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NCT01926028 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, Immunogenicity and Efficacy of NDV-3A Vaccine in Preventing Recurrent Vulvovaginal Candidiasis
A Phase 1 study, sponsored by NovaDigm Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 188
- Enrollment target
NCT01926028: Completed Phase 1 study, sponsored by NovaDigm Therapeutics.
NCT01926028 is a Phase 1 study that has completed, run by NovaDigm Therapeutics. The registered enrollment target is 188 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (213% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01926028, a Phase 1 study, has completed, sponsored by NovaDigm Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 188 participants
- Enrollment target
Study 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.
Primary Outcome
Summary of injection site reactions for the safety population over the 12-months post-vaccination period in the NDV-3A vaccine group, the NDV-3 vaccine group, and the placebo group.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL NDV-3A
- BIOLOGICAL NDV-3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 188 participants |
| Start Date | 2013-07 |
| Est. Completion | 2016-05 |
| Phase | Phase 1 |
What the finished NCT01926028 record still lists
NCT01926028 is an interventional study that assigns participants to a tested intervention. The registered 188 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (213% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01926028 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01926028 about?
NCT01926028 is a clinical study titled "Safety, Tolerability, Immunogenicity and Efficacy of NDV-3A Vaccine in Preventing Recurrent Vulvovaginal Candidiasis". 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 ...
What is the current status of trial NCT01926028?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 188 participants. The study started on 2013-07. Estimated completion is 2016-05.
What interventions are being tested in trial NCT01926028?
The interventions under investigation include: Placebo (BIOLOGICAL), NDV-3A (BIOLOGICAL), NDV-3 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01926028?
This trial is sponsored by NovaDigm Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01926028's enrollment target sits among peer trials
188 289th of 2000 higher than 1,711 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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