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Cost-effectiveness modeling for gender-neutral human papillomavirus vaccines: A systematic literature review. 中性人乳头瘤病毒疫苗的成本-效果模型:系统文献综述。
IF 4.1 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2025-12-01 Epub Date: 2025-07-15 DOI: 10.1080/21645515.2025.2516322
Marisa Felsher, Marcie Fisher-Borne, Tufail Malik, Nita Santpurkar, Stephan Martin, Omer Zaidi, Wei Wang, Cody Palmer

Gender-neutral vaccination (GNV) of human papillomavirus (HPV) may help reduce the transmission and incidence of HPV-related diseases. However, approximately 40 countries have implemented HPV GNV schedules. We systematically evaluated HPV GNV cost-effectiveness models from January 2008 to May 2024 using MEDLINE, Embase, and Cochrane to identify key drivers of cost-effectiveness results. Fifty-three publications were included, primarily from high-income countries. Vaccine coverage, price, protection duration, and discount rates impacted cost-effectiveness, with lower prices and protection against HPV-related diseases resulting in cost-effective results. Results in models that included adults (≥18 years) were mixed and dependent on price, inclusion of non-cervical HPV-related diseases, and age groups considered. We conclude that HPV GNV can be a cost-effective strategy for preventing HPV-related diseases. However, its cost-effectiveness is highly dependent on vaccine coverage, price, and inclusion of non-cervical HPV-related diseases in models. Further economic evaluations of HPV GNV in low- and middle-income countries are recommended.

人乳头瘤病毒(HPV)的性别中立疫苗接种(GNV)可能有助于减少HPV相关疾病的传播和发病率。然而,大约有40个国家实施了HPV GNV时间表。从2008年1月到2024年5月,我们使用MEDLINE、Embase和Cochrane系统地评估了HPV GNV成本效益模型,以确定成本效益结果的关键驱动因素。其中包括53份出版物,主要来自高收入国家。疫苗覆盖率、价格、保护期和折扣率影响了成本效益,较低的价格和对hpv相关疾病的保护产生了成本效益的结果。纳入成人(≥18岁)的模型的结果是混合的,并且取决于价格、纳入的非宫颈hpv相关疾病和考虑的年龄组。我们得出结论,HPV GNV可能是预防HPV相关疾病的成本效益策略。然而,其成本效益在很大程度上取决于疫苗覆盖率、价格以及在模型中纳入非宫颈hpv相关疾病。建议在低收入和中等收入国家对HPV GNV进行进一步的经济评估。
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引用次数: 0
Economic evaluations of vaccines against respiratory infections in adults in Southeast Asia: A systematic review. 东南亚成人呼吸道感染疫苗的经济评价:系统综述。
IF 4.1 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2025-12-01 Epub Date: 2025-07-15 DOI: 10.1080/21645515.2025.2528409
Ba Khuong Cao, Rachmadianti Sukma Hanifa, Thi-Phuong-Lan Nguyen, Maarten J Postma, Jurjen van der Schans

Respiratory infections significantly impact adult health in Southeast Asia, yet vaccine coverage remains low. This systematic review evaluated the economic evaluations of vaccines targeting respiratory infections in the region. A comprehensive search was conducted across several databases, including MEDLINE/PubMed, EMBASE, NHSEED, CINAHL, EconLit, Web of Science, Scopus, and Cochrane Library, up to April 24, 2024. Nineteen eligible studies were identified, focusing primarily on influenza (8 studies) and COVID-19 vaccines (7 studies), with fewer studies on pneumococcal (2 studies), varicella (1 study), and pertussis (1 study) vaccines. Overall, influenza, COVID-19 (boosters), and pneumococcal vaccines were found to be cost-effective or highly cost-effective compared to no-vaccine or no-booster scenarios. The only study on maternal pertussis vaccination found it not to be cost-effective. The most common parameters considered in sensitivity analyses were vaccine efficacy and discount rates. This review highlights the economic evaluations of influenza, COVID-19, and pneumococcal vaccines in Southeast Asia, providing essential evidence to guide vaccine policy. Future studies should address limitations in model selection, incorporate herd immunity, ensure the model validation (i.e. validity of cost and benefit measurements), and explore the cost-effectiveness of other vaccines across the region.

呼吸道感染严重影响东南亚成年人的健康,但疫苗覆盖率仍然很低。本系统综述评估了该地区针对呼吸道感染的疫苗的经济评价。全面检索了几个数据库,包括MEDLINE/PubMed, EMBASE, NHSEED, CINAHL, EconLit, Web of Science, Scopus和Cochrane Library,截止到2024年4月24日。我们确定了19项符合条件的研究,主要关注流感(8项研究)和COVID-19疫苗(7项研究),较少关注肺炎球菌(2项研究)、水痘(1项研究)和百日咳(1项研究)疫苗。总体而言,与不接种疫苗或不接种加强剂的情况相比,流感疫苗、COVID-19(加强剂)和肺炎球菌疫苗具有成本效益或高度成本效益。唯一一项关于母亲百日咳疫苗接种的研究发现它不具有成本效益。敏感性分析中最常考虑的参数是疫苗效力和贴现率。本综述重点介绍了东南亚对流感、COVID-19和肺炎球菌疫苗的经济评估,为指导疫苗政策提供了重要证据。未来的研究应解决模型选择的局限性,纳入群体免疫,确保模型验证(即成本和效益测量的有效性),并探索该地区其他疫苗的成本效益。
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引用次数: 0
Safety, immunogenicity and pregnancy outcomes in mothers and infants after vaccination with an adenovirus-vector COVID-19 vaccine during pregnancy. 妊娠期接种腺病毒载体COVID-19疫苗后母婴的安全性、免疫原性和妊娠结局
IF 3.5 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2025-12-01 Epub Date: 2025-08-13 DOI: 10.1080/21645515.2025.2538340
Gloria Aguilar, Gabriela Tapia-Calle, Cynthia Robinson, Benoit Baron, David Lowson, Bassem Maximos, Veronica V Rezelj, Anne Marit de Groot, Nicole Bet, Vitalija van Paassen, Mathieu Le Gars, Frank Struyf, Javier Ruiz-Guiñazú

COVID-19 during pregnancy can be associated with adverse pregnancy and infant outcomes. We assessed the safety, reactogenicity, and immunogenicity of maternal vaccination with Ad26.COV2.S COVID-19 vaccine and monitored serum and breast milk antibody levels in mothers and infants until 6 months post-delivery. This open-label Phase 2 study enrolled previously COVID-19 vaccinated or COVID-19-vaccine-naive healthy pregnant women in trimester two or three (NCT04765384). All women received a single dose of Ad26.COV2.S. Mothers and infants were followed-up for safety until 1-year post-partum and for immunogenicity, including antibodies in breast milk, until 6 months post-partum. Recruitment was stopped at 51 participants due to rapidity of roll-out of COVID-19 vaccines recommended during pregnancy. Ad26.COV2.S was well-tolerated regardless of previous COVID-19 vaccination history. All pregnancies resulted in a live infant, four were preterm. One serious adverse event of placental insufficiency Day-36 post-vaccination was considered vaccine-related by the investigator. One infant died due to complications associated with an unrelated ventricular septal defect. Ad26.COV2.S induced robust immune responses in women with different COVID-19 vaccination histories. Spike-binding antibody (SAbs) and virus neutralizing antibody (NAbs) titers at delivery tended to be higher in mothers vaccinated during trimester three. Maternal serum and cord blood were strongly correlated. 100% of infants had detectable SAbs at aged 6 months, and 70.6% had detectable NAbs, including 68.2% born to initially vaccine-naïve mothers. Maternal vaccination with an adenovirus-vector vaccine was well-tolerated and immunogenic in mothers and infants. These data could support the adoption of heterologous booster regimens during pregnancy and future adenovirus-vector vaccine development.

妊娠期间感染COVID-19可能与不良妊娠和婴儿结局有关。我们评估了母体接种Ad26.COV2疫苗的安全性、反应原性和免疫原性。并监测母亲和婴儿的血清和母乳抗体水平,直至分娩后6个月。这项开放标签ii期研究招募了之前接种过COVID-19疫苗或未接种过COVID-19疫苗的妊娠2或3个月的健康孕妇(NCT04765384)。所有女性均接受单剂Ad26.COV2.S。对母亲和婴儿进行安全随访,直到产后1年,并对免疫原性进行随访,包括母乳中的抗体,直到产后6个月。由于在怀孕期间推荐的COVID-19疫苗的快速推广,招募工作在51名参与者中停止。Ad26.COV2。不论之前是否有COVID-19疫苗接种史,S耐受良好。所有怀孕结果都是一个活婴,其中四个是早产。接种疫苗后第36天发生的胎盘功能不全的严重不良事件被研究者认为与疫苗有关。一名婴儿死于与不相关的室间隔缺损相关的并发症。Ad26.COV2。S在不同COVID-19疫苗接种史的妇女中诱导了强大的免疫反应。在分娩时,钉结合抗体(SAbs)和病毒中和抗体(nab)滴度在妊娠3个月期间接种疫苗的母亲中趋于较高。母体血清与脐带血呈强相关。100%的婴儿在6个月大时可检测到sab, 70.6%的婴儿可检测到nab,其中68.2%的婴儿出生时母亲为vaccine-naïve。母亲接种腺病毒载体疫苗对母亲和婴儿具有良好的耐受性和免疫原性。这些数据可以支持在怀孕期间采用异源加强方案和未来的腺病毒载体疫苗的开发。
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引用次数: 0
Willingness to pay for herpes zoster vaccination in urban China. 中国城市居民购买带状疱疹疫苗的意愿。
IF 3.5 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2025-12-01 Epub Date: 2025-09-15 DOI: 10.1080/21645515.2025.2559510
Yanran Wang, Ming Wang, Yiqi Xia, Dawei Zhu, Zhenyu Shi, Ping He

Herpes zoster imposes a substantial disease burden in China. Despite vaccination being critical for burden mitigation, willingness-to-pay (WTP) for herpes zoster vaccines among urban residents remains understudied, with a lack of national-level evidence on its determinants. A national-wide survey was conducted among 2,864 urban residents aged ≥25 years across nine provinces and nine cities in China. Using the contingent valuation method (CVM), three elicitation approaches - payment scales, bidding, and open-ended questions - were employed to assess respondents' willingness-to-pay (WTP) for herpes zoster vaccination. Univariate statistical analyses were then performed to explore the associations between socioeconomic characteristics and WTP. Median WTP varied by methods (payment cards: CNY 300, bidding: CNY 500, open-ended: CNY 300). Across these methods, 36.09%, 29.06%, and 23.64% of participants, respectively, were unwilling to pay (including those rejecting free vaccination). For higher thresholds, 2.36% and 9.96% reported WTP ≥ 2,000 CNY via the payment scale and bidding methods, while 2.09% indicated WTP ≥ 2,000 CNY through the open-ended method. Age was negatively associated with WTP, and respondents from moderately developed regions had the highest WTP. Education and annual household income showed positive associations with WTP. Additionally, unemployment, chronic disease, divorced or widowed residents, and below-average self-reported health correlated with lower WTP. While respondents with public or commercial insurance had highest WTP. In conclusion, individual WTP for herpes zoster vaccine is substantially influenced by socioeconomic characteristics, which are inherently linked to income. This highlights the need for income-sensitive policies, including affordable pricing and targeted health education for vulnerable groups.

带状疱疹在中国造成了巨大的疾病负担。尽管疫苗接种对减轻负担至关重要,但城市居民对带状疱疹疫苗的支付意愿(WTP)仍未得到充分研究,缺乏关于其决定因素的国家级证据。一项全国性的调查在中国9个省和9个城市对2864名年龄≥25岁的城市居民进行了调查。采用条件评估法(CVM),采用三种启发方法——支付量表、竞价和开放式问题——来评估受访者对带状疱疹疫苗接种的支付意愿(WTP)。然后进行单变量统计分析,探讨社会经济特征与WTP之间的关系。WTP中位数因方式而异(支付卡:300元,竞价:500元,开放式:300元)。在这些方法中,分别有36.09%、29.06%和23.64%的参与者不愿意付费(包括拒绝免费疫苗接种的参与者)。对于较高的阈值,分别有2.36%和9.96%的受访者通过支付规模和招标方式表示WTP≥2000元,2.09%的受访者通过开放式方式表示WTP≥2000元。年龄与WTP呈负相关,中等发达地区的受访者WTP最高。教育程度、家庭年收入与WTP呈显著正相关。此外,失业、慢性病、离婚或丧偶居民以及低于平均水平的自我报告健康状况与较低的WTP相关。而拥有公共或商业保险的受访者WTP最高。总之,带状疱疹疫苗的个人WTP在很大程度上受到社会经济特征的影响,而社会经济特征与收入有着内在的联系。这突出表明需要制定对收入敏感的政策,包括负担得起的价格和针对弱势群体的保健教育。
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引用次数: 0
High coverage with delayed doses: Cross-sectional study of parental acceptance and uptake of varicella vaccination in children aged 4-12 years in Chaoyang District, Beijing. 延迟剂量的高覆盖率:北京市朝阳区4-12岁儿童水痘疫苗父母接受和吸收的横断面研究
IF 3.5 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2025-12-01 Epub Date: 2025-09-15 DOI: 10.1080/21645515.2025.2558271
Yang Cao, Xinyu Li, Ziwei Zhao, Zhen Li, Fang Liu, Pu Liu, Jianxin Ma, Qian Shi, Nan Zhang, Bin Jia

Regional disparities exist in China's varicella vaccination policies, with Beijing's voluntary two-dose program requiring self-payment having been implemented for more than a decade. In this study, we investigated parental acceptance and vaccination patterns among 2,189 children aged 4-12 years in Beijing's Chaoyang District, where policy integration is under consideration. The results revealed high baseline vaccination willingness (81.8%), potentially increasing to 86.3% with inclusion of an immunization program. Key determinants extended beyond demographic factors and disease knowledge to include parental satisfaction with immunization services and utilization of parenting apps. Current coverage rates were 74.5% for the first dose (VarV1) versus 53.2% for the second dose (VarV2), indicating significant second-dose attrition. Primary barriers to vaccination included limited awareness of the option to vaccinate, safety concerns, and perceptions that a single dose offers sufficient protection. Notably, 58.8% of children received VarV1 later than the recommended schedule, partly due to vaccination scheduling. School-based verification requirements emerged as a critical driver of compliance. Our study provides actionable insights for immunization policy optimization. We advocate targeted communication strategies via new media platforms, such as parenting apps, to address knowledge gaps, emphasize two-dose protocols, and boost vaccine confidence. This approach fosters a cycle of tool usage, knowledge acquisition, and timely vaccination, leveraging the demonstrated synergy between app usage and vaccine knowledge in enhancing adherence.

中国的水痘疫苗接种政策存在地区差异,北京的自愿两剂计划要求自费,已经实施了十多年。本研究以北京市朝阳区2189名4-12岁儿童为研究对象,调查了父母对疫苗接种的接受程度和接种模式。结果显示基线疫苗接种意愿很高(81.8%),纳入免疫规划后可能增加到86.3%。关键决定因素超出了人口因素和疾病知识,还包括父母对免疫服务的满意度和育儿应用程序的使用情况。目前第一剂(VarV1)的覆盖率为74.5%,第二剂(VarV2)的覆盖率为53.2%,这表明第二剂的明显损耗。接种疫苗的主要障碍包括对疫苗选择的认识有限、安全问题以及认为单剂接种就能提供足够的保护。值得注意的是,58.8%的儿童接种v1疫苗的时间晚于推荐的接种时间,部分原因是疫苗接种计划不合理。以学校为基础的核查要求成为遵守规定的关键驱动因素。我们的研究为免疫政策优化提供了可行的见解。我们倡导通过育儿app等新媒体平台,采取有针对性的传播策略,以弥补知识空白,强调两剂方案,增强疫苗信心。这种方法促进了工具使用、知识获取和及时接种疫苗的循环,利用应用程序使用和疫苗知识之间已证明的协同作用,提高了依从性。
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引用次数: 0
Identification of multifunctional T-cell peptide epitopes for the development of DNA vaccines against dengue virus. 登革病毒DNA疫苗中多功能t细胞肽表位的鉴定。
IF 3.5 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2025-12-01 Epub Date: 2025-09-09 DOI: 10.1080/21645515.2025.2557097
Ningze Sun, Zhiwei Su, Chenghong Yin, Xiaoyan Zheng

Dengue virus (DENV) is an important arthropod-borne virus that poses a global health threat, with half of the world's population at risk of infection. Currently, there is a lack of safe and effective vaccines for its prevention. Antibody-dependent enhancement (ADE) occurs when cross-reactive antibodies fail to neutralize heterologous DENV serotypes effectively, facilitating viral entry into Fc receptor-bearing cells and leading to more severe disease. It is reported that multifunctional T cells are closely related to the protective effects of the vaccine. We selected 25 peptide candidates based on predictions from the IEDB database and relevant literature. These peptides were validated to stimulate the production of multifunctional T cells. The DNA sequences of the corresponding peptides were cloned into the pVAX1 vector, and monovalent DNA vaccines for DENV 1-4 were constructed. We analyzed cellular immunity, symptom scores, body weight changes, and survival rates after DENV challenge with the identical immunizing strain.Our studies confirmed that DNA vaccines can protect mice against DENV challenge. Compared with control groups, mice immunized with our DNA vaccines demonstrated better immune protection after being challenged with the corresponding strain of DENV. Our studies provide a basis for the development of new DENV tetravalent vaccines.

登革热病毒(DENV)是一种重要的节肢动物传播病毒,对全球健康构成威胁,世界上一半的人口面临感染风险。目前,缺乏安全有效的预防疫苗。当交叉反应性抗体不能有效中和异源DENV血清型时,就会发生抗体依赖性增强(ADE),从而促进病毒进入携带Fc受体的细胞并导致更严重的疾病。据报道,多功能T细胞与疫苗的保护作用密切相关。我们根据IEDB数据库和相关文献的预测选择了25个候选肽。这些肽被证实可以刺激多功能T细胞的产生。将相应肽段的DNA序列克隆到pVAX1载体上,构建DENV 1-4单价DNA疫苗。我们分析了细胞免疫、症状评分、体重变化和DENV攻击后相同免疫株的存活率。我们的研究证实,DNA疫苗可以保护小鼠免受DENV的攻击。与对照组相比,用我们的DNA疫苗免疫的小鼠在受到DENV相应菌株的攻击后表现出更好的免疫保护。本研究为DENV新型四价疫苗的研制提供了基础。
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引用次数: 0
In vivo CAR-T cell therapy: New breakthroughs for cell-based tumor immunotherapy. 体内CAR-T细胞疗法:基于细胞的肿瘤免疫治疗的新突破。
IF 3.5 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2025-12-01 Epub Date: 2025-09-11 DOI: 10.1080/21645515.2025.2558403
Yifan Huang, Rong Cao, Siyang Wang, Xinfeng Chen, Yu Ping, Yi Zhang

Chimeric antigen receptor (CAR)-T cell immunotherapy represents an evolutionary advance in the treatment of cancer, yet it faces challenges such as manufacturing complexity, high cost, and time-consuming process. In recent years, the strategy of in vivo CAR-T cell therapy is emerging as a promising approach to improve anti-tumor effectiveness and safety. Briefly, T cells are genetically modified to express CAR protein directly in the body by delivery of vectors. With the continuous optimization of gene delivery systems, gene editing technologies and CAR structures, advancements in in vivo CAR-T therapies have notably enhanced safety, effectiveness, and application in clinical settings. Here, we review the key platforms of in vivo gene delivery and the progress of in vivo CAR-T cell therapy for cancers. We discuss the challenges of in vivo CAR-T cell therapy, such as safety issues of gene delivery, the persistence and function of CAR-T cell, and the immunosuppressive microenvironment in solid tumors.

嵌合抗原受体(CAR)-T细胞免疫疗法代表了癌症治疗的进化进步,但它面临着制造复杂、成本高、耗时等挑战。近年来,体内CAR-T细胞治疗策略正成为一种有希望提高抗肿瘤有效性和安全性的方法。简而言之,T细胞经过基因修饰,通过载体的传递直接在体内表达CAR蛋白。随着基因传递系统、基因编辑技术和CAR结构的不断优化,体内CAR- t疗法的进展显著提高了安全性、有效性和临床应用。在此,我们综述了体内基因传递的关键平台和体内CAR-T细胞治疗癌症的进展。我们讨论了体内CAR-T细胞治疗的挑战,如基因传递的安全性问题,CAR-T细胞的持久性和功能,以及实体肿瘤中的免疫抑制微环境。
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引用次数: 0
Human vaccines and immunotherapeutics: News September 2025. 人类疫苗和免疫疗法:新闻2025年9月。
IF 3.5 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2025-12-01 Epub Date: 2025-10-07 DOI: 10.1080/21645515.2025.2571369
Ronald Ellis, Adam Weiss
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引用次数: 0
A multi-disciplinary exploration of the press review of the Italian National Institute of Health during the COVID-19 pandemic. COVID-19大流行期间意大利国家卫生研究所新闻评论的多学科探索
IF 3.5 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2025-12-01 Epub Date: 2025-10-14 DOI: 10.1080/21645515.2025.2567680
Carlotta Fiammenghi, Elisabetta Ceretti, Loredana Covolo, Nicola Pelizzari, Mirella Anna Taranto, Luana Penna, Laura Brunelli, Silvio Brusaferro, Umberto Gelatti

This study examines how Italian national newspapers portrayed COVID-19 vaccines during 2020-2021. A corpus of 5,621 articles from seven newspapers, collected via the Italian National Institute of Health's daily press review, was analyzed with SketchEngine using corpus-assisted discourse methods. Quantitative analysis showed a rise in vaccine-related coverage at the end of 2020 and throughout 2021. Core terms such as vaccino (vaccine) and vaccinazione (vaccination) were frequent, while occasional use of synonyms like serum and antidote risked creating confusion. Qualitative analysis revealed instances of "false balance," where anti-vaccine views were presented alongside pro-vaccine perspectives as if equally supported by evidence. These findings suggest that even authoritative outlets reproduced reporting practices that may undermine public understanding of vaccines. Greater awareness of such practices, and closer collaboration between health professionals and communication experts, could help improve the quality of health information in the media.

本研究调查了意大利国家报纸在2020-2021年期间如何描述COVID-19疫苗。通过意大利国家卫生研究所的每日新闻评论收集了来自七家报纸的5,621篇文章的语料库,使用SketchEngine使用语料库辅助话语方法进行了分析。定量分析显示,在2020年底和2021年全年,疫苗相关覆盖率有所上升。核心术语如vaccino(疫苗)和vaccinazione(疫苗)频繁出现,而偶尔使用的同义词如serum和antidote可能会造成混淆。定性分析揭示了“虚假平衡”的例子,即反对疫苗的观点与支持疫苗的观点同时出现,似乎得到了同样的证据支持。这些发现表明,即使是权威机构也会重复可能破坏公众对疫苗理解的报道做法。提高对这种做法的认识,并加强卫生专业人员和传播专家之间的合作,可以帮助提高媒体中卫生信息的质量。
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引用次数: 0
Safety and immunogenicity of a tetravalent dengue vaccine (CYD-TDV) in HIV-positive adults aged 18-50 years in Brazil: Results from a phase II, randomized, observer-blind, placebo-controlled trial. 四价登革热疫苗(CYD-TDV)在巴西18-50岁艾滋病毒阳性成人中的安全性和免疫原性:来自II期随机、观察者盲、安慰剂对照试验的结果。
IF 3.5 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2025-12-01 Epub Date: 2025-11-10 DOI: 10.1080/21645515.2025.2582237
Ana Perroud, José Valdez Ramalho Madruga, Luis Fernandes, Kleber Luz, Nemanja Lukic, Sophie Bourée, Martin Sanchez-Ruiz, Fabiana Pegoraro, Celine Petit, Betzana Zambrano, Gustavo Dayan

Dengue is a common arboviral infection that poses a serious health concern worldwide, including Latin America. Our study assessed the safety and immunogenicity of CYD-TDV, a recombinant, live-attenuated, tetravalent dengue vaccine, among HIV-infected adults in Brazil, with previous exposure to dengue infection, and maintained on antiretroviral therapy. This observer-blind, placebo controlled, phase II study (NCT02741128) enrolled participants aged 18-50 years, randomized 2:1 to receive CYD-TDV or placebo subcutaneously at 0, 6, and 12 months. Serological assessments were performed using plaque reduction neutralization assays at baseline and 28 days following each vaccination. Overall, 133 participants were randomized (CYD-TDV, n = 89; placebo, n = 44). At day 28, post-initial vaccination, participants receiving CYD-TDV reported 3.11- to 6.37-fold increase in neutralizing antibody geometric mean titers compared with those at baseline across dengue virus serotypes 1-4 but were sustained after 3 doses. No notable immune responses were observed to any of the serotypes in the placebo group. The safety profiles were comparable across both study groups. In the CYD-TDV and placebo groups, pain was the most commonly reported injection site reaction post-first injection in 18.4% and 29.5% participants, respectively. There were no reports of Grade 3 solicited injection site reactions post-CYD-TDV administration. No safety signals were detected after CYD-TDV administration, including immediate unsolicited AEs/ARs, SAEs/AESIs, or HIV-related conditions. None of the participants discontinued the study due to an AE, and no deaths were reported. CYD-TDV demonstrated adequate safety and robust immunogenicity against all dengue serotypes in HIV-positive adults receiving prior antiretroviral treatment.

登革热是一种常见的虫媒病毒感染,在包括拉丁美洲在内的世界范围内构成严重的健康问题。我们的研究评估了CYD-TDV的安全性和免疫原性,CYD-TDV是一种重组、减毒、四价登革热疫苗,在巴西感染hiv的成年人中,以前暴露于登革热感染,并持续抗逆转录病毒治疗。这项观察盲、安慰剂对照的II期研究(NCT02741128)招募了年龄在18-50岁的参与者,随机分为2:1,分别在0、6和12个月接受CYD-TDV或安慰剂皮下注射。在每次接种疫苗后的基线和28天,使用斑块减少中和试验进行血清学评估。总体而言,133名参与者被随机分配(CYD-TDV, n = 89;安慰剂,n = 44)。在初次接种疫苗后的第28天,接受CYD-TDV的参与者报告,与基线时相比,中和抗体几何平均滴度增加了3.11至6.37倍,这些抗体在登革热病毒血清型1-4之后持续了3次剂量。在安慰剂组中,没有观察到对任何血清型的显著免疫反应。两个研究组的安全性具有可比性。在CYD-TDV组和安慰剂组中,疼痛是首次注射后最常见的注射部位反应,分别为18.4%和29.5%的参与者。cyd - tdv给药后没有3级征求性注射部位反应的报道。服用CYD-TDV后未检测到安全信号,包括立即未经请求的ae /ARs, sae /AESIs或hiv相关情况。没有参与者因AE而中止研究,也没有死亡报告。在接受过抗逆转录病毒治疗的hiv阳性成人中,CYD-TDV显示出足够的安全性和对所有登革热血清型的强大免疫原性。
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Human Vaccines & Immunotherapeutics
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