CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 164 enrolled
Drug / intervention
NDV-3 vaccine with alum IM +3 morebiological
Likely dose
Not stated in 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/NCT01447407
NCT01447407Phase 1Completed
CompareCT.gov

Phase 1b Study to Evaluate the Safety and Immunogenicity of NDV-3 Formulated With or Without Alum (AlOH) and Administered Either Intramuscular (IM) or Intradermally (ID) to Healthy Adults

NovaDigm Therapeutics, Inc.·interventional·Posted Oct 6, 2011·Updated Mar 4, 2020

In Brief

A Phase 1 clinical trial evaluating NDV-3 vaccine with alum IM, NDV-3 vaccine without alum IM, and 2 other interventions for Staphylococcal Infections and 2 related conditions. Completed, enrolled 164 participants across 1 site.

Detailed Summary

This partially-blind, placebo controlled study is a Phase 1b study using an investigational vaccine, NDV-3, directed against Staphylococcus aureus and Candida sp. This study will compare NDV-3 administered with or without alum delivered intramuscularly (IM) at one dose level. It will also evaluate a lower dose of NDV-3 without alum delivered intradermally (ID) compared to placebo delivered ID.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStaphylococcal Infections, Yeast Infections, Candidiasis
CountriesUnited States
CollaboratorsUnited States Department of Defense

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 6, 2011
Enrollment StartSep 1, 2011
Primary CompletionMar 1, 2012
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 14.7 years ago

Interventions

NDV-3 vaccine with alum IMbiological

One dose administered IM

NDV-3 vaccine without alum IMbiological

One dose administered IM

Placebo with alum IMbiological

One dose administered ID

NDV-3 vaccine without alum IDbiological

One dose administered ID