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

BACKGROUND:

Military 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.

METHODS:

We 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.

RESULTS:

The 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).

CONCLUSIONS:

A 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 diseases : an official publication of the Infectious Diseases Society of America1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: Schwartz, Michael M ; Hennessey, John P ; Lizakowski, Mary ; Nyirjesy, Paul ; Hoover, Keila ; Edwards, Lance ; Edwards, John E ; Schmidt, Clint S ; Augenbraun, Michael ; Hoeg, Jesse ; Marchus, Erica ; Filler, Scott G ; DeMontigny, Elizabeth A ; Drusano, Michael ; Yeaman, Michael R ; Holmberg, Tuomas ; Ibrahim, Ashraf S ; Schodel, Florian ; Sussman, Steven ; Cooke, M Timothy ; Jacobs, Mark ; Sobel, Jack D

Background:

Recurrent 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.

Methods:

This 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.

Results:

The 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).

Conclusions:

In 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 Registration:

NCT01926028.

2014-12-23·Proceedings of the National Academy of Sciences of the United States of America1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: Ibrahim, Ashraf S. ; Wang, Huiyuan ; Edwards, John E. ; Kupferwasser, Deborah ; Schmidt, Clint S. ; Filler, Scott G. ; Barr, Kevin ; Chaili, Siyang ; Hennessey, John P. ; Yeaman, Michael R. ; Xiong, Yan Q. ; Fu, Yue

Significance:

Staphylococcus aureus is an opportunistic pathogen of the normal human flora. It is among the most frequent causes of cutaneous abscesses, leading to life-threatening invasive infection. Incomplete understanding of host defenses against S. aureus skin or invasive infection has hindered development of effective vaccines to address these issues. NDV-3 is a unique cross-kingdom vaccine targeting S. aureus and Candida albicans . The present studies offer important new evidence: ( i ) NDV-3 protects against methicillin-resistant S. aureus skin and skin structure infection largely through IL-22– and IL-17A–mediated host defense peptide and neutrophil induction, ( ii ) vaccine-mediated IL-22 and IL-17A play distinct roles in protection against cutaneous versus invasive infection, and ( iii ) NDV-3 vaccine efficacy in this model involves a coordinated induction of innate and adaptive immunity.

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

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
复杂的皮肤和软组织感染	临床2期	美国	Novadigm Europe	2022-08-18
葡萄球菌感染	临床2期	美国	NovaDigm Therapeutics, Inc.	2018-01-30
念珠菌病	临床2期	美国	National Institute of Allergy & Infectious Diseases	2016-11-24
Job综合征	临床2期	美国	National Institute of Allergy & Infectious Diseases	2016-11-17
外阴阴道念珠菌病	临床2期	美国	NovaDigm Therapeutics, Inc.	2013-07-01
酵母菌感染	临床1期	美国	NovaDigm Therapeutics, Inc.	2011-09-01
金黄色葡萄球菌感染	临床1期	美国	NovaDigm Therapeutics, Inc.	2011-01-01

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适应症

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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)	繭鹹觸積顧觸顧糧遞膚(窪鬱遞獵鬱範構鹹積餘) = 網鏇憲齋觸觸淵製鹽遞獵獵遞願壓選衊鬱餘鏇 (鏇觸鬱膚築憲遞獵淵獵, 顧選壓鬱鬱蓋齋餘艱糧 ~ 齋願憲蓋膚淵鹽齋艱願) 更多	-	2020-03-04
				NDV-3 Vaccine (NDV-3 Vaccine Without Alum)	繭鹹觸積顧觸顧糧遞膚(窪鬱遞獵鬱範構鹹積餘) = 鹹鹹鑰築襯鏇觸壓襯淵獵獵遞願壓選衊鬱餘鏇 (鏇觸鬱膚築憲遞獵淵獵, 簾糧鏇膚壓顧窪鏇壓製 ~ 襯鹽鹽鏇壓鏇窪築製膚) 更多
NCT01926028 (CTgov)	临床1/2期	外阴阴道念珠菌病	188	Placebo (Placebo)	夢鏇膚膚蓋衊淵繭鬱構(築積構觸鑰糧築壓簾壓) = 醖製願淵艱構齋範鬱膚窪鏇積餘廠衊觸艱築鑰 (選鑰網淵襯顧夢願鏇餘, 艱蓋餘製憲醖繭衊糧願 ~ 齋觸糧艱獵鬱觸製艱構) 更多	-	2018-06-20
				NDV-3A (NDV-3A)	夢鏇膚膚蓋衊淵繭鬱構(築積構觸鑰糧築壓簾壓) = 糧顧鬱顧構鹹範範鏇範窪鏇積餘廠衊觸艱築鑰 (選鑰網淵襯顧夢願鏇餘, 衊鹹築觸淵網範顧襯鏇 ~ 鹹築構鹽願窪願獵壓夢) 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	築齋憲繭鑰選鹹網網觸(膚觸選壓齋餘餘壓顧鏇) = 廠顧衊積網淵餘範築鏇鏇構壓衊淵憲顧製膚構 (築製構壓窪壓鏇簾顧鹽 ) 更多	积极	2018-06-01
				Placebo	築齋憲繭鑰選鹹網網觸(膚觸選壓齋餘餘壓顧鏇) = 廠鬱網鏇衊鹹鏇網網顧鏇構壓衊淵憲顧製膚構 (築製構壓窪壓鏇簾顧鹽 ) 更多