Clinical trial NCT00584454: Safety Evaluation of a Q-fever Vaccine, NDBR 105
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Q Fever
Keywords: Coxiella burnetti, Bacterial Infections, Rickettsia, Hepatits, Endocarditis
Lead sponsor: U.S. Army Medical Research and Development Command
Sponsor class: FED
First posted: 2008-01-02
Enrollment: 10
Sex: ALL
Minimum age (years): 17
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
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.
timeFrame: AEs recorded through day 28 after vaccination; SAEs recorded through duration of study; Confirmed occupational illness recorded through duration of study
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Deterick
country: United States
facility: U.S. Army Medical Research Institute of Infectious Diseases
state: Maryland
Study officials:
affiliation: USAMRIID Medical Division
name: Mark Goldberg, MD
role: PRINCIPAL_INVESTIGATOR
References: