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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

December 20, 2007
August 21, 2012
February 2006
December 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00584454 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety Evaluation of a Q-fever Vaccine, NDBR 105
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

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.

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.
Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Q Fever
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.
No Arm
No arms
Intervention: Biological: Q-Fever Vaccine, NDBR 105
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
500
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
17 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00584454
A-13480, FY05-14
No
U.S. Army Medical Research and Materiel Command
U.S. Army Medical Research and Materiel Command
Not Provided
Principal Investigator: Mark Goldberg, MD USAMRIID Medical Division
U.S. Army Medical Research and Materiel Command
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP