Delving into the Latest Updates on Recombinant protein vaccine (NDV-3) against S.aureus and Candida(Los Angeles Biomedical Research Institute at Harbor-UCLA/NovaDigm Therapeutics, Inc.) with Synapse

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.

Start Date17 Nov 2016

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

NCT01926028

/ CompletedPhase 1/2

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.

Start Date01 Jul 2013

Sponsor / Collaborator

NovaDigm Therapeutics, Inc.

100 Clinical Results associated with Recombinant protein vaccine (NDV-3) against S.aureus and Candida(Los Angeles Biomedical Research Institute at Harbor-UCLA/NovaDigm Therapeutics, Inc.)

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100 Translational Medicine associated with Recombinant protein vaccine (NDV-3) against S.aureus and Candida(Los Angeles Biomedical Research Institute at Harbor-UCLA/NovaDigm Therapeutics, Inc.)

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100 Patents (Medical) associated with Recombinant protein vaccine (NDV-3) against S.aureus and Candida(Los Angeles Biomedical Research Institute at Harbor-UCLA/NovaDigm Therapeutics, Inc.)

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10

Literatures (Medical) associated with Recombinant protein vaccine (NDV-3) against S.aureus and Candida(Los Angeles Biomedical Research Institute at Harbor-UCLA/NovaDigm Therapeutics, Inc.)

01 May 2021·VaccineQ3 · MEDICINE

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

Q3 · MEDICINE

Article

Author: Tribble, David R ; Millar, Eugene V ; Cochrane, Terrence ; Timothy Cooke, M ; Carey, Patrick M ; Barin, Burc ; Schwartz, Michael 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.

01 Jun 2018·Clinical Infectious DiseasesQ1 · MEDICINE

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

Q1 · MEDICINE

Article

Author: 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.

23 Dec 2014·Proceedings of the National Academy of SciencesQ1 · CROSS-FIELD

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

Q1 · CROSS-FIELD

Article

Author: Wang, Huiyuan ; Chaili, Siyang ; Yeaman, Michael R. ; 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 Deals associated with Recombinant protein vaccine (NDV-3) against S.aureus and Candida(Los Angeles Biomedical Research Institute at Harbor-UCLA/NovaDigm Therapeutics, Inc.)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Complicated skin and soft tissue infection	Phase 2	US	Novadigm Europe	18 Aug 2022
Candidiasis	Phase 2	-	Novadigm Europe	-
Candidiasis	Phase 2	-	The Lundquist Institute	-
Staphylococcal Infections	Phase 2	-	The Lundquist Institute	-
Staphylococcal Infections	Phase 2	-	Novadigm Europe	-
Job Syndrome	Preclinical	US	National Institute of Allergy & Infectious Diseases	17 Nov 2016
Staphylococcus Aureus Infections	Discovery	US	NovaDigm Therapeutics, Inc.	30 Jan 2018
Candidiasis, Vulvovaginal	Discovery	US	NovaDigm Therapeutics, Inc.	01 Jul 2013
Yeast infection	Discovery	US	NovaDigm Therapeutics, Inc.	01 Sep 2011

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Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01447407 (CTgov)	Phase 1	Candidiasis \| Yeast infection \| Staphylococcal Infections	164	NDV-3 Vaccine (NDV-3 Vaccine With Alum)	lvtlsbabwf(fojzxjgkgn) = qrvvrfxdxd cysgebhetu (oohdhohvtz, ztnuqmhbya - xguljwloin) View more	-	04 Mar 2020
				NDV-3 Vaccine (NDV-3 Vaccine Without Alum)	lvtlsbabwf(fojzxjgkgn) = asiazmgeho cysgebhetu (oohdhohvtz, ldoinuwesb - bkxidamunu) View more
NCT01926028 (CTgov)	Phase 1/2	Candidiasis, Vulvovaginal	188	Placebo (Placebo)	ewxikdetek(otljbxgkih) = cdxslippdf nlnlcrxbvu (fqfkwfcvdv, gdhdajhylr - cugtgpzzdt) View more	-	20 Jun 2018
				NDV-3A (NDV-3A)	ewxikdetek(otljbxgkih) = sqhssvsyzj nlnlcrxbvu (fqfkwfcvdv, ocubultkgq - yzgxvanlsv) View more
NCT01926028 (Pubmed \| Clin Infect Dis) Manual	Phase 2	Candidiasis, Vulvovaginal	178	NDV-3A	pwnwwbsucj(olldtdkhlt) = hygnhebovt iryhugiaxh (facvaeouea ) View more	Positive	01 Jun 2018
				Placebo	pwnwwbsucj(olldtdkhlt) = oqmdbglfwd iryhugiaxh (facvaeouea ) View more