Clinical Trials Logo
  1. Home
  2. Vulvovaginal Candidiasis
  3. NCT01926028

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

Vulvovaginal Candidiasis Clinical Trial

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 Recurrent Vulvovaginal Candidiasis

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01926028
Study type Interventional
Source NovaDigm Therapeutics, Inc.
Contact
Status Completed
Phase Phase 1/Phase 2
Start date July 2013
Completion date May 2016
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05012852 - Evaluation of VagiVitalAC for Treatment of Candida Vulvovaginitis N/A
Completed NCT02150655 - Study of the Microbiota, Metabolome, and Environmental Toxins in Relation to Reproductive Health in Rwandan Women Phase 0
Completed NCT00755053 - Comparative Efficacy of Ovule vs Tablet Phase 3
Completed NCT02679456 - Safety and Efficacy of Oral Ibrexafungerp (SCY-078) vs. Oral Fluconazole in Subjects With Vulvovaginal Candidiasis Phase 2
Completed NCT02242695 - Comparative Efficacy Study of 10 mg Dequalinium Chloride (Fluomizin) in the Treatment of Vulvovaginal Candidiasis Phase 4
Recruiting NCT06397248 - DeVEnIR: Defining Vulvovaginal Candidiasis - Elements of Infection and Remedy
Completed NCT00895453 - Monthly Itraconazole Versus Classic Homeopathy for Treatment of Recurrent Vulvovaginal Candidiasis (RVVC) N/A
Completed NCT05327192 - VVC Sampling Study for Analysis Validation
Completed NCT05399641 - Ibrexafungerp for the Treatment of Complicated Vulvovaginal Candidiasis Phase 3
Completed NCT01806623 - The Study Of Fluconazole For Vulvovaginal Candidiasis Phase 3
Recruiting NCT05079711 - Comparative Performance of a Vaginal Yeast Test
Completed NCT05507333 - Clinical Performance of the Gedea Pessary in Adult Women With Vulvovaginal Candidiasis N/A
Completed NCT01144286 - Arasertaconazole Nitrate Pessaries - Dose Finding Study for the Vulvovaginal Candidiasis (VVC) Treatment Phase 2
Completed NCT00353561 - Diabetes Mellitus and Vulvovaginal Candidiasis Phase 3
Recruiting NCT05895162 - Zinc-containing Vaginal Gel and Oral Fluconazole for Vulvovaginal Candidiasis. N/A
Not yet recruiting NCT06450990 - Efficacy, Safety, and Dose-response of a Live Biotherapeutic Product in Women With Acute Vaginal Infection Phase 1/Phase 2
Recruiting NCT05908682 - Safety of Pregnant Subjects Exposed to Ibrexafungerp Including Infant Outcomes
Completed NCT02203942 - Comparing NAAT Testing to Standard Methods for the Diagnosis of Vaginitis N/A
Completed NCT00194324 - Effect of Exercise on Spread of the Miconozole Nitrate OVULE in the Vagina Phase 4
Completed NCT02866227 - TOL-463 Phase 2 Study for Vaginitis Phase 2