Safety Evaluation of a Q-fever Vaccine, NDBR 105
Condition: Q Fever
MeSH terms: Q Fever; Fever
Intervention: Q Fever Vaccine (NDBR 105
Intervention description: 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 17 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Coxiella burnetti, Bacterial Infections, Rickettsia, Hepatits, Endocarditis

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.
    

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.