Clinical Trial: Safety, Tolerability, Immunogenicity and Efficacy of NDV-3A Vaccine in Preventing Recurrent Vulvovaginal Candidiasis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Re

Brief Summary: 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.

Detailed Summary:

The purpose of the Phase 1b portion of this study is to compare the NDV-3A vaccine, the NDV-3 vaccine and the placebo head-to-head in the patient population of interest (women with RVVC) to evaluate safety and immunogenicity. The study size for comparing safety and immunogenicity (N=15 per group) is based on the dose comparison design used in study NDV3-001 (clinical trials.gov Identifier NCT01273922).

The primary purpose of the Phase 2a portion of this study is to further evaluate safety, tolerability, and immunogenicity of the NDV-3A vaccine compared to placebo in a patient population of interest (women with RVVC). The secondary purpose is to determine whether the NDV-3A vaccine decreases the recurrence rate of VVC in 18-50 year old women with RVVC when compared to placebo. The study size for evaluating efficacy (N=87 per group) is based on assuming a 50% rate of VVC recurrences over the 6 month post-vaccination period in the placebo group and a 50% vaccine efficacy.


Sponsor: NovaDigm Therapeutics, Inc.

Current Primary Outcome: Safety and tolerability over the 12-months post vaccination period [ Time Frame: 12-month ]

Number of vaccine-related adverse events over the 12-months post-vaccination period in the NDV-3A vaccine group, the NDV-3 vaccine group, and the placebo group.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Recurrence of VVC over the 6-month post-vaccination period [ Time Frame: 6 months ]
    Recurrence of VVC due to Candida albicans in women with documented RVVC over the 6-month post-vaccination period in the NDV-3A vaccine group and the placebo group
  • Humoral immune response over the 12-month post-vaccination period [ Time Frame: 12-months ]
    Serum anti-Als3 antibody titers will be measured by ELISA at pre-defined time points over the 12-month post-vaccination period in the NDV-3A vaccine group, the NDV-3 vaccine group, and the placebo group.
  • Cellular immune response over the 12-month post-vaccination period [ Time Frame: 12-months ]
    Als3-specific T-cell responses will be measured by enzyme-linked immunospot (ELISpot) at pre-defined time points over the 12-month post-vaccination period in the NDV-3A vaccine group, the NDV-3 vaccine group, and the placebo group.


Original Secondary Outcome: Same as current

Information By: NovaDigm Therapeutics, Inc.

Dates:
Date Received: August 9, 2013
Date Started: July 2013
Date Completion:
Last Updated: September 21, 2016
Last Verified: September 2016