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Safety and Immunogenicity Study of a Recombinant Protein Vaccine (NDV-3) Against S.Aureus and Candida

NCT01273922 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2012-05-22

No results posted yet for this study

Summary

This randomized, double-blind, placebo-controlled study is a first-in-human Phase 1 study using two dose levels of an investigational vaccine directed against S. aureus and Candida. The study is designed to evaluate the safety, tolerability and immunogenicity of the investigational vaccine, NDV-3

Conditions

  • Staphylococcal Infections
  • Candidiasis

Interventions

BIOLOGICAL

NDV-3 investigational vaccine

Two doses of vaccine 6 months apart or placebo(only one dose at Time 0) administered intramuscularly

Sponsors & Collaborators

  • Cetero Research, San Antonio

    collaborator NETWORK

  • 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
2011-01-31
Primary Completion
2011-10-31
Completion
2011-12-31

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 NCT01273922 on ClinicalTrials.gov