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Safety Evaluation of a Q-Fever Vaccine

This study has been suspended.
Study NCT00584454.   Last updated on December 20, 2007.   Information provided by U.S. Army Medical Research and Materiel Command

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Descriptive Information Fields
Brief Title  Safety Evaluation of a Q-Fever Vaccine
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
Brief Summary

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.

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.

Study Phase Phase II
Study Type  Interventional
Study Design  Prevention, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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 ]
Secondary Outcome Measure 
Condition  Q Fever
Intervention  Biological: Q-Fever Vaccine
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Suspended
Enrollment  500
Start Date  February 2006
Completion Date February 2011
Eligibility 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.
Gender Both
Ages 17 Years to 65 Years
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00584454
Organization ID A-13480
Secondary IDs †† FY05-14
Study Sponsor  U.S. Army Medical Research and Materiel Command
Collaborators ††
Investigators 
Principal Investigator:     Robert Rivard, MD     USAMRIID Medical Division    
Information Provided By U.S. Army Medical Research and Materiel Command
Verification Date December 2007
First Received Date  December 20, 2007
Last Updated Date December 20, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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