Recombinant protein vaccine (NDV-3) against S.aureus and Candida(Los Angeles Biomedical Research Institute at Harbor-UCLA/NovaDigm Therapeutics, Inc.)(Recombinant protein vaccine (NDV-3) against S.aureus and Candida(Los Angeles Biomedical Research Institute at Harbor-UCLA/NovaDigm Therapeutics, Inc.)) - 药物靶点：Protective antigen_在研适应症：复杂的皮肤和软组织感染，念珠菌病，葡萄球菌感染_专利_临床

项与 Recombinant protein vaccine (NDV-3) against S.aureus and Candida(Los Angeles Biomedical Research Institute at Harbor-UCLA/NovaDigm Therapeutics, Inc.) 相关的临床试验

NCT03455309

/ Completed临床2期

A Phase 2 Double-blind Placebo-controlled Study to Evaluate the Safety, Immunogenicity and Efficacy of NDV-3A Vaccine in Preventing S. Aureus Colonization

The proposed study aims to further evaluate the safety and immunogenicity of a candidate S. aureus vaccine NDV-3A, as well as its efficacy against acquisition of S. aureus

开始日期2018-01-30

申办/合作机构

NovaDigm Therapeutics, Inc.

[+1]

NCT02996448

/ Terminated临床2期IIT

A Phase 2a Study to Evaluate the Safety, Tolerability, and Immunogenicity of One Dose of NDV-3A Vaccine in Patients With STAT3-Mutated Hyper-IgE Syndrome

Background:
AD-HIES is a disease that weakens the immune system. It puts people at risk for infections, particularly Staph and Candida infections. Researchers want to test a vaccine that may help keep people from getting these infections, which would help people with AD-HIES.
Objective:
To test the new vaccine NDV-3A for protection against infection from the yeast Candida and the bacterium Staphylococcus aureus (Staph).
Eligibility:
Adults ages 18-55 who have AD-HIES
Healthy volunteers ages 18-55
Design:
Participants will have 6-7 study visits over 6-7 months. They will also be contacted by phone in between some visits.
Participants will be screened with a medical history, physical exam, and blood and urine tests.
Participants will have 2 baseline visits. They will have repeat the screening tests. They will have samples of saliva, stool, skin, mucus (oral, nasal, and/or vaginal) collected. Vaginal and stool samples are optional. Any eczema on their skin will be looked at.
Participants will fill out symptom diary cards to record how they feel.
Participants will have the NDV-3A vaccine injected into a muscle in the arm.
Participants will return the next 2 days. They will have a physical exam. Blood will be collected.
Participants will have 2 more follow-up visits at the NIH. They will have a physical exam. They will have blood, saliva, stool, skin, vaginal fluid, and/or mucus samples collected. Vaginal and stool samples are optional.
Participants will be called once a month for 5 months after the vaccination. There is an optional visit about 6 weeks after the vaccination. Participants will provide a blood sample at this visit.

开始日期2016-11-17

申办/合作机构

National Institute of Allergy & Infectious Diseases

NCT01926028

/ Completed临床1/2期

Phase 1b/2a, Multi-center, Double-blind, Randomized, Placebo-controlled Study of a Single Dose of NDV-3A or NDV-3 Vaccine to Evaluate Safety, Tolerability, Immunogenicity and Efficacy in Preventing Recurrent Vulvovaginal Candidiasis

This is a multi-center, randomized, double-blind, placebo-controlled study intended to assess the safety, tolerability and humoral and cellular immune response over a 12-month period after receiving one dose of either the NDV-3A vaccine, NDV-3 vaccine, or placebo. In addition, the clinical efficacy of NDV-3A vaccine in lowering the recurrence rate of vulvovaginal candidiasis (VVC) in patients with recurrent VVC (RVVC) will be evaluated relative to placebo.

开始日期2013-07-01

申办/合作机构

NovaDigm Therapeutics, Inc.

100 项与 Recombinant protein vaccine (NDV-3) against S.aureus and Candida(Los Angeles Biomedical Research Institute at Harbor-UCLA/NovaDigm Therapeutics, Inc.) 相关的临床结果

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100 项与 Recombinant protein vaccine (NDV-3) against S.aureus and Candida(Los Angeles Biomedical Research Institute at Harbor-UCLA/NovaDigm Therapeutics, Inc.) 相关的转化医学

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100 项与 Recombinant protein vaccine (NDV-3) against S.aureus and Candida(Los Angeles Biomedical Research Institute at Harbor-UCLA/NovaDigm Therapeutics, Inc.) 相关的专利（医药）

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10

项与 Recombinant protein vaccine (NDV-3) against S.aureus and Candida(Los Angeles Biomedical Research Institute at Harbor-UCLA/NovaDigm Therapeutics, Inc.) 相关的文献（医药）

2021-05-01·Vaccine3区 · 医学

Safety, immunogenicity, and efficacy of NDV-3A against Staphylococcus aureus colonization: A phase 2 vaccine trial among US Army Infantry trainees

3区 · 医学

Article

作者: Tribble, David R ; Millar, Eugene V ; Cochrane, Terrence ; Timothy Cooke, M ; Barin, Burc ; Schwartz, Michael M ; Carey, Patrick M ; English, Caroline E ; Law, Natasha N ; Hennessey, John P ; Ellis, Michael W ; Bennett, Jason W

BACKGROUNDMilitary trainees are at increased risk for Staphylococcus aureus colonization and infection. Disease prevention strategies are needed, but a S. aureus vaccine does not currently exist.METHODSWe enrolled US Army Infantry trainees (Fort Benning, GA) in a phase 2, randomized, double-blind, placebo-controlled trial of NDV-3A, a vaccine containing a recombinant adhesin/invasion protein of Candida albicans that has structural similarity to the S. aureus protein clumping factor A. Study participants received one intramuscular dose of NDV-3A or placebo (adjuvant alone) within 72 h of arrival on base. Longitudinal nasal and oral (throat) swabs were collected throughout the 14-week Infantry training cycle. Safety, immunogenicity, and efficacy of NDV-3A against S. aureus nasal / oral acquisition were the endpoints.RESULTSThe NDV-3A candidate had minimal reactogenicity and elicited robust antigen-specific B- and T-cell responses. During the 56-day post-vaccination period, there was no difference in the incidence of S. aureus nasal acquisition between those who were randomized to receive NDV-3A vs. placebo (25.6% vs. 29.1%; vaccine efficacy [VE]: 12.1%; p = 0.31). In time-to-event analysis, there was no difference between study groups with respect to the S. aureus colonization-free interval (VE: 13%; p = 0.29). Similarly, the efficacy of NDV-3A against S. aureus oral acquisition was poor (VE: 2.4%; p = 0.52).CONCLUSIONSA single dose of NDV-3A did not prevent nasal nor oral acquisition of S. aureus in a population of military trainees at high risk for colonization.

2018-06-01·Clinical Infectious Diseases1区 · 医学

A Fungal Immunotherapeutic Vaccine (NDV-3A) for Treatment of Recurrent Vulvovaginal Candidiasis—A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial

1区 · 医学

Article

作者: Sobel, Jack D ; Filler, Scott G ; Sussman, Steven ; Drusano, Michael ; Yeaman, Michael R ; Augenbraun, Michael ; Cooke, M Timothy ; Schodel, Florian ; Edwards, Lance ; Marchus, Erica ; Edwards, John E ; Jacobs, Mark ; Hoeg, Jesse ; Nyirjesy, Paul ; Holmberg, Tuomas ; Ibrahim, Ashraf S ; Hennessey, John P ; Lizakowski, Mary ; DeMontigny, Elizabeth A ; Schmidt, Clint S ; Hoover, Keila ; Schwartz, Michael M

BackgroundRecurrent vulvovaginal candidiasis (RVVC) is a problematic form of mucosal Candida infection, characterized by repeated episodes per year. Candida albicans is the most common cause of RVVC. Currently, there are no immunotherapeutic treatments for RVVC.MethodsThis exploratory randomized, double-blind, placebo-controlled trial evaluated an immunotherapeutic vaccine (NDV-3A) containing a recombinant C. albicans adhesin/invasin protein for prevention of RVVC.ResultsThe study in 188 women with RVVC (n = 178 evaluable) showed that 1 intramuscular dose of NDV-3A was safe and generated rapid and robust B- and T-cell immune responses. Post hoc exploratory analyses revealed a statistically significant increase in the percentage of symptom-free patients at 12 months after vaccination (42% vaccinated vs 22% placebo; P = .03) and a doubling in median time to first symptomatic episode (210 days vaccinated vs 105 days placebo) for the subset of patients aged <40 years (n = 137). The analysis of evaluable patients, which combined patients aged <40 years (77%) and ≥40 years (23%), trended toward a positive impact of NDV-3A versus placebo (P = .099).ConclusionsIn this unprecedented study of the effectiveness of a fungal vaccine in humans, NDV-3A administered to women with RVVC was safe and highly immunogenic and reduced the frequency of symptomatic episodes of vulvovaginal candidiasis for up to 12 months in women aged <40 years. These results support further development of NDV-3A vaccine and provide guidance for meaningful clinical endpoints for immunotherapeutic management of RVVC.Clinical Trials RegistrationNCT01926028.

2014-12-23·Proceedings of the National Academy of Sciences1区 · 综合性期刊

Mechanisms of NDV-3 vaccine efficacy in MRSA skin versus invasive infection

1区 · 综合性期刊

Article

作者: Wang, Huiyuan ; Yeaman, Michael R. ; Chaili, Siyang ; Filler, Scott G. ; Xiong, Yan Q. ; Hennessey, John P. ; Ibrahim, Ashraf S. ; Barr, Kevin ; Schmidt, Clint S. ; Fu, Yue ; Edwards, John E. ; Kupferwasser, Deborah

Increasing rates of life-threatening infections and decreasing susceptibility to antibiotics urge development of an effective vaccine targeting Staphylococcus aureus. This study evaluated the efficacy and immunologic mechanisms of a vaccine containing a recombinant glycoprotein antigen (NDV-3) in mouse skin and skin structure infection (SSSI) due to methicillin-resistant S. aureus (MRSA). Compared with adjuvant alone, NDV-3 reduced abscess progression, severity, and MRSA density in skin, as well as hematogenous dissemination to kidney. NDV-3 induced increases in CD3+ T-cell and neutrophil infiltration and IL-17A, IL-22, and host defense peptide expression in local settings of SSSI abscesses. Vaccine induction of IL-22 was necessary for protective mitigation of cutaneous infection. By comparison, protection against hematogenous dissemination required the induction of IL-17A and IL-22 by NDV-3. These findings demonstrate that NDV-3 protective efficacy against MRSA in SSSI involves a robust and complementary response integrating innate and adaptive immune mechanisms. These results support further evaluation of the NDV-3 vaccine to address disease due to S. aureus in humans.

100 项与 Recombinant protein vaccine (NDV-3) against S.aureus and Candida(Los Angeles Biomedical Research Institute at Harbor-UCLA/NovaDigm Therapeutics, Inc.) 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
复杂的皮肤和软组织感染	临床2期	美国	Novadigm Europe	2022-08-18
念珠菌病	临床2期	-	Novadigm Europe	-
念珠菌病	临床2期	-	The Lundquist Institute	-
葡萄球菌感染	临床2期	-	Novadigm Europe	-
葡萄球菌感染	临床2期	-	The Lundquist Institute	-
Job综合征	临床前	美国	National Institute of Allergy & Infectious Diseases	2016-11-17
金黄色葡萄球菌感染	药物发现	美国	NovaDigm Therapeutics, Inc.	2018-01-30
外阴阴道念珠菌病	药物发现	美国	NovaDigm Therapeutics, Inc.	2013-07-01
酵母菌感染	药物发现	美国	NovaDigm Therapeutics, Inc.	2011-09-01

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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


NCT01447407 (CTgov)	临床1期	念珠菌病 \| 酵母菌感染 \| 葡萄球菌感染	164	NDV-3 Vaccine (NDV-3 Vaccine With Alum)	齋餘鹽廠網廠鬱醖獵膚(鬱醖鹹簾壓夢醖壓夢築) = 淵遞廠積構鏇繭顧艱醖廠齋餘網積膚鬱窪鬱製 (糧獵範齋壓廠築積築艱, 製鹽鹹壓築鑰艱繭築獵 ~ 壓鬱鹹鬱淵鏇積淵鹽觸) 更多	-	2020-03-04
				NDV-3 Vaccine (NDV-3 Vaccine Without Alum)	齋餘鹽廠網廠鬱醖獵膚(鬱醖鹹簾壓夢醖壓夢築) = 蓋糧淵齋醖餘鬱觸範網廠齋餘網積膚鬱窪鬱製 (糧獵範齋壓廠築積築艱, 壓憲膚鹹廠鏇膚襯顧顧 ~ 遞壓廠蓋觸醖獵廠築鑰) 更多
NCT01926028 (CTgov)	临床1/2期	外阴阴道念珠菌病	188	Placebo (Placebo)	製鬱築築獵鏇築構壓醖(築壓鹽選蓋積網夢顧衊) = 觸構蓋鑰鹹築鏇蓋鹹遞構鏇遞淵願簾齋窪築鹹 (糧遞齋襯蓋鏇願繭構齋, 襯簾簾膚簾襯醖鏇襯選 ~ 夢糧鬱餘鏇遞製膚構鹽) 更多	-	2018-06-20
				NDV-3A (NDV-3A)	製鬱築築獵鏇築構壓醖(築壓鹽選蓋積網夢顧衊) = 鏇襯鏇齋襯餘顧憲襯衊構鏇遞淵願簾齋窪築鹹 (糧遞齋襯蓋鏇願繭構齋, 淵壓獵蓋觸廠淵蓋獵獵 ~ 窪醖積顧積膚鹹壓鬱醖) 更多
NCT01926028 (Pubmed \| Clin Infect Dis) 人工标引	临床2期	外阴阴道念珠菌病	178	NDV-3A	艱糧觸繭淵壓襯網窪網(膚鬱網醖艱築鏇夢鑰鏇) = 簾蓋醖獵遞顧憲範繭鹽衊網顧鹽糧夢構鏇鑰廠 (餘鏇蓋襯艱繭鏇鏇鹽艱 ) 更多	积极	2018-06-01
				Placebo	艱糧觸繭淵壓襯網窪網(膚鬱網醖艱築鏇夢鑰鏇) = 餘襯憲製鏇觸選範壓夢衊網顧鹽糧夢構鏇鑰廠 (餘鏇蓋襯艱繭鏇鏇鹽艱 ) 更多