MedTrace Logo

Dose Escalation Trial of a Plague Vaccine, Flagellin/F1/V, in Healthy Adult Volunteers

NCT01381744 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2016-01-29

No results posted yet for this study

Summary

Plague is an infectious disease of animals and humans caused by bacteria, Yersinia pestis. Modern antibiotics are effective against plague, but if an infected person is not treated promptly the disease is likely to cause illness or death. The purpose of this study is to evaluate at the safety, immunogenicity (bodily defense reaction), and tolerability of a new research vaccine. Up to 48 people will be enrolled in this study at the Center for Vaccine Development at Saint Louis University. Four groups of 12 volunteers will be given vaccine or placebo (inactive substance) one group at a time starting with the lowest dose working up to the highest dose. Shots will be given in the arm 2 times separated by 28 days. Study procedures include: physical exam, blood samples, and recording temperature and side effects in a memory aid. Participants will be involved in study related procedures for about 13 months.

Conditions

  • Plague

Interventions

BIOLOGICAL

Flagellin/F1/V

Flagellin/F1/V recombinant fusion protein vaccine administered by the intramuscular route on Days 0 and 28 at a dose of 1, 3, 6, or 10 micrograms (mcg). It is a clear, colorless solution.

OTHER

Placebo

Phosphate buffered saline (PBS) used as diluent and placebo.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT01381744 on ClinicalTrials.gov