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

Start Date30 Jan 2018

Sponsor / Collaborator

NovaDigm Therapeutics, Inc.

[+1]

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.

NCT01447407 / CompletedPhase 1

Phase 1b Study to Evaluate the Safety and Immunogenicity of NDV-3 Formulated With or Without Alum (AlOH) and Administered Either Intramuscular (IM) or Intradermally (ID) to Healthy Adults

This partially-blind, placebo controlled study is a Phase 1b study using an investigational vaccine, NDV-3, directed against Staphylococcus aureus and Candida sp. This study will compare NDV-3 administered with or without alum delivered intramuscularly (IM) at one dose level. It will also evaluate a lower dose of NDV-3 without alum delivered intradermally (ID) compared to placebo delivered ID.

Start Date01 Sep 2011

Sponsor / Collaborator

NovaDigm Therapeutics, Inc.

[+1]

100 Clinical Results associated with NovaDigm Therapeutics, Inc.

0 Patents (Medical) associated with NovaDigm Therapeutics, Inc.

Literatures (Medical) associated with NovaDigm Therapeutics, Inc.

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.

06 Jan 2017·Annual Review of Pharmacology and ToxicologyQ1 · MEDICINE

Innovative Approaches to Improve Anti-Infective Vaccine Efficacy

Q1 · MEDICINE

Review

Author: Yeaman, Michael R. ; Hennessey, John P.

Safe and efficacious vaccines are arguably the most successful medical interventions of all time. Yet the ongoing discovery of new pathogens, along with emergence of antibiotic-resistant pathogens and a burgeoning population at risk of such infections, imposes unprecedented public health challenges. To meet these challenges, innovative strategies to discover and develop new or improved anti-infective vaccines are necessary. These approaches must intersect the most meaningful insights into protective immunity and advanced technologies with capabilities to deliver immunogens for optimal immune protection. This goal is considered through several recent advances in host-pathogen relationships, conceptual strides in vaccinology, and emerging technologies. Given a clear and growing risk of pandemic disease should the threat of infection go unmet, developing vaccines that optimize protective immunity against high-priority and antibiotic-resistant pathogens represents an urgent and unifying imperative.

01 Nov 2015·Infection and ImmunityQ2 · MEDICINE

Nonredundant Roles of Interleukin-17A (IL-17A) and IL-22 in Murine Host Defense against Cutaneous and Hematogenous Infection Due to Methicillin-Resistant Staphylococcus aureus

Q2 · MEDICINE

Article

Author: Edwards, John E. ; Wang, Huiyuan ; Miller, Lloyd S. ; Yeaman, Michael R. ; Barr, Kevin ; Kupferwasser, Deborah ; Ibrahim, Ashraf S. ; Filler, Scott G. ; Chaili, Siyang ; Schmidt, Clint S. ; Chan, Liana C. ; Xiong, Yan Q. ; Hennessey, John P.

ABSTRACTStaphylococcus aureus is the leading cause of skin and skin structure infections (SSSI) in humans. Moreover, the high frequency of recurring SSSI due to S. aureus , particularly methicillin-resistant S. aureus (MRSA) strains, suggests that infection induces suboptimal anamnestic defenses. The present study addresses the hypothesis that interleukin-17A (IL-17A) and IL-22 play distinct roles in immunity to cutaneous and invasive MRSA infection in a mouse model of SSSI. Mice were treated with specific neutralizing antibodies against IL-17A and/or IL-22 and infected with MRSA, after which the severity of infection and host immune response were determined. Neutralization of either IL-17A or IL-22 reduced T cell and neutrophil infiltration and host defense peptide elaboration in lesions. These events corresponded with increased abscess severity, MRSA viability, and CFU density in skin. Interestingly, combined inhibition of IL-17A and IL-22 did not worsen abscesses but did increase gamma interferon (IFN-γ) expression at these sites. The inhibition of IL-22 led to a reduction in IL-17A expression, but not vice versa. These results suggest that the expression of IL-17A is at least partially dependent on IL-22 in this model. Inhibition of IL-17A but not IL-22 led to hematogenous dissemination to kidneys, which correlated with decreased T cell infiltration in renal tissue. Collectively, these findings indicate that IL-17A and IL-22 have complementary but nonredundant roles in host defense against cutaneous versus hematogenous infection. These insights may support targeted immune enhancement or other novel approaches to address the challenge of MRSA infection.

100 Deals associated with NovaDigm Therapeutics, Inc.

100 Translational Medicine associated with NovaDigm Therapeutics, Inc.

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Drug(Targets)	Indications	Global Highest Phase

NDV-4	Candidiasis More	Discontinued
Recombinant protein vaccine (NDV-3) against S.aureus and Candida(Los Angeles Biomedical Research Institute at Harbor-UCLA/NovaDigm Therapeutics, Inc.) ( Protective antigen )	Yeast infection More	Pending
Candida vaccine Sap2(Istituto Superiore di Sanità)	Candidiasis, Vulvovaginal More	Pending

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