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Completed Phase 1Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT01926028

Public ClinicalTrials.gov record NCT01926028. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 12:21 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT01926028
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
NovaDigm Therapeutics, Inc.
Industry
Enrollment
188 participants

Conditions and interventions

Interventions

Biological

Eligibility (public fields only)

Age range
18 Years to 50 Years
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 2013 (Type not available)
Primary completion
May 2015 (Actual)
Completion
May 2016 (Actual)
Last update posted
Jul 18, 2018

2013 – 2016

United States locations

U.S. sites
20
U.S. states
11
U.S. cities
20
Facility City State ZIP Site status
Precision Trials LLC Phoenix Arizona 85032 —
Arkansas Women's Center Little Rock Arkansas 72205 —
Women's Health Care Research Corp San Diego California 92123 —
McCann MD Research, Inc. Torrance California 90505 —
Women's Medical Research Group, LLC Clearwater Florida 33759 —
KO Clinical Research, LLC Fort Lauderdale Florida 33316 —
Miami Clinical Research, LLC Miami Florida 33155 —
Community Medical Research Miami Beach Florida 33141 —
Community Medical Research LLC North Miami Florida 33181 —
MedPharmics Metairie Louisiana 70006 —
WSU Physician's Group Detroit Michigan 48201 —
Saginaw Valley Medical Research Group, LLC Saginaw Michigan 48604 —
Lawrence OB/Gyn Clinical Research Lawrenceville New Jersey 08648 —
SUNY Downstate Medical Center Brooklyn New York 11203 —
Suffolk Ob/Gyn Port Jefferson New York 11777 —
Drexel University College of Medicine Philadelphia Pennsylvania 19102 —
Magnolia OB/GYN Research Center, LLC Myrtle Beach South Carolina 29752 —
Advanced Research Associates Corpus Christi Texas 78414 —
Discovery Clinical Trials- HCWC, LLC Dallas Texas 75231 —
TMC Life Research Houston Texas 77054 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01926028, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 18, 2018 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01926028 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →