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.
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.
- 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).
- 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.