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      NDV-3 protects mice from vulvovaginal candidiasis through T- and B-cell immune response.

      Vaccine
      Animals, B-Lymphocytes, immunology, Candida albicans, genetics, Candidiasis, Vulvovaginal, prevention & control, Female, Fungal Proteins, Fungal Vaccines, administration & dosage, Immunoglobulin A, analysis, Immunoglobulin G, blood, Injections, Intramuscular, Injections, Subcutaneous, Mice, Mice, Inbred BALB C, Mice, Inbred ICR, Serum, T-Lymphocytes, Vaccines, Synthetic, Vagina

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          Abstract

          We have previously reported that vaccination with rAls3p-N protein of Candida albicans, formulated with alum adjuvant (also designated as NDV-3) protects immunocompetent mice from, lethal disseminated candidiasis and mucosal oropharyngeal candidiasis. NDV-3 vaccine was recently, tested in a Phase 1 clinical trial and found to be safe, well-tolerated, and induced robust humoral and, cellular immune responses with increased interferon (IFN)-gamma and interleukin (IL)-17 secretion. In preparation for a Phase 2 clinical trial against vulvovaginal candidiasis (VVC), we evaluated NDV-3, efficacy in a murine VVC model. Here, NDV-3 induced a strong immune response characterized by high, anti-rAls3p-N serum IgG and vaginal IgA titers. Furthermore, moderate doses of the vaccine (a range of 1-30μg given subcutaneously [SQ] or 0.3-10μg given intramuscularly [IM]) elicited a 10-1000 fold, decrease in vaginal fungal burden vs. control (mice injected with alum adjuvant alone) in both inbred, and outbred mice infected with different clinical C. albicans isolates. Additionally, NDV-3 required both, T and B lymphocytes for efficacy in reducing C. albicans tissue burden, which is followed by a reduction, in neutrophil influx to the affected site. Finally, anti-rAls3p-N antibodies enhanced the ex vivo killing, of C. albicans by neutrophils primed with IFN-gamma. These data indicate that NDV-3 protects mice, from VVC by a mechanism that involves the concerted priming of both humoral and adaptive immune, responses. Copyright © 2013 Elsevier Ltd. All rights reserved.

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