A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Single Dose, Dose-ranging Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccine Administered Orally to Healthy Volunteers Aged Greater Than or Equal to 18 Years and Less Than or Equal to 80 Years Old.

This study is designed to evaluate the safety and immunogenicity of two monovalent Norovirus (NoV) oral tableted vaccine candidates, VXA-G1.1-NN and VXA-GII.4-NS co-administered (bivalent delivery) against a matching placebo arm. Bivalent GI.1 and GII.4 vaccines are being investigated for the prevention of noroviral gastroenteritis caused by norovirus GI.1 and GII.4.

开始日期2023-01-26

申办/合作机构

Vaxart, Inc.

NCT05212168

/ Completed临床1/2期

A Phase 2b Double-Blinded, Randomized, Placebo-Controlled, Human Norovirus GI.1 (Norwalk Virus Inoculum) Challenge Study Following Administration of an Oral, Single-dose Norovirus Vaccine Expressing GI.1 VP1 and dsRNA Adjuvant to Protect Against Norovirus Gastroenteritis (NVG) in Healthy Adult Volunteers

This is a Phase 2b randomized, double-blind, placebo-controlled vaccination and challenge study to assess the protective efficacy of the Vaxart Norovirus vaccine (VXA-G1.1-NN). Healthy adults will be randomized in a 1:1 ratio to receive one oral dose of vaccine or placebo.
Arm 1: VXA-G1.1-NN oral vaccine tablets [1x1011 IU±0.5 log]
Arm 2: Placebo tablets similar in appearance and number to active vaccine tablets
Approximately 28 days post-vaccination, subjects will be admitted to an isolation ward and challenged with the NV GI.1 Norwalk challenge strain. After challenge, subjects will be monitored for signs and symptoms of acute gastroenteritis (AGE) from Day 29 to discharge. At 4 days post challenge (Day 33) asymptomatic subjects will be discharged from the isolation ward and will be followed in a series of outpatient visits and telephone calls. Symptomatic subjects may be kept in the isolation ward for up to an additional 3 days.

开始日期2022-01-28

申办/合作机构

Vaxart, Inc.

NCT05213728

/ Completed临床1期

A Phase 1, Open-label, Safety and Immunogenicity Study of an Oral Multi-dose Administration Regimen With an Adenoviral-vector Based Tablet Norovirus Vaccine (VXA-G1.1-NN) Expressing GI.1 VP1 Administered to Healthy Adult Volunteers

Subjects will receive multiple sub-doses over a 4-hour period to deliver a total overall dose of 1E11. Evaluations of immunogenicity, safety, and tolerability will be evaluated. The active period consists of data collection at Day 1, Day 8, and Day 29. Safety follow-up continues by phone screen at Day 180 and Day 365.

开始日期2022-01-24

申办/合作机构

Vaxart, Inc.

100 项与 Monovalent norovirus Vaccine(Vaxart) 相关的临床结果

登录后查看更多信息

100 项与 Monovalent norovirus Vaccine(Vaxart) 相关的转化医学

登录后查看更多信息

100 项与 Monovalent norovirus Vaccine(Vaxart) 相关的专利（医药）

登录后查看更多信息

项与 Monovalent norovirus Vaccine(Vaxart) 相关的文献（医药）

2025-03-05·Science Translational Medicine

An oral norovirus vaccine tablet was safe and elicited mucosal immunity in older adults in a phase 1b clinical trial

Article

作者: Tedjakusuma, Sarah N. ; Gutierrez, Samanta ; Tucker, Sean N. ; Cuevas-Juárez, Esmeralda ; Pasetti, Marcela F. ; Cummings, James F. ; Neuhaus, Elena D. ; Shriver, Mallory ; Braun, Molly R. ; Flitter, Becca A. ; Lester, Colin A. ; Greco, Susan N.

Norovirus is a leading cause of acute gastroenteritis globally, with infections in older adults associated with heightened severity and increased risk of mortality. Currently, no licensed vaccines are available to prevent norovirus infection. We developed an orally administered vaccine tablet (VXA-G1.1-NN) that delivers a nonreplicating adenoviral vector expressing norovirus GI.1 major capsid protein VP1 to the small intestine. Here, we report safety and immunogenicity results of a randomized, double-blind, placebo-controlled clinical trial (NCT04854746) that investigated the oral administration of VXA-G1.1-NN in two groups of healthy older adults aged 55 to 65 and 66 to 80 years. VXA-G1.1-NN was administered orally at three dose levels by prime and boost, 28 days apart. Immunization was well tolerated regardless of dose, with mild to moderate reported solicited symptoms and no related serious or grade 3 adverse events. Oral delivery of VXA-G1.1-NN elicited VP1-specific serum immunoglobulin G (IgG) and IgA and functional antibodies in a dose-dependent manner 28 days postvaccination and remained above baseline for 210 days. Moreover, robust circulating VP1-specific IgA antibody-secreting cells were detected 1 week postvaccination along with IgA + plasmablasts expressing the mucosal-homing marker α4β7. VP1-specific IgA increased in saliva and nasal lining fluid 28 days postvaccination in both age groups and remained above baseline concentrations through 210 days, demonstrating durable mucosal responses. This clinical trial established that oral administration of VXA-G1.1-NN is safe, well tolerated, and induces robust systemic and mucosal immune responses in adults up to 80 years old.

项与 Monovalent norovirus Vaccine(Vaxart) 相关的新闻（医药）

2025-03-09

·药明康德

快速持久降解目标蛋白超80%的小分子疗法；有望使患者停止激素替代治疗的创新生物器官疗法…… | 一周盘点

▎药明康德内容团队编辑本期看点 1. 小分子蛋白降解剂BHV-1300的1期临床试验结果积极，目标IgG快速、深度和持续地降低，降幅最高达84%，中位降幅为80%。 2. 创新生物混合器官Cell Pouch获批一项新的IND申请，它与自体甲状腺细胞疗法相结合，旨在恢复自然的甲状腺功能，使患者无需使用甲状腺激素替代药物或免疫抑制疗法。 3. 巨噬细胞疗法Allocetra治疗中度至重度膝骨关节炎，在一项1/2期临床试验中使患者报告的疼痛平均减少47.0%，关节功能改善46%。药明康德内容团队整理 BHV-1300：公布1期临床试验的新数据 Biohaven公司公布了其皮下给药的在研小分子蛋白降解剂BHV-1300的1期临床试验的新结果。BHV-1300在选择性清除目标IgG（IgG1、IgG2和IgG4）方面具有独特优势，同时保留IgG3水平。IgG3在对抗细菌、寄生虫和病毒中发挥关键作用。BHV-1300的设计目标是避免与其他IgG降低方法相关的广泛免疫抑制，同时在治疗自身免疫性疾病的过程中允许免疫系统对潜在感染做出反应。在为期四周的1期研究中，每周皮下注射1000 mg剂量的BHV-1300可使总IgG快速、深度和持续地降低，降幅最高达84%，中位降幅为80%。在每次给药后的数小时内，患者的IgG就会逐渐降低，并且与基线值相比，在四周内持续降低。BHV-1300在高达2000 mg的皮下给药剂量下安全性和耐受性良好。大多数不良事件轻微，可自行消退，没有因与研究药物相关的不良事件而停药，也没有严重的不良事件。 ▲BHV-1300的作用方式和1期临床试验结果（图片来源：参考资料[7]） Cell Pouch：IND申请获得FDA许可 Sernova Biotherapeutics公司宣布，美国FDA已批准其IND申请，允许在因结节性甲状腺疾病接受甲状腺手术的患者中评估Cell Pouch与自体移植甲状腺细胞的联合疗法。Sernova公司的Cell Pouch是一种创新的生物混合器官，由非生物材料与活体组织结合而成，旨在恢复或增强受损器官的功能。Cell Pouch与自体甲状腺细胞疗法相结合，旨在通过提供一种稳定、长期的生理解决方案，恢复自然甲状腺功能，而无需使用甲状腺激素替代药物或免疫抑制疗法。临床前研究表明，在没有免疫抑制的情况下，将甲状腺组织重新植入预先血管化的Cell Pouch中，成功地将两种主要的甲状腺激素——甲状腺素（T4）和三碘甲状腺原氨酸（T3）恢复到甲状腺切除术前水平，而无需激素补充。放射性同位素成像和组织学分析证实，植入后5个月内Cell Pouch内存在健康、功能性的甲状腺组织。 Allocetra：公布1/2期临床试验的中期数据 Enlivex Therapeutics公司公布了其巨噬细胞疗法Allocetra治疗中度至重度膝骨关节炎的1/2期临床试验的中期数据。败血症、骨关节炎、银屑病关节炎等疾病会使巨噬细胞失去平衡状态。这些非稳态巨噬细胞在很大程度上导致了相应疾病的严重性。Allocetra是一种通用、现货型细胞疗法，通过对巨噬细胞进行重编程，旨在恢复其稳态（homeostasis），进而治疗疾病。Allocetra提供创新的免疫调节机制，具潜力作为单药或组合疗法治疗这些具未竟医疗需求的疾病。此次公布的结果显示，治疗后第6个月，患者报告的疼痛平均显著减少了47.0%（P=0.0001），关节功能改善了46%。此外，83%接受治疗的患者在6个月时仍被认为对治疗有应答。这表明Allocetra作为骨关节炎的潜在突破性治疗方法，具有良好的持久性和持续疗效。安全性方面，没有报告严重的不良事件。 PER-001：公布1/2a期临床试验数据 Perfuse Therapeutics公司公布了其玻璃体内植入疗法PER-001在青光眼患者中的首次人体1/2a期试验的24周数据。PER-001是一种新型的小分子长效内皮素受体拮抗剂。内皮素是人体内最强的血管收缩剂，在青光眼中上调，并通过其在视网膜血管和神经视网膜细胞中的受体参与炎症和细胞死亡。PER-001是一种生物可降解的植入疗法，通过一次性25号注射器注入眼球玻璃体腔中。该疗法被设计为每6个月给药一次，能够持续释放药物。 24周的数据表明，PER-001具有良好的耐受性，仅有一例药物相关不良事件（轻微且短暂的玻璃体飞蚊症），没有严重药物相关不良事件或眼内炎症报告。接受PER-001治疗的患者从第1周开始，视神经头血流量较基线平均增加了至少10%，并持续至第24周。第24周时，光学相干断层扫描（OCT）显示，PER-001治疗组患者的视野平均偏差改善了1 dB/年，视网膜神经纤维层厚度平均增加了3微米。相比之下，假手术对照组患者的视野平均偏差下降了0.63 dB/年，OCT视网膜神经纤维层厚度减少了1.3微米。这些结果表明，PER-001在青光眼患者中不仅安全性良好，还显示出显著的功能和结构改善，为其作为青光眼治疗的潜在疗法提供了概念验证。 RPESC-RPE-4W：公布1/2a期临床试验数据 Luxa Biotechnology公司公布了一项1/2a期临床试验的数据，该试验评估了其专有的视网膜色素上皮（RPE）细胞疗法RPESC-RPE-4W在干性年龄相关性黄斑变性（AMD）患者中的应用。RPESC-RPE-4W是一种基于成人RPE干细胞的疗法，旨在通过替换受损的RPE细胞来恢复视力功能。干性AMD是一种导致中心视力模糊或丧失的退行性眼病，目前尚无有效治疗方法。在1/2a期试验的最低剂量组中，6名干性AMD患者被分为视力较差组和视力较好组。视力较差组的3名患者在12个月的随访中，平均在ETDRS视力表上获得了21.67个字母的改善，视力较好组的3名患者在3个月时，平均改善了3.3个字母。 VXA-G1.1-NN：公布1b期临床试验数据 Vaxart公司宣布，其第一代口服诺如病毒候选疫苗VXA-G1.1-NN在老年人群（55-80岁）中的1b期临床试验完整数据已发表在学术期刊Science Translational Medicine上。VXA-G1.1-NN是一种口服疫苗片剂，将表达诺如病毒GI.1主要衣壳蛋白VP1的非复制性腺病毒载体递送到小肠，旨在预防由诺如病毒引起的急性胃肠炎。该试验评估了VXA-G1.1-NN在55-65岁和66-80岁两个健康老年人群中的安全性和免疫原性。受试者以2：1的比例随机接受疫苗或安慰剂，并在第28天进行加强接种。63名志愿者完成了研究，安全性及免疫原性评估持续至第390天。免疫原性结果显示，与安慰剂相比，疫苗在所有三个剂量组中均诱导了强效且持久的血清抗体反应，第29天和第57天的血清抗VP1 IgA水平显著增加，且抗VP1 IgG水平也显著高于接种前水平，呈剂量依赖性增加。口服疫苗还刺激了唾液和鼻腔中强烈且持久的IgA反应。安全性方面，疫苗在老年人群中表现出良好的安全性和耐受性，未发生与疫苗相关的3级不良事件。最常见的不良反应为头痛（14%）和不适/疲劳（16%），与安慰剂组的发生率相似。 APG990：公布1期临床试验的中期数据 Apogee Therapeutics公司公布了其新型半衰期延长的OX40L单克隆抗体APG990的首个人体试验的积极中期结果。APG990是一种皮下注射疗法，靶向炎症通路中位于IL-13上游的OX40L，从而对1型、2型和3型炎症通路产生广泛影响。此次公布的结果显示，APG990的半衰期约为60天，可支持每3个月或6个月一次的维持给药方案。在所有5个剂量组（最高剂量为1200 mg）中，APG990均表现出良好的耐受性。Apogee公司还开发了APG279，即APG777（一种深度抑制2型炎症的药物）与APG990的联合制剂，旨在实现单次注射2 mL联合制剂，每年仅需给药2-4次的治疗方案，为患者提供更有效的治疗选择，同时最大限度地减少其他可用疗法的副作用。 BL-001：公布1期临床试验数据 Bloom Science公司公布了其在研口服疗法BL-001在一项涉及32名健康成年人（体重从正常到超重）的1期试验中的疗效和安全性结果。BL-001是一种潜在“first-in-class”、口服给药的活生物治疗产品（LBP），旨在模拟生酮饮食的治疗效果。临床前数据表明，BL-001在癫痫模型中复制了生酮饮食的治疗效果，并进一步展示了其对γ-氨基丁酸（GABA）和其他关键生物能途径的调节作用，以抑制癫痫发作的关键驱动因素——过度兴奋性。 BL-001在28天的治疗期内在体重减轻方面的整体治疗效果具有统计学显著性（p=0.0424）。超重组（BMI≥25）中接受BL-001治疗的受试者与所有接受安慰剂的受试者相比，体重的百分比变化具有统计学意义（p=0.0007）。此外，BL-001治疗的超重和正常体重个体之间的体重百分比变化也具有统计学意义（p=0.0003），体重减轻最高为4.9%。80%在BL-001治疗期间体重减轻的受试者在最后一次给药两周后仍保持体重减轻，其中接受最高剂量的所有超重受试者的体重继续下降，在两周随访期结束时体重减少了3.4%。此外，BL-001治疗组观察到了剂量依赖性的变化，包括尿酮、食欲降低和体重减轻，而安慰剂组未观察到这些变化。靶向生物标志物分析显示，与食欲控制、代谢调节和消化相关的关键代谢激素发生了具有统计学意义的变化。更大规模的代谢组学分析还揭示了循环酮体的统计学显著变化，这些发现进一步支持了BL-001的潜在生酮和减肥效果。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料（可上下滑动查看） [1] Perfuse Therapeutics Announces Positive Visual, Structural and Safety Data from a Ph1/2a Trial of PER-001 in Glaucoma Patients at the American Glaucoma Society Meeting. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/perfuse-therapeutics-announces-positive-visual-structural-and-safety-data-from-a-ph12a-trial-of-per-001-in-glaucoma-patients-at-the-american-glaucoma-society-meeting-302387598.html [2] Sernova Biotherapeutics Receives FDA Clearance for IND Application for its Cell Pouch Bio-hybrid Organ with Autograft Thyroid Cells in Patients with Hypothyroidism. Retrieved March 7, 2025, from https://www.globenewswire.com/news-release/2025/03/03/3035709/0/en/Sernova-Biotherapeutics-Receives-FDA-Clearance-for-IND-Application-for-its-Cell-Pouch-Bio-hybrid-Organ-with-Autograft-Thyroid-Cells-in-Patients-with-Hypothyroidism.html [3] Enlivex Therapeutics Announces Investor Webinar to Discuss Positive Interim Data from Phase I/II Allocetra™ Trial in Knee Osteoarthritis. Retrieved March 7, 2025, from https://www.globenewswire.com/news-release/2025/03/04/3036995/0/en/Enlivex-Therapeutics-Announces-Investor-Webinar-to-Discuss-Positive-Interim-Data-from-Phase-I-II-Allocetra-Trial-in-Knee-Osteoarthritis.html [4] Bloom Science Reports Positive Data from Phase 1 Trial of BL-001 Demonstrating Statistically Significant, Durable Weight Loss in Overweight Individuals. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/bloom-science-reports-positive-data-from-phase-1-trial-of-bl-001-demonstrating-statistically-significant-durable-weight-loss-in-overweight-individuals-302391446.html [5] Bioheng Therapeutics Announces FDA Clearance of IND Application for CD7 UCAR T Cell Therapy in T-ALL/LBL. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/bioheng-therapeutics-announces-fda-clearance-of-ind-application-for-cd7-ucar-t-cell-therapy-in-t-alllbl-302392846.html [6] Neurocrine Biosciences Announces Initiation of Phase 1 Clinical Study Evaluating NBI-1140675, a Second-Generation VMAT2 Inhibitor, in Healthy Adults. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/neurocrine-biosciences-announces-initiation-of-phase-1-clinical-study-evaluating-nbi-1140675-a-second-generation-vmat2-inhibitor-in-healthy-adults-302392294.html [7] Biohaven Reports Positive Degrader Data Achieving > 80% Sustained Reductions in Total IgG with Potential First-in-Class BHV-1300. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/biohaven-reports-positive-degrader-data-achieving--80-sustained-reductions-in-total-igg-with-potential-first-in-class-bhv-1300-302389515.html [8] Adiso Therapeutics Announces Data Publication of Two Phase 1 Studies of First-in-Class Neutrophil Modulator ADS051 in the American Journal of Gastroenterology. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/adiso-therapeutics-announces-data-publication-of-two-phase-1-studies-of-first-in-class-neutrophil-modulator-ads051-in-the-american-journal-of-gastroenterology-302393958.html [9] Apogee Therapeutics Announces Positive Interim Phase 1 Results from the APG990 Healthy Volunteer Trial, Unlocking Potential Maintenance Dosing Every Three and Six Months for APG279 (APG777 + APG990). Retrieved March 7, 2025, from https://www.globenewswire.com/news-release/2025/03/03/3035377/0/en/Apogee-Therapeutics-Announces-Positive-Interim-Phase-1-Results-from-the-APG990-Healthy-Volunteer-Trial-Unlocking-Potential-Maintenance-Dosing-Every-Three-and-Six-Months-for-APG279-.html [10] Acadia Pharmaceuticals and Saniona Announce Initial Positive Results from ACP-711 (formerly SAN711) Phase 1 Study. Retrieved March 7, 2025, from https://acadia.com/en-us/media/news-releases/acadia-pharmaceuticals-and-saniona-announce-initial-positive [11] Actio Biosciences Announces First Participant Dosed in Phase 1 Clinical Trial of ABS-0871, a Novel TRPV4 Inhibitor, for the Treatment of Charcot Marie Tooth Disease 2C. Retrieved March 7, 2025, from https://actiobiosciences.com/actio-biosciences-announces-first-participant-dosed-in-phase-1-clinical-trial-of-abs-0871-a-novel-trpv4-inhibitor-for-the-treatment-of-charcot-marie-tooth-disease-2c/ [12] Contineum Therapeutics Initiates Patient Dosing in Phase 1b Positron Emission Tomography (PET) Trial of PIPE-791. Retrieved March 7, 2025, from https://www.businesswire.com/news/home/20241216396391/en/Contineum-Therapeutics-Initiates-Patient-Dosing-in-Phase-1b-Positron-Emission-Tomography-PET-Trial-of-PIPE-791 [13] Phio Pharmaceuticals Announces Completion of Enrollment in Third Safety Cohort in PH-762 Phase 1b Dose-Escalation Study. Retrieved March 7, 2025, from https://phiopharma.com/phio-pharmaceuticals-announces-completion-of-enrollment-in-third-safety-cohort-in-ph-762-phase-1b-dose-escalation-study/ [14] Bambusa Therapeutics Announces First Subject Dosed in Phase 1 Clinical Trial of BBT001, a Novel Multi-Targeting, Half-Life Extended Bispecific Antibody for the Treatment of Atopic Dermatitis and Other Inflammatory Skin Diseases. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/bambusa-therapeutics-announces-first-subject-dosed-in-phase-1-clinical-trial-of-bbt001-a-novel-multi-targeting-half-life-extended-bispecific-antibody-for-the-treatment-of-atopic-dermatitis-and-other-inflammatory-skin-diseases-302388661.html [15] Luxa Biotechnology Presents Clinical Data from First-in-Human Retinal Pigment Epithelium Cell Therapy Trial for Dry Age-Related Macular Degeneration at the 77th Annual Wills Eye Conference. Retrieved March 7, 2025, from https://www.businesswire.com/news/home/20250306998366/en/Luxa-Biotechnology-Presents-Clinical-Data-from-First-in-Human-Retinal-Pigment-Epithelium-Cell-Therapy-Trial-for-Dry-Age-Related-Macular-Degeneration-at-the-77th-Annual-Wills-Eye-Conference [16] ImmunoGenesis Doses First Patient in Phase 1/2 Clinical Trial of IMGS-101 in Combination With Balstilimab (anti-PD-1) and Zalifrelimab (anti-CTLA-4) in Relapsed or Refractory Advanced Prostate, Pancreatic, and HPV(-) Head & Neck Tumors. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/immunogenesis-doses-first-patient-in-phase-12-clinical-trial-of-imgs-101-in-combination-with-balstilimab-anti-pd-1-and-zalifrelimab-anti-ctla-4-in-relapsed-or-refractory-advanced-prostate-pancreatic-and-hpv--head--neck-t-302393719.html [17] Vaxart Announces Publication Demonstrating the Immunogenicity and Safety of its First-Generation Oral Pill Norovirus Vaccine Candidate in Elderly Adults. Retrieved March 7, 2025, from https://investors.vaxart.com/news-releases/news-release-details/vaxart-announces-publication-demonstrating-immunogenicity-and 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床申请临床1期细胞疗法免疫疗法临床结果

2024-10-15

·GlobeNewswire-Health Care

Vaxart to Present Norovirus Data at IDWeek 2024 Underscoring Commitment to Address Significant Unmet Need

SOUTH SAN FRANCISCO, Calif., Oct. 15, 2024 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced that it will present research demonstrating the potential of its norovirus oral pill vaccine candidate at IDWeek taking place October 16-19, 2024, at the Los Angeles Convention Center in Los Angeles. With no currently approved vaccines against norovirus, Vaxart remains committed to progressing what it believes to be the most advanced norovirus vaccine candidate in clinical development that is both formulated for oral administration and designed for delivery to the gastrointestinal system. Norovirus sickens approximately 21 million people in the United States each year, including the 15% of children under age 5 who contract norovirus annually. Approximately 3 million sets of parents are forced by this virus to miss work – approximately 2.2 days on average – to care for their children. Adults ≥65 years old are at high-risk for severe symptoms and clinical outcomes including longer disease duration and death. The annual disease burden from norovirus in the United States is estimated to be $10.6 billion Presentation Information: Title: A Phase 2 Double-Blind, Placebo-Controlled Study Showing Oral Tableted Norovirus Vaccine VXA-G1.1-NN is Immunogenic, Efficacious, and Reduces Viral Shedding Following Norovirus ChallengeSpeaker: Dr. Sean Tucker, Founder and Chief Scientific Officer of VaxartDate: Thursday, October 17Time: 3:45 p.m. PTRoom: 404 AB Title: A Phase I, Multicenter, Randomized, Double-blind, Placebo-controlled Single Dose, Dose-ranging Study to Evaluate the Safety, Tolerability, and Immunogenicity of Orally Administered Bivalent GI.1/GII.4 Norovirus Vaccine in Healthy Lactating Females ≥ 18 years Old and Their Breast-feeding InfantsSpeaker: Dr. Lam Nguyen, Medical Director & Head of Pharmacovigilance of VaxartDate: Saturday, October 19, 2024Time: 2:15 p.m. PTRoom: 403 B About VaxartVaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are designed to be administered using pills that can be stored and shipped without refrigeration and to eliminate the risk of needle-stick injury. Vaxart believes that its proprietary pill vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Vaxart’s development programs currently include pill vaccines designed to protect against coronavirus, norovirus and influenza, as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart’s first immune-oncology indication. Vaxart has filed broad domestic and international patent applications covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists. Contact Vaxart Media and Investor RelationsMatt SteinbergFINN PartnersIR@vaxart.com(646) 871-8481 This press release was published by a CLEAR® Verified individual.

疫苗临床2期临床1期

2023-09-07

·FierceBiotech

Vaxart norovirus vaccine fails to stop symptoms in midphase test but hits on other endpoints

Vaxart’s stock rose 1.7% to 81 cents in premarket trading. Vaxart is still looking a little queasy. The biotech delivered mixed data on its oral monovalent norovirus vaccine candidate, with the failure to cut acute gastroenteritis in the challenge study ensuring a muted response from investors despite successes on other endpoints. For the midphase challenge study, investigators randomized people to receive VXA-G1.1-NN, an adenoviral-vector based norovirus vaccine, or placebo. One month after vaccination, the subjects entered an isolation ward and were exposed to the norovirus strain targeted by the vaccine. One primary endpoint looked at the rate of acute gastroenteritis by monitoring subjects for symptoms such as diarrhea, vomiting and nausea in the week after they were exposed to the virus. VXA-G1.1-NN failed to perform significantly better than placebo on a composite endpoint of norovirus gastroenteritis, with 44.7% of participants suffering symptoms in the treatment group compared to 56.9% in the control. Talking on a conference call with investors to discuss the results, James Cummings, M.D., chief medical officer at Vaxart, predicted that the vaccine may perform better outside of the artificial challenge environment. “We use lots of copies of virus to ensure a high infection rate. In nature, 10 to 15 copies of virus is generally enough to give certain susceptible individuals disease. Field efficacy generally goes up, because the amount of inoculum that is causing disease that will be seen in the field is far lower than what is seen in the challenge study,” Cummings said. “My projection is that we would see an improvement in the decrease of [acute gastroenteritis] with our vaccine.” The potential for the vaccine to perform better in field studies was one cause for optimism identified by Vaxart. Infection data were another positive. In the 76 recipients of VXA-G1.1-NN, Vaxart saw a norovirus infection rate of 47.9%. The infection rate was lower than the 81.5% figure seen in the control group, resulting in a statistically significantly 29% relative risk reduction. Vaxart sees the finding as evidence that its vaccine can reduce viral transmission. “The 29% rate of infection certainly decreases the chance of transmitting virus to others, and I would fold into that the decrease in viral shedding as well,” Cummings said. “That may also decrease transmission in those close contact environments. That's, to me, the two-pronged benefit of those findings.” The company is continuing to analyze the data to inform a larger phase 2b trial and identify ways to cut the size and duration of a planned registration trial. Vaxart is also working on a bivalent vaccine that may provide broader protection. Investors were largely unmoved by the update, sending the biotech’s stock up 1.7% to 81 cents in premarket trading.

疫苗临床2期临床结果

100 项与 Monovalent norovirus Vaccine(Vaxart) 相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
诺如病毒感染	临床2期	美国	Vaxart, Inc.	2023-01-26
胃肠炎	临床前	美国	Vaxart, Inc.	2016-07-29

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05626803 (CTgov)	临床2期	诺如病毒感染	135	VXA-GII.4-NS+VXA-G1.1-NN (Bivalent GI.1/GII.4 Vaccine Medium Dose)	築遞膚鹽製網鹹壓鑰齋(遞蓋壓襯鬱淵夢蓋選繭) = 鏇願遞窪鬱鹽網鏇繭鏇膚鏇鹹獵衊淵構獵膚廠 (壓膚衊網獵蓋窪網簾窪, 網願艱壓積簾顧壓願餘 ~ 築齋選鹽膚選蓋鏇願範) 更多	-	2025-04-15
				Bivalent GI.1/GII.4 Vaccine (Bivalent GI.1/GII.4 Vaccine High Dose)	築遞膚鹽製網鹹壓鑰齋(遞蓋壓襯鬱淵夢蓋選繭) = 鑰鹹顧觸鑰膚鑰衊範齋膚鏇鹹獵衊淵構獵膚廠 (壓膚衊網獵蓋窪網簾窪, 構製獵鏇獵鏇艱廠襯繭 ~ 憲鏇製蓋鹹齋壓糧範願) 更多
NCT04875676 (VXA-NVV-105, CTgov)	临床1/2期	诺如病毒感染	30	VXA-G1.1-NN (Cohort 1 (4-week Boost Vaccination))	選鑰襯襯願獵鏇襯糧鏇(窪憲蓋夢齋積鬱襯壓膚) = 膚窪艱淵鬱獵廠獵繭網膚選繭範餘壓襯齋獵製 (衊鑰鏇壓繭夢廠襯願窪, 繭遞窪醖艱簾構觸鹹網 ~ 鹹構醖膚積網獵餘觸憲) 更多	-	2024-05-22
				VXA-G1.1-NN (Cohort 2 (8-week Boost Vaccination))	選鑰襯襯願獵鏇襯糧鏇(窪憲蓋夢齋積鬱襯壓膚) = 製窪範艱衊積糧壓蓋淵膚選繭範餘壓襯齋獵製 (衊鑰鏇壓繭夢廠襯願窪, 鏇選積觸夢夢壓網範顧 ~ 選襯鬱艱膚鑰鑰憲構觸) 更多