CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 188 enrolled
Drug / intervention
NDV-3A +2 morebiological
Likely dose
NDV-3A 0.5mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01926028
NCT01926028Phase 2Completed
CompareCT.gov

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

NovaDigm Therapeutics, Inc.·interventional·Posted Aug 20, 2013·Updated Jul 18, 2018

In Brief

A Phase 2 clinical trial evaluating NDV-3A, NDV-3, and 1 other intervention for Vulvovaginal Candidiasis. Completed, enrolled 188 participants across 20 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVulvovaginal Candidiasis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 20, 2013
Enrollment StartJul 1, 2013
Primary CompletionMay 1, 2015
Study CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 12.9 years ago

Interventions

NDV-3Abiological

0.5mL injection IM

NDV-3biological

0.5mL injection IM

Placebobiological

aluminum hydroxide and buffered saline