Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine (Butantan-DV) in Patients With Autoimmune Rheumatic Diseases Living in Dengue-Endemic Areas

The goal of this clinical trial is to evaluate whether the live attenuated tetravalent Butantan-Dengue vaccine (Butantan-DV) is safe and capable of inducing an immune response in patients aged 12 to 59 years with autoimmune rheumatic diseases (ARDs) who are clinically stable and under low-grade or no immunosuppression, as well as in healthy volunteers matched by sex and age.
The main questions it aims to answer are:
Does the vaccine induce adequate seroconversion in patients with ARDs compared to healthy controls? What is the frequency and intensity of common adverse events after vaccination in ARDs patients? Does physical activity levels and nutritional status influence vaccine-induced immune response in patients with ARDs?
Researchers will compare patients with ARDs to healthy controls to evaluate if the vaccine elicits similar immune responses and safety profiles.
All participants will:
* receive a single 0.5 mL dose of the Butantan-DV vaccine via subcutaneous injection;
* undergo blood sample collection before and after vaccination (baseline, Day 42, and Day 400) to assess antibody and cellular responses;
* attend follow-up visits on Days 7, 14, and 42 for safety monitoring and laboratory tests;
* report any symptoms or adverse events using a standardized diary for 42 days;
* be followed for up to one year for long-term safety and immunogenicity assessments.
* wear a device for 14 consecutive days to assess current and habitual physical activity levels.
* answer three non-consecutive 24-hour dietary recalls, including at least one weekend day to assess nutritional status.
* collect blood samples one-year after vaccination to access immunogenicity and cellular response.
Researcher will also perform subgroups analysis in:
A viremia subgroup (50 patients and 50 healthy controls) will provide additional samples on Days 1, 7, 14, 28, 42, and-if viremia is detected-Day 68, to evaluate post-vaccination viremia and its duration.
An immunogenicity subgroup (
20% of participants, n=96) will undergo cellular immune response testing via flow cytometry to evaluate T-cell responses.

开始日期2026-01-15

申办/合作机构

University of Sao Paulo General Hospital

[+1]

NCT06891950

/ Not yet recruiting临床3期IIT

Phase 3B, Double-blind, Randomized Study to Evaluate the Safety and Non-inferiority of the Humoral Immune Response of the Butantan Dengue Vaccine in Participants Aged 60 to 79 Years Compared to Participants Aged 40 to 59 Years

This is a randomized, double-blind (60 -79 years) and open-label (40-59 years), three-arm parallel Phase 3b, multicenter study to evaluate the safety and non-inferiority of the humoral immune response of the Butantan Dengue vaccine (Dengue 1,2,3,4 (attenuated)) in participants aged 60 -79 years (elderly) compared to participants aged 40 to 59 years (adults), with or without previous dengue and healthy based on clinical examination.

开始日期2026-01-01

申办/合作机构

Instituto Butantan

[+1]

NCT06805487

/ Recruiting临床1期IIT

A Phase 1 Evaluation of the Protective Efficacy of a Single Dose of the Live Attenuated Tetravalent Dengue Vaccine TV003 or Previous Zika Infection Against Infection With ZIKV-SJRP Challenge Compared to DENV and ZIKV-naïve Historical Controls Against Infection With ZIKV-SJRP Challenge

Zika virus (ZIKV) is an illness people can get from mosquitoes. The infection is generally mild with symptoms that include a fever, rash, red eyes, and joint pain, though most of those infected have no symptoms. Preventing ZIKV is important because if a pregnant person is infected with ZIKV, it can cause birth defects in their unborn child.
The goals of this study are to find out if people who have already been infected with one type of ZIKV can get infected with ZIKV a second time, and to test the ability of the TV003 dengue vaccine to prevent people from getting infected with the ZIKV-SJRP challenge virus.

开始日期2024-09-24

申办/合作机构

National Institute of Allergy & Infectious Diseases

[+1]

100 项与 Tetravalent dengue virus vaccine(Instituto Butantan) 相关的临床结果

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100 项与 Tetravalent dengue virus vaccine(Instituto Butantan) 相关的转化医学

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100 项与 Tetravalent dengue virus vaccine(Instituto Butantan) 相关的专利（医药）

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项与 Tetravalent dengue virus vaccine(Instituto Butantan) 相关的文献（医药）

2026-05-01·JOURNAL OF VIROLOGICAL METHODS

Animal models illuminate dengue immunopathogenesis to guide vaccine and therapeutic developments

Review

作者: Shabbir, Muhammad Nadir ; Linh, Duong Thuy

Dengue virus (DENV) infection affects over 390 million people annually, and its severe forms, including dengue hemorrhagic fever (DHF) and dengue shock syndrome (DSS), occur as a result of antibody-dependent enhancement (ADE), T-cell dysregulation, and a cytokine storm. This review integrates the results of human immunopathology with those reported by animal models, consolidating the findings in a systematic manner to validate these mechanisms. Research on AG129 interferon receptor-deficient mice consistently demonstrates ADE-mediated viremia and vascular leakage. However, humanized NSG-BLT mice recapitulate the classic antigenic sin of human T cells after heterotypic challenge with DENV. Cynomolgus macaque models are physiologically relevant for testing tetravalent vaccines under near-human circulatory conditions, and diet-induced obese mice are used to phenotype the effects of metabolic comorbidities on IL-1β-driven immunopathology. Data using standardized methods, including Evans blue extravasation assays, multiplex cytokine panels, and endpoints compliant with the ARRIVE 2.0 guidelines for animal research reporting, were associated with human clinical results. ARRIVE 2.0 is a set of guidelines to improve the transparency and reproducibility of animal research. It is worth noting that early experimental studies on the effectiveness and safety of Dengvaxia reported breakthrough viremia in macaque models. The protection provided by the monoclonal antibody C10 was shown to mitigate antibody-dependent enhancement (ADE) in murine models, though it is not associated with the Dengvaxia vaccine. The further development of these animal models will be necessary to expedite the safe development of next-generation dengue vaccines (TAK-003, TV003/TV005), antivirals (favipiravir, sofosbuvir), and immune modulators (IL-6 and TNF-α blockers) for use in endemic areas.

2026-01-01·Lancet regional health. Americas

Dengue virus genetic diversity in unvaccinated and vaccinated dengue-infected individuals: an observational analysis of the Butantan-DV phase 3 trial in Brazil

Article

作者: Miranda, Érique ; Boulos, Fernanda Castro ; Bernardi, Victoria ; Dos Santos, Cecília Luiza Simões ; Teixeira, Mauro Martins ; Boaventura, Viviane Sampaio ; Marques, Beatriz de Carvalho ; Kallás, Esper Georges ; Pereira, Dhelio Batista ; Nogueira, Maurício Lacerda ; de Moraes, José Cassio ; Banho, Cecília Artico ; Estofolete, Cássia Fernanda ; Fontes, Cor Jesus Fernandes ; Gurgel, Ricardo Queiroz ; Coelho, Ivo Castelo-Branco ; Moreira, José Alfredo de Sousa ; Romero, Gustavo Adolfo Sierra ; Ramos, Fabiano ; de Lacerda, Marcus Vinícius Guimarães ; de Siqueira, André Machado ; Marques Júnior, Ernesto Torres de Azevedo ; Elias Júnior, Erivaldo ; Sacchetto, Lívia ; Freitas, Angela Carvalho ; da Fonseca, Allex Jardim ; Timenetsky, Maria do Carmo Sampaio Tavares ; Vasilakis, Nikos

Background:

Dengue has emerged as a public health challenge in Brazil since the early 1980s, and it is currently one of the most affected regions and an epicenter of the disease. The country faced its worst dengue epidemic on record, with the co-circulation of different dengue virus (DENV) serotypes alongside genotypes and lineages. This scenario stresses the urgent need for a vaccination strategy that addresses the current burden by protecting against all four DENV serotypes and ensuring safety despite a history of dengue exposure, given the high seroprevalence of dengue in Brazil.

Methods:

In this study, we analyzed 365 DENV-1 and DENV-2 wild-type positive samples from unvaccinated and vaccinated (28 days post-vaccination) dengue-infected participants enrolled in the Butantan-dengue vaccine (Butantan-DV) phase 3 trial conducted in Brazil from 2016 to 2021. Genome sequences were obtained from 160 samples in order to analyze the genetic diversity of these strains through phylogenetic and genomic studies.

Findings:

The 365 participants (mean age: 16.6, range: 2-59; male: 52.3%, female: 47.7%) enrolled and tested positive for DENV-1 and DENV-2 from both groups (vaccinated and placebo) reflected the spatial and epidemic patterns recorded in the country during the study period. Despite the limited statistical power due to the low number of samples, we observed significantly lower RT-qPCR Ct values in the vaccinated group, particularly for the DENV-1 cases, suggesting that the vaccine could be reducing viral replication. Additionally, vaccine breakthrough infections were not linked with any specific DENV-1 or DENV-2 lineage. Genetic diversity analysis showed no differences in intra-host synonymous or non-synonymous mutation rates between the groups, combined with the absence of positive selection sites in the DENV-1 and DENV-2 coding regions.

Interpretation:

Our phylogenetic data demonstrate that Butantan-DV breakthrough infections is not linked to any unique DENV-1 or DENV-2 lineages. The circulating strains in both groups reflect typical transmission patterns of both viruses, highlighting instances of co-circulation and lineage replacement. Notably, the absence of positive selection sites and stable synonymous/non-synonymous mutation rates provides suggestive evidence that the vaccine does not promote vaccine-driven adaptive evolution.

Funding:

Instituto Butantan, National Institutes of Health, National Council for Science and Technology and Fundação de Amparo à Pesquisa do Estado de Minas Gerais, Instituto Nacional de Ciência e Tecnologia em Dengue (INCT), INCT Viral Genomic Surveillance and One Health, São Paulo Research Foundation.

2025-11-25·Gaceta Medica de Mexico

Immunogenicity and safety of tetravalent dengue vaccines: a systematic review of clinical trials

Review

作者: Montes-Sevilla, Lenyn D ; Acosta-Gutiérrez, Gilberto H ; Morales-Hernández, Osmara ; Ramírez-García, Erick ; Flores-Reyes, Marco F ; Girón-Pérez, Manuel I ; Guzmán-Ríos, Edgar D ; Hernández-Montes, Paul E

Tetravalent dengue vaccines have been the subject of study, particularly in the prevention of severe cases of the disease. However, the variability in results and the methodological quality of existing studies raise questions about their effectiveness. The objective is to evaluate the immunogenicity and safety of tetravalent vaccines compared to placebo in the prevention of severe dengue cases through a systematic review of randomized clinical trials. A systematic search was conducted in databases PubMed, Scopus, and Web of Science, including randomized clinical trials published between 2019 and 2024. Inclusion and exclusion criteria were applied to select relevant studies, and methodological quality was assessed using the level of evidence from the Oxford Centre for Evidence-Based Medicine (OCEBM). Six randomized clinical trials were included, with a total of 24,249 participants. The studies evaluated outcomes such as the incidence of severe dengue, seropositivity, and immune response to the vaccines TV003 and TV005. Tetravalent vaccines show a promising outlook in reducing the incidence of severe dengue, although limitations were identified in study designs and heterogeneity in the studied populations. Further research is needed to confirm efficacy and safety in diverse populations.

项与 Tetravalent dengue virus vaccine(Instituto Butantan) 相关的新闻（医药）

2026-01-26

·中国病毒学英文版

综述：登革热流行现状及疫苗研发进展| VS推荐

中国病毒学英文版 IF:4.0 公众号ID：virologica 关注阅读原文 doi.org/10.1016/j.virs.2026.01.001 作者贺诗淇, 范东瀛，郭禹卿, 管宇恒，盛子洋，高娜，安静单位首都医科大学基础医学院微生物教研室摘要登革热是一种由登革病毒（DENV）引起的急性蚊媒传染病，主要流行于热带和亚热带地区。近年来，受气候变化、城市化快速发展、全球贸易扩张、国际旅行增多及病毒基因型持续进化等多重因素交织影响，全球登革热发病率显著上升，流行范围逐年扩大。自 2023 年以来，美洲、亚洲和非洲的多个国家接连报告大规模疫情，传播态势愈发迅猛。据世界卫生组织统计，2023 年全球报告登革热病例超过 500 万例，而 2024 年病例数激增至 1400 万例以上，死亡超 1 万例，创下历史最高疾病负担水平。在中国，登革热病例同样呈现明显上升趋势。2024年发生十年来最大规模登革热疫情，其中广东省占国内报告病例的主要部分。这些流行病学数据表明，登革热已成为全球范围内亟待重点防控的公共卫生威胁，疫苗研发也因此成为公共卫生领域的优先事项。目前，全球已有两种疫苗（登革热减毒活疫苗 Dengvaxia 与四价登革热疫苗 Qdenga）获批用于预防接种，另有六种候选疫苗处于临床试验阶段，其中四价减毒活疫苗 TV003/TV005 凭借优异的免疫原性和安全性，被认为是最具应用前景的候选疫苗之一。尽管疫苗研发取得显著进展，但仍面临重大挑战：需要对四种血清型诱导均衡免疫反应，同时降低抗体依赖性增强（ADE）的潜在风险。综上，本综述总结了全球及区域登革热的流行趋势、传播驱动因素与疫苗研发进展，深入分析了当前防控面临的核心挑战，为制定科学高效的登革热防控策略提供了有价值的参考。一、流行现状 1. 全球流行态势据估计，每年约有3.9亿人感染登革病毒，其中约9600万人出现临床症状，对全球公共卫生构成严峻挑战。登革热目前已在100多个国家和地区流行，主要分布于美洲、亚洲、非洲和澳大利亚的热带和亚热带地区。 2000-2019 年：全球病例数增长近 10 倍，2019 年全球报告病例约 520 万例,使全球约一半人口面临感染风险（WHO，2023a；WHO，2019b）。 2023 年：全球超 80 个国家 / 地区报告超 500 万例病例、5000 例死亡,其中美洲地区多达410万例，约占全球总数的80%(WHO, 2023a)。 2024 年：全球病例激增至 1400 万例、死亡超 1 万例，创历史峰值,病例主要集中在美洲地区(Venkatesan, 2024)。 2025 年（1-7 月）：全球97 个国家报告超 400 万例病例、3000 例死亡，传播态势未减 (WHO, 2025)。 2. 中国流行情况中国登革热流行区逐步扩大，约 1.68 亿人处于高风险区域，2014、2019、2023 年为高发年，广东省为主要流行区。 2014-2018 年：大陆共报告 59183 例本地病例（13 省 314 个区县）、5458 例输入病例（29 省 734 个区县，云南占 50%），2014 年本地病例达 46105 例 (Yue, Y. et al., 2019)。 2019-2023 年：2019 年报告 22188 例（发病率 1.57/10 万），2023 年报告 19541 例（发病率 1.38/10 万），两年占五年总病例 96.83%f (Li et al., 2024)；2020-2022 年受新冠疫情影响，仅报告 1185 例本地病例和217 例输入病例，主要分布在云南、广东和广西 (Yue, Y.J. et al., 2023a; Yue, Y.J. et al., 2023b)。 2024 年：全国共报告 24330 例，1-6 月每月病例不足 200 例，7起病例数迅速上升，10 月达峰值 11083 例；广东省 10 月报告超 8000 例，占全国多数，无死亡病例（国家疾病预防控制局，广东省疾病预防控制中心）。 2025 年（1-12 月）：全国共报告 10007 例，上半年每月病例低于 100 例，7 月后逐步上升，10 月达 3737 例（较 2024 年好转）；广东省 10 月 1-30 日报告 1610 例，占全国同期多数（国家疾病预防控制局，广东省卫生健康委员会）。图1. 2005—2024年中国本地与输入性登革热病例变化趋势。数据来源于已发表研究及国家疾病预防控制局和广东省疾病预防控制中心的官方统计。蓝线表示本地传播病例，橙线表示输入性病例。 3. 流行风险因素气候因素：全球变暖延长蚊媒活动期、加速病毒增殖；降雨增加蚊媒滋生地，影响其种群密度。登革热正向温带和高海拔地区扩散。社会因素：城市化进程加速，全球贸易与国际旅行频繁，促进病毒跨区域传播；公共卫生条件影响蚊媒生存环境。病毒因素：抗原漂移、基因型替换增强病毒传染性和扩散能力；不同血清型间的相互作用通过抗体依赖性增强（ADE）加剧病情。二、疫苗研发进展 1. 已获批疫苗 Dengvaxia（CYD-TDV）：法国赛诺菲研发的四价减毒活疫苗，基于黄热病毒 YF17D 骨架构建，需接种 3 剂（间隔0、6、12 月）。WHO建议CYD-TDV应用于 9-45 岁有既往感染史人群。整体效力中等，对 DENV-2 保护力较弱，血清阴性或 9 岁以下儿童接种可能增加重症风险。表1. 已获批及在研登革热疫苗的简要概述图2. 疫苗结构示意图 Qdenga（TAK-003）：日本武田制药研发的四价减毒活疫苗，以减毒 DENV-2（PDK-53）为骨架，需接种 2 剂（间隔 3 个月）。WHO建议TAK-003应用于高负担地区（人群血清阳性率 ≥60%）6-16 岁人群。 2. 临床试验阶段疫苗 TV003/TV005：美国 NIAID 研发的四价减毒活疫苗，通过缺失 3'UTR 核苷酸实现减毒，单剂接种即可诱导均衡免疫，TV003 已进入 III 期临床试验，在巴西的 II 期数据显示 2 年保护效力为79.6%。其他候选疫苗：包括葛兰素史克的减毒活疫苗（TDENV-LAV）和灭活疫苗（TDENV-PIV）、默沙东的重组亚单位疫苗（V180）、美国海军医学研究中心的 DNA 疫苗（TVDV）、英国 Emergex公司的金纳米颗粒肽疫苗（PepGNP-Dengue）。 3. 新兴研发技术 mRNA 疫苗：通过递送编码病毒抗原的人工设计 RNA，在体内诱导体液免疫和细胞免疫应答，并借助脂质纳米颗粒提高稳定性和递送效率。相关研究表明，mRNA-LNP 疫苗在动物模型中具有良好的免疫原性和保护效果，且可通过对关键表位的理性改造降低抗体依赖性增强效应（ADE），显示出构建安全、有效四价登革热疫苗的巨大潜力。 AI 辅助设计：AI 可用于预测和筛选关键 B 细胞与 T 细胞表位、设计多表位疫苗、优化佐剂与递送系统，并模拟病毒演化和宿主免疫反应。mRNA 技术与 AI 赋能的理性设计相结合，为克服传统疫苗局限、开发新一代安全且广谱保护的登革热疫苗提供了有力路径。本文亮点本综述总结了全球及区域登革热流行趋势和疫苗研发进展目前Dengvaxia 和 Qdenga 两款疫苗已获得临床使用许可，另有六种候选疫苗处于临床试验阶段登革热疫苗研发仍面临诸多挑战，包括需要对四种血清型诱导均衡免疫反应，以及降低抗体依赖性增强（ADE）的风险相关阅读：综述：抗登革病毒药物研发新进展 | VS推荐 Antiviral agents for dengue virus 深圳三院杨扬/刘映霞/袁静团队：四联生物标志物组合亮相，破解登革热伴中性粒细胞减少症发病密码 | VS推荐 Deep data-independent acquisition-based plasma proteomic profiling unveils distinct molecular features in dengue fever with neutropenia 中山大学团队发现：一个新的促寨卡病毒和登革病毒复制的宿主因子：AP1G1 | VS推荐 Adaptor protein complex 1 gamma 1 subunit is an important host factor involved in both Zika virus and dengue virus infections Eltrombopag 通过抑制 NS2B-NS3 丝氨酸蛋白酶活性发挥抗登革病毒作用 Eltrombopag, an FDA-approved drug, inhibits dengue virus type 2 by targeting NS2B-NS3 protease 双苄基异喹啉生物碱通过影响内体溶酶体转运和自噬来抑制黄病毒的进入和复制| VS推荐 Bis-benzylisoquinoline alkaloids inhibit flavivirus entry and replication by compromising endolysosomal trafficking and autophagy 综述：单细胞转录组测序技术揭示病毒-宿主相互作用 | VS推荐 Single-cell RNA sequencing to understand host-virus interactions Co-circulation of all four DENV serotypes during 2016 outbreak in Sinaloa, Mexico: First report of DENV-4 in patients 期刊简介《中国病毒学（英文）》Virologica Sinica, 是中国科学院武汉病毒研究所和中国微生物学会共同主办的病毒学领域的专业学术期刊。主要刊载病毒学及相关领域的前沿研究及最新进展。本刊最新影响因子 4.0，5年影响因子 4.1, 均位于病毒学领域Q1区(JCR2024), CiteScore 2024 7.9, 位于传染病领域前15%，连续十二年入选“中国最具国际影响力学术期刊”（TOP 5%）。期刊于2022年变更为以金色开放获取模式出版的开源期刊（Open Access Journal），与科爱出版社合作全球出版传播。本刊为中国科技核心期刊，且被SCI、PubMed/Medline、PubMed Central、Scopus等数据库收录。

疫苗

2025-12-27

·药时空

巴西将启动单剂次登革热疫苗接种

“民众非常关心，也很期盼，登革热是困扰了贫民社区几十年的流行病，终于可以‘打一针就解决’。”巴西圣保罗州瓜鲁柳斯特朗奎利达德社区疫苗接种点的健康监察主任瓦莱斯卡·米翁26日告诉记者，其已接到通知，随着产能提升，疫苗接种范围将扩大到全体人群。巴西卫生部日前公布，巴西将于2026年1月底启动单剂次登革热疫苗接种，由巴西布坦坦研究所研制的首批30万剂登革热疫苗已经交付。巴西政府首期投入3.68亿雷亚尔，计划向公共医疗系统提供共390万剂疫苗。预计到2026年1月底，布坦坦研究所还将交付100万剂疫苗。据巴西布坦坦研究所介绍，这款巴西国产疫苗名为Butantan-DV，耗时十余年研制成功，是目前全球唯一获批的单剂次登革热疫苗。作为一款四价登革热疫苗，其可预防所有四种类型的登革热，适用于12至59岁人群。临床研究显示，其对登革热总体病例的保护效力为74.7%，对重症的有效率为91.6%，对因登革热住院治疗的有效率为100%。巴西将在圣保罗州博图卡图市（Botucatu）和塞阿拉州马兰瓜佩市（Maranguape）开展接种试点，首批疫苗将优先提供给基层医疗卫生人员，包括社区卫生员、地方病防控人员及入户服务的医护人员。据了解，为提高产能，该疫苗的生产由巴西布坦坦研究所与中国药明生物公司合作进行。通过巴西卫生部的本地发展与创新计划实施，预计到2026年下半年可供应约3000万剂疫苗。巴西布坦坦研究所官网刊文表示，负责接洽中企的技术经理丹妮拉·文蒂尼评价：“（巴中合作）将显著提高我们的疫苗交付能力，加快民众获得必需产品的步伐。” 去年，巴西登革热病例大幅增加。巴西卫生部虫媒病毒监测工作组公布的数据显示，截至2025年12月26日，巴西2025年共报告登革热疑似病例较去年同期下降75%，仍有1660190例。巴西卫生部表示，疫苗接种将与蚊媒防控、环境治理和公共卫生宣传相结合，持续巩固登革热防控成效。识别微信二维码，可添加药时空小编请注明：姓名+研究方向！

2025-07-13

·ETPharma

Phase-3 clinical trial enrolment for India's first dengue vaccine to be completed by October: ICMR

New Delhi: Enrolment of about 10,500 participants in the phase III clinical trial of the indigenous one-shot Panacea Biotec developed dengue vaccine, DengiAll, is likely to be completed by October across 20 centres in India, according to ICMR scientists. So far, 8,000 participants in various centres at Pune, Chennai, Kolkata, Delhi and Bhubaneswar among others have received either the vaccine or a placebo as part of the trial sponsored by the Indian Council of Medical Research (ICMR) and Panacea Biotec. The trial is co-led by ICMR-National Institute of Translational Virology and AIDS research in Pune, National Institute of Epidemiology (NIE), Chennai and National Institute of Virology, Pune. Currently, there is no antiviral treatment or licensed vaccine against dengue in India. The results of the Phase-1/2 trial has shown no safety concerns for the one-shot vaccine, NIE Director Dr Manoj Murhekar said. "The participants enrolled in the Phase- III trial will be followed up for two-years. This trial will evaluate the efficacy of this tetravalent dengue vaccine," Dr Murhekar said. The multi-centre, double-blind, randomised, placebo-controlled phase-III trial was launched in August last year to evaluate the jab's efficacy, safety and, long-term immunogenicity. The first participant in this trial was vaccinated at the Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS), Rohtak last year. The development of an effective vaccine is complex due to the need to achieve good efficacy for all four serotypes. The dengue virus has four serotypes, 1-4, with low cross-protection against each other, meaning individuals can experience repeated infections, Dr Murhekar said. In India, all four serotypes of dengue virus are known to circulate or co-circulate in many regions. The Union Health Ministry in a statement earlier had said that the tetravalent dengue vaccine strain (TV003/TV005), originally developed by the National Institutes of Health (NIH), USA, has shown promising results in clinical trials in Brazil. Panacea Biotec, one of three Indian companies to receive the strain, is at the most advanced stage of development. The company has worked extensively on these strains to develop a full-fledged vaccine formulation and holds a process patent for this work. Dengue is a major public health concern in India, ranking among the top 30 countries with the highest incidence of the disease. The global incidence of dengue has been steadily increasing over the past two decades, with more than 129 countries reporting dengue viral disease by the end of 2023, according to the World Health Organisation (WHO). In India, approximately 75-80 per cent of infections are asymptomatic, yet these individuals can still transmit the infection through the bite of Aedes mosquitoes. Among the 20-25 per cent of cases where symptoms are clinically apparent, children are at a significantly higher risk of hospitalisation and mortality. In adults, the disease can escalate into severe conditions like dengue hemorrhagic fever and dengue shock syndrome. According to the government data, around 12,043 dengue cases were reported till March this year. In 2024, 2.3 lakh cases and 297 deaths had been recorded.

临床3期疫苗

100 项与 Tetravalent dengue virus vaccine(Instituto Butantan) 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
登革热	申请上市	-	Instituto Butantan	-
寨卡病毒感染	临床1期	美国	National Institute of Allergy & Infectious Diseases	2024-09-24

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05710224 (V181-002, CTgov)	临床2期	登革热	1,364	V181	憲鹹積構網選顧餘選築(顧鏇襯願觸鹹繭餘鏇獵) = 網蓋鏇築製鑰繭簾網範膚襯蓋壓積蓋鏇壓齋遞 (襯憲製窪簾糧糧選積壓, 齋構鹽衊製窪憲襯繭鹹 ~ 選遞製選獵選鑰醖齋願) 更多	-	2025-11-18
NCT02678455 (TV005, CTgov)	临床2期	登革热	192	TV005 vaccine (TV005 Vaccine)	簾襯選醖獵範願簾窪製 = 獵淵夢選醖構範鏇構憲糧遞獵鹹顧網顧齋簾築 (積觸獵鹹鬱構簾壓構蓋, 願艱鹽襯顧膚鏇選鏇鬱 ~ 壓顧鹽鹽網範網製鑰淵) 更多	-	2025-01-17
				Placebo (Placebo)	簾襯選醖獵範願簾窪製 = 鑰遞選壓糧餘淵網衊膚糧遞獵鹹顧網顧齋簾築 (積觸獵鹹鬱構簾壓構蓋, 壓鹽憲網顧夢顧鹽繭願 ~ 觸艱夢膚遞鹽觸艱襯構) 更多
NCT02406729 (DEN-03-IB, Pubmed \| Br Dent J \| N Engl J Med) 人工标引	临床3期	登革热	16,235	Dengue 1,2,3,4 (attenuated) vaccinetan-Dengue Vaccine (Butantan-DV)	衊築糧鹽簾膚憲繭製遞(獵範積願網淵獵淵願繭) = 醖膚衊築廠蓋壓觸製鹹鹹餘鬱齋願獵艱窪簾積 (夢齋鏇淵襯窪鬱齋壓遞, 70.0 ~ 86.3) 更多	积极	2024-02-01
				placebo	夢醖願顧鑰積壓遞鹹繭(築襯簾餘鏇築鑰遞艱繭) = 願蓋鹽積糧憲糧壓製範築淵蓋衊築膚築淵製獵 (獵糧願網遞鹹糧觸衊遞 )
NCT02678455 (Pubmed \| Lancet Infect Dis) 人工标引	临床2期	登革热	192	TV005 vaccine	簾簾糧憲製鏇築膚夢糧(獵糧蓋願衊艱觸積襯築) = 網艱廠範蓋選夢觸廠獵積蓋夢鬱醖鏇選廠醖齋 (窪鑰範蓋壓壓鑰網願顧 ) 更多	积极	2024-02-01
				Placebo	窪構壓範廠艱醖鹽窪範(鏇製鏇鹽選廠壓顧窪艱) = 淵醖製願鹽選淵鬱餘願遞顧鬱襯壓積蓋襯憲製 (築窪襯鏇壓窪蓋蓋構艱, 2.4)
NCT01506570 (Pubmed \| PLoS Negl Trop Dis)	临床1期	黄病毒感染	58	TV003 vaccine	鑰鬱醖衊鹹襯網廠醖鹹(遞鹹觸鑰繭鬱網廠艱製) = few adverse events other than rash, which was predominately mild 鹽獵繭壓壓積壓齋遞鑰 (壓願蓋衊網蓋壓遞鑰淵 )	-	2017-05-01