种。联合接种最常发生在 2023 年 10 月的第一周(27,092;44.1%)。大多数联合接种报告都包括流感疫苗(393,003;85.5%)。6个月至6岁的注册者最常报告联合用药(4,872;4.4%)。结论 向 V-safe 报告联合接种的情况在 2023 年 10 月达到高峰,而这一时期是流感疫苗接种最频繁的时期,这可能反映了多种疫苗接种机会的增加,以及人们对 COVID-19 疫苗与其他疫苗(尤其是流感疫苗)联合接种的接受度更高。
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引用次数: 0
Knowledge, awareness, and correlates of HPV vaccine acceptability among male junior high school students in Zhejiang Province, China. 中国浙江省男性初中生对 HPV 疫苗的知识、认知及相关接受度。
IF 4.8 4区 医学 Q2 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2024-12-31 Epub Date: 2024-06-13 DOI: 10.1080/21645515.2024.2357238
Xiang Zhao, Yu Huang, Qiaohong Lv, Lei Wang, Suxian Wu, Qingqing Wu

This study assessed the knowledge of 12- to 15-year-old male junior high school students of HPV and HPV vaccines and their willingness to be vaccinated against it. From March to May 2023, students from six junior high schools in Zhejiang Province were randomly selected to complete an online, anonymous, self-administered questionnaire. Of the 1786 students, 618 (34.6%) reported knowledge of HPV vaccine. In general, junior high school boys have low general knowledge about HPV, the consequences of HPV infection, and the effects of HPV vaccination. Multivariate analysis showed that the subgroup scoring 6-7 on the measure of the consequences of HPV infection(7 questions with 1 score for each correct answer) compared to the subgroup scoring 0, the subgroups scoring 2 and 3 on the measure of the preventive effect of HPV vaccine(3 questions with 1 score for each correct answer) compared to the subgroup scoring 0 were were more likely to be willing to be vaccinated against HPV. Hearing that someone close to them had cancer, believing that men also need to be vaccinated against HPV, knowing that someone close to them had been vaccinated against HPV, and being concerned about cervical cancer in their female sexual partners were all more likely to generate positive responses. HPV vaccine education for this group of students should emphasize the possibility and consequences of HPV infection in males, along with the importance and benefits of HPV vaccination; actual cases of vaccination in students around them can be used to achieve this goal.

本研究评估了 12-15 岁男性初中生对人类乳头瘤病毒和人类乳头瘤病毒疫苗的了解程度及其接种意愿。2023 年 3 月至 5 月,研究人员随机抽取了浙江省 6 所初中的学生,让他们填写了一份匿名的在线自填问卷。在1786名学生中,有618人(34.6%)表示了解HPV疫苗。总体而言,初中男生对HPV、HPV感染的后果以及接种HPV疫苗的效果等常识知晓率较低。多变量分析表明,与得分为 0 的亚组相比,在 "HPV 感染的后果"(7 个问题,每个正确答案得 1 分)方面得分为 6-7 的亚组,在 "HPV 疫苗的预防效果"(3 个问题,每个正确答案得 1 分)方面得分为 2 和 3 的亚组,与得分为 0 的亚组相比,更愿意接种 HPV 疫苗。听说身边有人罹患癌症、认为男性也需要接种 HPV 疫苗、知道身边有人接种过 HPV 疫苗以及担心女性性伴侣患宫颈癌,都更有可能产生积极的反应。针对这部分学生的 HPV 疫苗教育应强调男性感染 HPV 的可能性和后果,以及接种 HPV 疫苗的重要性和益处;可以利用身边学生接种疫苗的实际案例来实现这一目标。
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引用次数: 0
Inactivated influenza virus vaccines expressing COBRA hemagglutinin elicited broadly reactive, long-lived protective antibodies. 表达 COBRA 血凝素的灭活流感病毒疫苗可激发广泛反应性的长效保护性抗体。
IF 4.8 4区 医学 Q2 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2024-12-31 Epub Date: 2024-06-02 DOI: 10.1080/21645515.2024.2356269
Hua Shi, Xiaojian Zhang, Pan Ge, Victoria Meliopoulos, Pam Freiden, Brandi Livingston, Stacey Schultz-Cherry, Ted M Ross

The influenza viruses cause seasonal respiratory illness that affect millions of people globally every year. Prophylactic vaccines are the recommended method to prevent the breakout of influenza epidemics. One of the current commercial influenza vaccines consists of inactivated viruses that are selected months prior to the start of a new influenza season. In many seasons, the vaccine effectiveness (VE) of these vaccines can be relatively low. Therefore, there is an urgent need to develop an improved, more universal influenza vaccine (UIV) that can provide broad protection against various drifted strains in all age groups. To meet this need, the computationally optimized broadly reactive antigen (COBRA) methodology was developed to design a hemagglutinin (HA) molecule as a new influenza vaccine. In this study, COBRA HA-based inactivated influenza viruses (IIV) expressing the COBRA HA from H1 or H3 influenza viruses were developed and characterized for the elicitation of immediate and long-term protective immunity in both immunologically naïve or influenza pre-immune animal models. These results were compared to animals vaccinated with IIV vaccines expressing wild-type H1 or H3 HA proteins (WT-IIV). The COBRA-IIV elicited long-lasting broadly reactive antibodies that had hemagglutination-inhibition (HAI) activity against drifted influenza variants.

流感病毒导致季节性呼吸道疾病,每年影响全球数百万人。预防性疫苗是防止流感流行的推荐方法。目前的一种商用流感疫苗由灭活病毒组成,在新流感季节开始前几个月进行挑选。在许多季节中,这些疫苗的有效性(VE)可能相对较低。因此,迫切需要开发一种改进的、更通用的流感疫苗 (UIV),为所有年龄组的人提供广泛的保护,以抵御各种漂移毒株。为了满足这一需求,我们开发了计算优化广泛反应抗原(COBRA)方法来设计一种血凝素(HA)分子作为新型流感疫苗。本研究开发了基于 COBRA HA 的灭活流感病毒 (IIV),该病毒表达了来自 H1 或 H3 流感病毒的 COBRA HA,并在免疫幼稚动物模型或流感免疫前动物模型中激发了即刻和长期的保护性免疫。这些结果与接种了表达野生型 H1 或 H3 HA 蛋白(WT-IIV)的 IIV 疫苗的动物进行了比较。COBRA-IIV 能激发持久的广泛反应性抗体,对流感病毒的变种具有血凝抑制(HAI)活性。
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引用次数: 0
A systematic literature review of the epidemiology and burden of herpes zoster in selected locales in Asia Pacific. 关于亚太地区部分地区带状疱疹流行病学和负担的系统文献综述。
IF 4.8 4区 医学 Q2 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2024-12-31 Epub Date: 2024-05-20 DOI: 10.1080/21645515.2024.2344983
Jing Chen, Page E Abrahamson, Yu Ke, Chin Rong Ong, Raunak Parikh, Sumitra Shantakumar

Herpes zoster (HZ) is a painful rash which typically affects older adults. This is of concern in Asia-Pacific given its aging population. As HZ epidemiology and burden are evolving, this systematic literature review aimed to update the current understanding of HZ burden and associated costs for selected Asia-Pacific locales. MEDLINE and Embase were searched for English articles of HZ studies conducted in Australia, China, Hong Kong, Japan, Korea, New Zealand, Singapore, and Taiwan. Eligible outcomes included HZ incidence and prevalence, occurrence of HZ-related complications, healthcare resource utilization, costs, and HZ-associated quality of life outcomes. This paper focused on HZ data in the general adult population (N = 90 articles). Substantial HZ-related disease and economic burden were observed in these locales, consistent with global trends. These findings reinforce the increasing burden of HZ and need for preventive strategies, which may include raising awareness and encouraging timely vaccination.

带状疱疹(HZ)是一种常见于老年人的疼痛性皮疹。鉴于亚太地区人口老龄化严重,这一问题备受关注。随着 HZ 流行病学和负担的不断发展,本系统性文献综述旨在更新目前对选定亚太地区 HZ 负担和相关成本的了解。我们在 MEDLINE 和 Embase 中检索了在澳大利亚、中国、香港、日本、韩国、新西兰、新加坡和台湾进行的 HZ 研究的英文文章。符合条件的结果包括 HZ 发病率和流行率、HZ 相关并发症的发生率、医疗资源利用率、成本以及与 HZ 相关的生活质量结果。本文重点关注普通成年人群中的 HZ 数据(N = 90 篇文章)。在这些地区观察到了大量与 HZ 相关的疾病和经济负担,这与全球趋势一致。这些研究结果进一步说明了 HZ 带来的日益沉重的负担以及对预防策略的需求,其中可能包括提高认识和鼓励及时接种疫苗。
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引用次数: 0
Immunogenicity and safety of Ad26.RSV.preF/RSV preF protein vaccine at predicted intermediate- and end-of-shelf-life as an evaluation of potency throughout shelf life. Ad26.RSV.preF/RSV preF 蛋白疫苗在预测的保质期中期和末期的免疫原性和安全性,作为对整个保质期有效性的评估。
IF 4.8 4区 医学 Q2 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2024-12-31 Epub Date: 2024-05-23 DOI: 10.1080/21645515.2024.2344970
Tessa Hosman, Roy van Heesbeen, Arangassery Rosemary Bastian, Weihong Hu, Christy Comeaux, Nynke Ligtenberg, Bart van Montfort, Benoît Callendret, Esther Heijnen

This study assessed three Ad26.RSV.preF/RSV preF protein combinations, combining different Ad26.RSV.preF doses and naturally aged preF protein, representing the expected critical vaccine quality attributes close to release, around intermediate shelf-life (ISL) and near-presumed end-of-shelf-life (EoSL), as a way to evaluate the vaccine immunogenicity and safety throughout its shelf-life. A single dose of Ad26.RSV.preF/RSV preF protein vaccine was administered to adults 60-75 years of age. Solicited adverse events (AEs), unsolicited AEs, and serious AEs (SAEs) were assessed for 7-day, 28-day, and 6-month periods after vaccination, respectively. RSV preF-binding antibody concentrations and RSV neutralizing titers were measured 14 days post-vaccination as primary and secondary endpoints, respectively; binding antibodies were also measured 6 months post-vaccination. The RSV preF-binding antibody responses induced by Ad26.RSV.preF/RSV preF protein vaccine lots representing the critical quality attributes around ISL and near presumed EoSL were noninferior to the responses induced by the vaccine lot representing the critical quality attributes near release. The RSV preF-binding and RSV neutralizing antibody levels measured 14 days post-vaccination were similar across the 3 groups. RSV preF-binding antibody concentrations were also similar 6 months post-vaccination. Solicited AEs were mostly mild to moderate in intensity, and a decreased reactogenicity was observed from the Release group to the ISL and EoSL group. None of the reported SAEs were considered related to study vaccination. The study provided evidence of sustained immunogenicity and safety over the intended shelf-life of the Ad26.RSV.pref/RSV preF protein vaccine. The three vaccine lots had acceptable safety profiles.

本研究评估了三种 Ad26.RSV.preF/RSV preF 蛋白组合,它们结合了不同剂量的 Ad26.RSV.preF 和自然老化的 preF 蛋白,分别代表了临近上市、中间保质期 (ISL) 左右和接近假定保质期 (EoSL) 的预期关键疫苗质量属性,以此评估疫苗在整个保质期内的免疫原性和安全性。为 60-75 岁的成年人接种了单剂量的 Ad26.RSV.preF/RSV preF 蛋白疫苗。分别对接种后 7 天、28 天和 6 个月的主动不良事件 (AE)、非主动不良事件和严重不良事件 (SAE) 进行了评估。接种后 14 天分别测量 RSV 前 F 结合抗体浓度和 RSV 中和滴度,作为主要和次要终点;接种后 6 个月也测量结合抗体。Ad26.RSV.preF/RSV preF蛋白疫苗批次诱导的RSV前F结合抗体反应代表了ISL附近和假定EoSL附近的关键质量属性,与代表临近释放的关键质量属性的疫苗批次诱导的反应相比并不逊色。接种后 14 天测定的 RSV 结合前抗体和 RSV 中和抗体水平在 3 组中相似。接种后 6 个月的 RSV 前 F 结合抗体浓度也相似。诱发性 AEs 大部分为轻度至中度,从释放组到 ISL 和 EoSL 组均观察到反应性降低。所报告的不良反应均与疫苗接种无关。该研究提供了 Ad26.RSV.pref/RSV preF 蛋白疫苗在预定保质期内具有持续免疫原性和安全性的证据。三个批次疫苗的安全性均可接受。
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引用次数: 0
Exploring parental perspectives: Maternal RSV vaccination versus infant RSV monoclonal antibody. 探索父母的观点:母亲 RSV 疫苗接种与婴儿 RSV 单克隆抗体对比。
IF 4.8 4区 医学 Q2 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2024-12-31 Epub Date: 2024-05-09 DOI: 10.1080/21645515.2024.2341505
Bryony Treston, Sarah Geoghegan

Respiratory Syncytial Virus poses a significant global public health threat, particularly affecting infants aged less than one year of age. Recently, two forms of passive immunization against infant RSV have been developed and brought to market; nirsevimab a long-acting monoclonal antibody (mAb) and RSV-PreF, a maternal RSV vaccine. The acceptability and uptake of these products will play a pivotal role in determining the success of any national immunization strategy aimed at safeguarding infants from RSV. It is crucial at this time to reflect on the factors that influence parental decisions surrounding immunization to facilitate more informed discussions, enhance healthcare communication, and contribute to the design of effective RSV prevention strategies that resonate with the concerns and aspirations of parents worldwide.

呼吸道合胞病毒对全球公共卫生构成重大威胁,尤其影响一岁以内的婴儿。最近,有两种针对婴儿 RSV 的被动免疫方式被开发出来并推向市场:长效单克隆抗体 (mAb) nirsevimab 和母体 RSV 疫苗 RSV-PreF。这些产品的可接受性和使用率将在决定任何旨在保护婴儿免受 RSV 感染的国家免疫战略的成败方面发挥关键作用。此时此刻,对影响家长围绕免疫接种做出决定的因素进行反思至关重要,以促进更知情的讨论,加强医疗保健沟通,并为制定有效的 RSV 预防策略做出贡献,从而与全球家长的关切和期望产生共鸣。
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引用次数: 0
Neutralizing activity of anti-respiratory syncytial virus monoclonal antibody produced in Nicotiana benthamiana. 用烟花椰菜生产的抗呼吸道合胞病毒单克隆抗体的中和活性。
IF 4.8 4区 医学 Q2 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2024-12-31 Epub Date: 2024-03-20 DOI: 10.1080/21645515.2024.2327142
Nuttapat Pisuttinusart, Kaewta Rattanapisit, Chanya Srisaowakarn, Arunee Thitithanyanont, Richard Strasser, Balamurugan Shanmugaraj, Waranyoo Phoolcharoen

Respiratory syncytial virus (RSV) is a highly contagious virus that affects the lungs and respiratory passages of many vulnerable people. It is a leading cause of lower respiratory tract infections and clinical complications, particularly among infants and elderly. It can develop into serious complications such as pneumonia and bronchiolitis. The development of RSV vaccine or immunoprophylaxis remains highly active and a global health priority. Currently, GSK's Arexvy™ vaccine is approved for the prevention of lower respiratory tract disease in older adults (>60 years). Palivizumab and currently nirsevimab are the approved monoclonal antibodies (mAbs) for RSV prevention in high-risk patients. Many studies are ongoing to develop additional therapeutic antibodies for preventing RSV infections among newborns and other susceptible groups. Recently, additional antibodies have been discovered and shown greater potential for development as therapeutic alternatives to palivizumab and nirsevimab. Plant expression platforms have proven successful in producing recombinant proteins, including antibodies, offering a potential cost-effective alternative to mammalian expression platforms. Hence in this study, an attempt was made to use a plant expression platform to produce two anti-RSV fusion (F) mAbs 5C4 and CR9501. The heavy-chain and light-chain sequences of both these antibodies were transiently expressed in Nicotiana benthamiana plants using a geminiviral vector and then purified using single-step protein A affinity column chromatography. Both these plant-produced mAbs showed specific binding to the RSV fusion protein and demonstrate effective viral neutralization activity in vitro. These preliminary findings suggest that plant-produced anti-RSV mAbs are able to neutralize RSV in vitro.

呼吸道合胞病毒(RSV)是一种传染性极强的病毒,会影响许多易感人群的肺部和呼吸道。它是导致下呼吸道感染和临床并发症的主要原因,尤其是在婴儿和老年人中。它可发展成肺炎和支气管炎等严重并发症。目前,RSV 疫苗或免疫预防剂的研发仍处于高度活跃期,是全球健康领域的优先事项。目前,葛兰素史克的 Arexvy™ 疫苗已被批准用于预防老年人(大于 60 岁)的下呼吸道疾病。Palivizumab 和目前的 nirsevimab 是获批用于高危患者 RSV 预防的单克隆抗体 (mAbs)。目前正在进行多项研究,以开发出更多用于预防新生儿和其他易感人群 RSV 感染的治疗性抗体。最近,又发现了一些抗体,并显示出作为帕利珠单抗和 nirsevimab 治疗替代品的更大开发潜力。植物表达平台已被证明能成功生产包括抗体在内的重组蛋白,为哺乳动物表达平台提供了一种潜在的具有成本效益的替代方案。因此,本研究尝试利用植物表达平台生产两种抗 RSV 融合(F)mAbs 5C4 和 CR9501。这两种抗体的重链和轻链序列都是用geminiviral载体在烟草植物中瞬时表达的,然后用单步蛋白A亲和柱色谱法纯化。这两种植物生产的 mAbs 都显示出与 RSV 融合蛋白的特异性结合,并在体外显示出有效的病毒中和活性。这些初步研究结果表明,植物生产的抗 RSV mAbs 能够在体外中和 RSV。
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引用次数: 0
Intranasal delivery of Salmonella OMVs decorated with Chlamydia trachomatis antigens induces specific local and systemic immune responses. 用沙眼衣原体抗原装饰的沙门氏菌 OMV 经鼻内给药可诱导特异性局部和全身免疫反应。
IF 4.8 4区 医学 Q2 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2024-12-31 Epub Date: 2024-03-22 DOI: 10.1080/21645515.2024.2330768
Dung T Huynh, Emanuele Nolfi, Lobna Medfai, Peter van Ulsen, Wouter S P Jong, Alice J A M Sijts, Joen Luirink

Chlamydia trachomatis is an obligate intracellular pathogen responsible for the most prevalent bacterial sexually transmitted disease globally. The high prevalence of chlamydial infections underscores the urgent need for licensed and effective vaccines to prevent transmission in populations. Bacterial outer membrane vesicles (OMVs) have emerged as promising mucosal vaccine carriers due to their inherent adjuvant properties and the ability to display heterologous antigens. In this proof-of-concept study, we evaluated the immunogenicity of Salmonella OMVs decorated with C. trachomatis MOMP-derived CTH522 or HtrA antigens in mice. Following a prime-boost intranasal vaccination approach, two OMV-based C. trachomatis vaccines elicited significant humoral responses specific to the antigens in both systemic and vaginal compartments. Furthermore, we demonstrated strong antigen-specific IFN-γ and IL17a responses in splenocytes and cervical lymph node cells of vaccinated mice, indicating CD4+ Th1 and Th17 biased immune responses. Notably, the OMV-CTH522 vaccine also induced the production of spleen-derived CD8+ T cells expressing IFN-γ. In conclusion, these results highlight the potential of OMV-based C. trachomatis vaccines for successful use in future challenge studies and demonstrate the suitability of our modular OMV platform for intranasal vaccine applications.

沙眼衣原体是一种强制性细胞内病原体,是全球最常见的细菌性性传播疾病。衣原体感染的高发病率凸显了对许可和有效疫苗的迫切需求,以防止在人群中传播。细菌外膜囊泡 (OMV) 因其固有的佐剂特性和显示异源抗原的能力,已成为前景广阔的粘膜疫苗载体。在这项概念验证研究中,我们评估了用沙眼衣原体 MOMP 衍生的 CTH522 或 HtrA 抗原装饰的沙门氏菌 OMV 在小鼠体内的免疫原性。在采用原代强化鼻内接种方法后,两种基于 OMV 的沙眼衣原体疫苗在全身和阴道内都引起了明显的抗原特异性体液反应。此外,我们还在接种疫苗的小鼠脾细胞和宫颈淋巴结细胞中证实了强烈的抗原特异性 IFN-γ 和 IL17a 反应,这表明 CD4+ Th1 和 Th17 偏向免疫反应。值得注意的是,OMV-CTH522 疫苗还能诱导产生表达 IFN-γ 的脾源性 CD8+ T 细胞。总之,这些结果凸显了基于 OMV 的沙眼衣原体疫苗在未来挑战研究中成功应用的潜力,并证明了我们的模块化 OMV 平台在鼻内疫苗应用中的适用性。
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引用次数: 0
Seropersistence of SII-ChAdOx1 nCoV-19 (COVID-19 vaccine): 6-month follow-up of a randomized, controlled, observer-blind, phase 2/3 immuno-bridging study in Indian adults. SII-ChAdOx1 nCoV-19(COVID-19 疫苗)的血清持续性:在印度成年人中开展的为期 6 个月的随机对照观察盲法 2/3 期免疫桥接研究。
IF 4.8 4区 医学 Q2 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2024-12-31 Epub Date: 2024-03-21 DOI: 10.1080/21645515.2024.2304974
Prasad S Kulkarni, Chandrasekaran Padmapriyadarsini, Johan Vekemans, Ashish Bavdekar, Madhu Gupta, Praveen Kulkarni, B S Garg, Nithya J Gogtay, Muralidhar Tambe, Sanjay Lalwani, Kiranjit Singh, Renuka Munshi, Sushant Meshram, T S Selvavinayagam, Krishna Pandey, Devi Madhavi Bhimarasetty, S R Ramakrishnan, Chetanraj Bhamare, Abhijeet Dharmadhikari, Chandrashekhar Budhawant, Cyrille J Bonhomme, Madhuri Thakar, Swarali N Kurle, Elizabeth J Kelly, Manish Gautam, Nivedita Gupta, Samiran Panda, Balram Bhargava, Cyrus S Poonawalla, Umesh Shaligram, Dhananjay Kapse, Bhagwat Gunale

AZD1222 (ChAdOx1 nCoV-19) is a replication-deficient adenoviral vectored coronavirus disease-19 (COVID-19) vaccine that is manufactured as SII-ChAdOx1 nCoV-19 by the Serum Institute of India Pvt Ltd following technology transfer from Oxford University/AstraZeneca. The non-inferiority of SII-ChAdOx1 nCoV-19 with AZD1222 was previously demonstrated in an observer-blind, phase 2/3 immuno-bridging study (trial registration: CTRI/2020/08/027170). In this analysis of immunogenicity and safety data 6 months post first vaccination (Day 180), 1,601 participants were randomized 3:1 to SII-ChAdOx1 nCoV-19 or AZD1222 (immunogenicity/reactogenicity cohort n = 401) and 3:1 to SII-ChAdOx1 nCoV-19 or placebo (safety cohort n = 1,200). Immunogenicity was measured by anti-severe acute respiratory syndrome coronavirus 2 spike (anti-S) binding immunoglobulin G and neutralizing antibody (nAb) titers. A decline in anti-S titers was observed in both vaccine groups, albeit with a greater decline in SII-ChAdOx1 nCoV-19 vaccinees (geometric mean titer [GMT] ratio [95% confidence interval (CI) of SII-ChAdOx1 nCoV-19 to AZD1222]: 0.60 [0.41-0.87]). Consistent similar decreases in nAb titers were observed between vaccine groups (GMT ratio [95% CI]: 0.88 [0.44-1.73]). No cases of severe COVID-19 were reported following vaccination, while one case was observed in the placebo group. No causally related serious adverse events were reported through 180 days. No thromboembolic or autoimmune adverse events of special interest were reported. Collectively, these data illustrate that SII-ChAdOx1 nCoV-19 maintained a high level of immunogenicity 6 months post-vaccination. SII-ChAdOx1 nCoV-19 was safe and well tolerated.

AZD1222(ChAdOx1 nCoV-19)是一种复制缺陷型腺病毒载体冠状病毒病-19(COVID-19)疫苗,由印度血清研究所有限公司(Serum Institute of India Pvt Ltd)根据牛津大学/阿斯利康公司(Oxford University/AstraZeneca)的技术转让生产,名为 SII-ChAdOx1 nCoV-19。SII-ChAdOx1 nCoV-19 与 AZD1222 的非劣效性先前已在一项观察盲、2/3 期免疫桥接研究中得到证实(试验登记:CTRI/2020/08/027170)。在首次接种后 6 个月(第 180 天)的免疫原性和安全性数据分析中,1,601 名参与者按 3:1 的比例随机接种了 SII-ChAdOx1 nCoV-19 或 AZD1222(免疫原性/反应原性队列 n = 401),并按 3:1 的比例随机接种了 SII-ChAdOx1 nCoV-19 或安慰剂(安全性队列 n = 1,200)。免疫原性通过抗严重急性呼吸系统综合征冠状病毒 2 尖峰(抗-S)结合免疫球蛋白 G 和中和抗体(nAb)滴度来测定。两组疫苗接种者的抗-S滴度均出现下降,但SII-ChAdOx1 nCoV-19接种者的下降幅度更大(几何平均滴度[GMT]比值[SII-ChAdOx1 nCoV-19与AZD1222的95%置信区间(CI)]:0.60 [0.41-0.60]] :0.60 [0.41-0.87]).不同疫苗组之间的 nAb 滴度下降幅度相似(GMT 比值[95% CI]:0.88 [0.44-1.73])。接种疫苗后未出现严重的 COVID-19 病例,而安慰剂组出现了一例。180天内未报告任何与因果关系相关的严重不良事件。没有特别值得关注的血栓栓塞或自身免疫不良事件报告。总之,这些数据表明,SII-ChAdOx1 nCoV-19 在接种后 6 个月内保持了较高的免疫原性。SII-ChAdOx1 nCoV-19 安全且耐受性良好。
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期刊
Human Vaccines & Immunotherapeutics
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