Safety Evaluation of a Q-fever Vaccine, NDBR 105

Completed · Phase 2

Conditions studied: Q Fever

In brief

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.

Key facts

Study ID

NCT00584454

Run by

U.S. Army Medical Research and Development Command

People needed

10

Starts

2006-02-01

Expected to finish

2014-06-01

Last updated by the study team

2020-01-03

Who can join

Age: 17 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• U.S. Army Medical Research Institute of Infectious Diseases — Fort Deterick, Maryland, United States

Full record on ClinicalTrials.gov

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