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ACE527 Safety and Immunogenicity Study

NCT00901654 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2010-01-29

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and immune response to ACE527.

Conditions

  • Enterotoxigenic E. Coli (ETEC) Infection

Interventions

BIOLOGICAL

ACE527 vaccine

First cohort: Two doses, each of 3x10\^9 cfu of each strain (9x10\^9 cfu total per dose) administered on Days 0 and Day 21 (out-patient). Second cohort: Two doses, each of 3x10\^10 cfu of each strain (9x10\^10 cfu total per dose) administered on Days 0 and Day 21

BIOLOGICAL

Placebo vaccine

First and second cohort: The placebo vaccine will be administered at Days 0 and Days 21.

Sponsors & Collaborators

  • Pierrel Research USA, Inc.

    collaborator INDUSTRY

  • Johns Hopkins University

    collaborator OTHER

  • TD Vaccines A/S

    lead INDUSTRY

Principal Investigators

  • Clayton Harro, MD · Johns Hopkins Bloomberg School of Public Health

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
2009-06-30
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT00901654 on ClinicalTrials.gov