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Safety Evaluation of a Q-fever Vaccine, NDBR 105

This study has suspended participant recruitment.
(Clinical Hold- product related issue)
Sponsor:
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT00584454
First received: December 20, 2007
Last updated: August 21, 2012
Last verified: August 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the safety of Q Fever vaccine, NDBR 105, and collect data on incidence of occupational Q Fever infection in at risk personnel.


Condition Intervention Phase
Q Fever
 Biological: Q-Fever Vaccine, NDBR 105
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Continued Evaluation of the Safety of Q Fever Vaccine, Phase I, Inactivated, Freeze Dried, NDBR 105, in Those at Risk of Exposure to Coxiella Burnetii, A Phase 2 Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by U.S. Army Medical Research and Materiel Command:

Primary Outcome Measures:
  • The adverse reaction and occupational illness endpoint measurements in this Q fever NDBR 105 vaccine study will be evaluated for all intent-to-treat volunteers. [ Time Frame: AEs recorded through day 28 after vaccination; SAEs recorded through duration of study; Confirmed occupational illness recorded through duration of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: February 2006
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Arm
No arms
 Biological: Q-Fever Vaccine, NDBR 105
Each volunteer will receive an intradermal dose of 0.1 ml of the skin test antigen (Q fever Skin Test Antigen, Henzerling Strain, Phase I, MNLBR 110) in the volar aspect of the arm on Day -7 of the study.Volunteers with skin test reactions that are considered negative may be vaccinated with Q Fever Vaccine, Phase I, Inactivated, Freeze-Dried, NDBR 105 (subcutaneously, 0.5 ml) in the upper outer aspect of the arm on Day 0 of the study.

Detailed Description:

Study Objectives:

1. Continue to collect and assess safety data on Q Fever Vaccine, Phase I, Inactivated, Freeze-Dried, NDBR 105, and 2) Provide vaccine that potentially protects personnel at risk for occupational exposure to Q Fever and collect data on incidence of occupational Q Fever infection (subclinical and clinical) in immunized personnel.

  Eligibility

Ages Eligible for Study:   17 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least 18 years old, or if on active military duty, 17 years old.
  • Females of childbearing potential must agree to have a urine pregnancy test on the same day before receipt of skin test antigen AND vaccine. (Exception: documented hysterectomy or > three years of menopause.) The results must be negative.
  • Volunteer must be actively enrolled in the SIP
  • Volunteer must be considered at risk for exposure to C. burnetii.
  • Volunteer must sign and date the approved ICD and HIPAA Authorization.
  • Volunteer must have an up-to-date (within one year) medical history, physical examination, and laboratory tests on their charts and be medically cleared for participation by an Investigator. Examinations or tests may be repeated within one year at the discretion of the enrolling physician.
  • Volunteer must be willing to return for all follow-up visits.
  • Volunteer must agree to report any AEs which may or may not be associated with administration of the test article for at least 28 days after vaccination. All SAEs and UAEs will be reported for the duration of the volunteer's participation in the study (one year).

Exclusion Criteria:

  • Prior history of Q fever disease or vaccination.
  • Clinically significant abnormal lab results including evidence of Hepatitis C, Hepatitis B carrier state, or elevated liver function tests (two times the normal range or at the discretion of the PI).
  • Personal history of an immunodeficiency or current treatment with an immunosuppressive medication or autoimmune disease.
  • Confirmed HIV infection.
  • Heart valve disease: murmur with abnormal echocardiogram (if murmur is detected on examination, volunteer will be referred to cardiologist to rule out pathology.)
  • Positive pregnancy test or lactating female (females must agree to not become pregnant for three months after vaccination.)
  • Any known allergies to components of the vaccine.
  • Administration of another inactivated vaccine within 7 days or a live or IND vaccine within 28 days of Q fever vaccination.
  • Any unresolved AE resulting from a previous immunization.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00584454

Locations
United States, Maryland
U.S. Army Medical Research Institute of Infectious Diseases
Fort Detrick, Maryland, United States, 21702
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Mark Goldberg, MD USAMRIID Medical Division
  More Information

No publications provided

Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT00584454     History of Changes
Other Study ID Numbers: A-13480, FY05-14
Study First Received: December 20, 2007
Last Updated: August 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by U.S. Army Medical Research and Materiel Command:
Coxiella burnetti, Bacterial Infections, Rickettsia, Hepatits, Endocarditis

Additional relevant MeSH terms:
Fever
Q Fever
Body Temperature Changes
 Signs and Symptoms
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on May 19, 2013