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

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.

01 Jun 2018·Clinical infectious diseases : an official publication of the Infectious Diseases Society of AmericaQ1 · 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: Schwartz, Michael M ; Hennessey, John P ; Lizakowski, Mary ; Nyirjesy, Paul ; Hoover, Keila ; Edwards, Lance ; Edwards, John E ; Augenbraun, Michael ; Schmidt, Clint S ; Hoeg, Jesse ; Filler, Scott G ; Marchus, Erica ; 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.

23 Dec 2014·Proceedings of the National Academy of Sciences of the United States of AmericaQ1 · CROSS-FIELD

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

Q1 · CROSS-FIELD

Article

Author: 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 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
Staphylococcal Infections	Phase 2	US	NovaDigm Therapeutics, Inc.	30 Jan 2018
Candidiasis	Phase 2	US	National Institute of Allergy & Infectious Diseases	24 Nov 2016
Job Syndrome	Phase 2	US	National Institute of Allergy & Infectious Diseases	17 Nov 2016
Candidiasis, Vulvovaginal	Phase 2	US	NovaDigm Therapeutics, Inc.	01 Jul 2013
Yeast infection	Phase 1	US	NovaDigm Therapeutics, Inc.	01 Sep 2011
Staphylococcus Aureus Infections	Phase 1	US	NovaDigm Therapeutics, Inc.	01 Jan 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)	zcixxbraql(wktwhnxbpv) = pehwhwqfpw tvkgiyvqwu (tacaylbanz, gpowhhrjbl - zqsvnktjoc) View more	-	04 Mar 2020
				NDV-3 Vaccine (NDV-3 Vaccine Without Alum)	zcixxbraql(wktwhnxbpv) = jkzgykwuxl tvkgiyvqwu (tacaylbanz, rkthseywmi - msdblbacph) View more
NCT01926028 (CTgov)	Phase 1/2	Candidiasis, Vulvovaginal	188	Placebo (Placebo)	tqqowoszpj(ftpgaionlt) = hpszqpqaen qrsfxmvpag (sheqmkudww, enynnbdwci - hjrtkymeje) View more	-	20 Jun 2018
				NDV-3A (NDV-3A)	tqqowoszpj(ftpgaionlt) = lykmranbvg qrsfxmvpag (sheqmkudww, uomtjdtigw - sqcsodwtnj) View more
NCT01926028 (Pubmed \| Clin Infect Dis) Manual	Phase 2	Candidiasis, Vulvovaginal	178	NDV-3A	vivaratexn(vdqjqndztw) = nflsylstpa gidxfjqppw (qeorlgldqb ) View more	Positive	01 Jun 2018
				Placebo	vivaratexn(vdqjqndztw) = rmpuksvbat gidxfjqppw (qeorlgldqb ) View more