Clinical trial NCT02092142: Safety and Immunogenicity of Q Fever Vaccine
Official title: Evaluation of the Safety and Immunogenicity of Q Fever Vaccine, Phase I, Inactivated, Dried, NDBR 105, in Subjects at Risk of Exposure to Coxiella Burnetii
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Q Fever
Keywords: Q fever
Coxiella burnetii
Lead sponsor: U.S. Army Medical Research and Development Command
Sponsor class: FED
Collaborators: name: US Army Medical Research Institute of Infectious Diseases
First posted: 2014-03-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: 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, Phase I, Inactivated, Dried, NDBR 105 and collect data on incidence of occupational Q fever infection in vaccinated personnel.


Eligibility criteria: Inclusion Criteria:

* At least 18 years old.
* Females of childbearing potential must agree to have a urine pregnancy test on the same day before receipt of skin test AND vaccine. (Exception: documented hysterectomy or ≥ 3 years of menopause.) The results must be negative. Females must agree to not become pregnant for 3 months after receipt of the skin test or vaccination.
* Considered at risk for exposure to C burnetii and who have submitted a Request for Investigational New Drug (IND) Vaccines for the Q Fever vaccine.
* Sign and date the approved informed consent document and Health Insurance Portability and Accountability Act (HIPAA) Authorization.
* Have on their charts:

  * Up-to-date medical history (including concomitant medications)
  * Physical examination and laboratory tests within 1 year
  * Previous chest x-ray and electrocardiogram
* Be medically cleared for participation by an investigator. Examinations or tests may be repeated at the discretion of the enrolling physician.
* Willing to return for all follow-up visits.
* Agree to report any adverse events (AEs) that may or may not be associated with administration of the test article for at least 28 days after vaccination and agree to report all serious adverse events (for example, resulting in hospitalization) for the duration of the subject's participation in the study (6 months).
* Agree to defer blood, bone marrow, and organ donation for 1 year after receipt of skin test antigen and/or vaccine.

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 principal investigator).
* Personal history of an immunodeficiency or current treatment with an oral or intravenous immunosuppressive medication.
* Confirmed HIV infection.
* Heart valve disease: prosthetic heart valve or clinically significant heart murmur. (If a murmur is detected on examination, an echocardiogram may be obtained or subject may be referred to a cardiologist to determine clinical significance.)
* Aneurysm/vascular graft.
* Joint prosthesis.
* History of chronic fatigue syndrome (or positive by chronic fatigue syndrome (CFS) Questionnaire criteria).
* Positive pregnancy test or breast-feeding female.
* Any known allergies to components of the vaccine:

  * Formalin
  * Eggs or chicken products
* Administration of another vaccine or investigational product within 28 days of skin test and subsequent Q fever vaccination.
* Any unresolved AE resulting from a previous immunization.
* Transplant recipients, subjects with cancer, and those with chronic kidney disease.
* A medical condition that, in the judgment of the principal investigator, would impact subject safety.

Primary outcomes:
measure: Change in Immunogenicity
timeFrame: Day 28, Day 56, or 6 months
measure: Percentage of subjects with symptoms following Q fever vaccination
timeFrame: 6 months
measure: Percentage of subjects with erythema following Q fever vaccination along with severity and association with vaccination
timeFrame: 6 months
measure: Percentage of subjects with induration following Q fever vaccination along with severity and association with vaccination
timeFrame: 6 months
measure: Percentage of subjects with each AE, system organ class of AE, severity, and association with vaccination
timeFrame: 6 months
measure: Percentage of subjects with symptoms following Q fever skin test antigen
timeFrame: 6 months
measure: Percentage of subjects with erythema following Q fever skin test antigen along with severity and association with skin test antigen
timeFrame: 6 months
measure: Percentage of subjects with induration following Q fever skin test antigen along with severity and association with skin test antigen
timeFrame: 6 months
measure: Percentage of subjects with each AE, system organ class of AE, severity, and association with skin test antigen
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Deterick
country: United States
facility: Special Immunizations Program, Division of Medicine, USAMRIID
state: Maryland
Study officials:
affiliation: Special Immunizations Program, USAMRIID
name: Mark J Goldberg, MD
role: PRINCIPAL_INVESTIGATOR
References: