MedTrace Logo

Phase II Tularemia Vaccine Comparison

NCT01150695 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2016-01-13

No results posted yet for this study

Summary

The purpose of this study is to compare 2 experimental vaccines that could provide protection from the disease, tularemia. This research will compare the ability of the vaccines to cause the body to develop an immune (protective) response and obtain more information on side effects of the vaccines. About 220 male and non-pregnant female volunteers 18 to 45 years will participate. Volunteers will be assigned to 1 of 2 vaccine groups by chance. About half of the volunteers will be placed in the DVC-LVS vaccine group and half of volunteers will be placed in the USAMRIID-LVS vaccine group. Additionally, both groups will receive an injection of placebo (inactive salt water). Study procedures include physical exam and blood and urine samples. Evaluation of the vaccination sites will be performed as well as blood samples to measure the body's response to the vaccine. Participants will be involved in the study for about 6 months.

Conditions

  • Tularaemia

Interventions

OTHER

Placebo

Normal saline will be administered to all subjects as a control and will be given at the same visit as the vaccine (Day 0).

BIOLOGICAL

Undiluted Francisella tularensis live attenuated vaccine

Undiluted Francisella tularensis live attenuated vaccine \[approximately 1x10\^9 colony forming units (cfu)/mL\] produced by Dynport Vaccine Company. Administered by scarification in the ulnar aspect of the volar surface (palm side) of the forearm midway between the wrist and the elbow.

BIOLOGICAL

Undiluted Francisella tularensis live attenuated vaccine

Undiluted Francisella tularensis live attenuated vaccine (approximately 1x10\^9 cfu/mL) in use by the United States Army Medical Research Institute of Infectious Diseases. Administered by scarification in the ulnar aspect of the volar surface (palm side) of the forearm midway between the wrist and the elbow.

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
2010-09-30
Primary Completion
2012-01-31
Completion
2012-01-31

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 NCT01150695 on ClinicalTrials.gov