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Effect of Adjuvant & Route of Administration on Safety & Immunogenicity of NDV-3 Vaccine

NCT01447407 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2020-03-04

Study results available
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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.

Conditions

  • Staphylococcal Infections
  • Yeast Infections
  • Candidiasis

Interventions

BIOLOGICAL

NDV-3 vaccine with alum IM

One dose administered IM

BIOLOGICAL

NDV-3 vaccine without alum IM

One dose administered IM

BIOLOGICAL

Placebo with alum IM

One dose administered ID

BIOLOGICAL

NDV-3 vaccine without alum ID

One dose administered ID

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • NovaDigm Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-03-31
Completion
2012-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01447407 on ClinicalTrials.gov