학술논문
A Fungal Immunotherapeutic Vaccine (NDV-3A) for Treatment of Recurrent Vulvovaginal Candidiasis-A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial.
Document Type
article
Author
Edwards, John; Schwartz, Michael; Schmidt, Clint; Sobel, Jack; Nyirjesy, Paul; Schodel, Florian; Marchus, Erica; Lizakowski, Mary; DeMontigny, Elizabeth; Hoeg, Jesse; Holmberg, Tuomas; Cooke, M; Hoover, Keila; Edwards, Lance; Jacobs, Mark; Sussman, Steven; Augenbraun, Michael; Drusano, Michael; Hennessey, John; Yeaman, Michael; Filler, Scott; Ibrahim, Ashraf
Source
Clinical Infectious Diseases. 66(12)
Subject
Language
Abstract
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