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ACE393-103 Vaccination Challenge Study

NCT00859716 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2009-03-11

No results posted yet for this study

Summary

The purpose of this study is to determine whether ACE393 vaccination can protect against Campylobacteriosis in a challenge model.

Conditions

  • Campylobacter Infection

Interventions

BIOLOGICAL

ACE393

ACE393 250 micrograms as intra muscular injection at day 0 and day 21

BIOLOGICAL

Placebo vaccine

Placebo 500 micrograms Alhydrogel as intra muscular injection at day 0 and day 21

Sponsors & Collaborators

  • SNBL Clinical Pharmacology Center, Inc.

    collaborator INDUSTRY

  • Johns Hopkins University

    collaborator OTHER

  • University of Vermont

    collaborator OTHER

  • SGS U.S. Testing Company Inc.

    collaborator INDUSTRY

  • Fulcrum Pharma (Europe) Ltd

    collaborator UNKNOWN

  • TD Vaccines A/S

    lead INDUSTRY

Principal Investigators

  • Mohamed Al-Ibrahim, MD · Shin Nippon Biomedical Laboratories

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
2008-10-31
Primary Completion
2009-03-31
Completion
2009-07-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT00859716 on ClinicalTrials.gov