Safety Evaluation of a Q-Fever Vaccine - Full Text View

Sponsor:	U.S. Army Medical Research and Materiel Command
Information provided by:	U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:	NCT00584454

Purpose

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.

Condition	Intervention	Phase
Q Fever	Biological: Q-Fever Vaccine	Phase II

Study Type:	Interventional
Study Design:	Prevention, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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

Resource links provided by NLM:

MedlinePlus related topics: Fever

U.S. FDA Resources

Further study details as provided by U.S. Army Medical Research and Materiel Command:

Primary Outcome Measures:

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. [ Time Frame: AEs recorded through day 28 after vaccination; SAEs recorded through duration of study; Confirmed occupational illness recorded through duration of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	500
Study Start Date:	February 2006
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Intervention Details:

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.

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

Ages Eligible for Study:	17 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00584454

Locations

United States, Maryland
U.S. Army Medical Research Institute of Infectious Diseases
Fort Detrick, Maryland, United States, 21702

Sponsors and Collaborators

U.S. Army Medical Research and Materiel Command

Investigators

Principal Investigator:

Robert Rivard, MD

USAMRIID Medical Division

More Information

No publications provided

Responsible Party:	USAMRMC, USAMMDA ( Robert E. Miller, PhD, Sponsor Representative, Director, Division of Regulated Activities and Compliance )
Study ID Numbers:	A-13480, FY05-14
Study First Received:	December 20, 2007
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00584454 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by U.S. Army Medical Research and Materiel Command:

Coxiella burnetti, Bacterial Infections, Rickettsia, Hepatits, Endocarditis

Additional relevant MeSH terms:

Bacterial Infections
Fever
Signs and Symptoms

Q Fever
Body Temperature Changes
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on November 22, 2009