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Safety Evaluation of a Q-fever Vaccine, NDBR 105

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00584454
Recruitment Status : Completed
First Posted : January 2, 2008
Results First Posted : March 9, 2017
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
U.S. Army Medical Research and Development Command

Tracking Information
First Submitted Date  ICMJE December 20, 2007
First Posted Date  ICMJE January 2, 2008
Results First Submitted Date  ICMJE November 22, 2016
Results First Posted Date  ICMJE March 9, 2017
Last Update Posted Date January 3, 2020
Study Start Date  ICMJE February 2006
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2017)
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 ]
Observe adverse reactions and occupational illness endpoint measurements 7 days follow-up after receipt of skin test antigen and 12 months of follow-up after receipt of vaccine
Original Primary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Evaluation of a Q-fever Vaccine, NDBR 105
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Q Fever
Intervention  ICMJE Biological: Q Fever Vaccine (NDBR 105
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.
Study Arms  ICMJE Experimental: Q Fever Vaccine (NDBR 105)
Volunteers will receive and intradermal dose of 0.1 ml of the skin test antigen (Q fever Skin Test Antigen, Henzerling Strain, Phase 1, MNLBR 110) in the volar aspect of the arm. Skin test will be evaluated; if erythema occurs after the skin test, it is medically contraindicated to vaccinate that volunteer. Volunteers with skin test reactions will not be vaccinated and withdrawn from the study.
Intervention: Biological: Q Fever Vaccine (NDBR 105
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 15, 2016)
10
Original Estimated Enrollment  ICMJE
 (submitted: December 20, 2007)
500
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 17 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00584454
Other Study ID Numbers  ICMJE A-13480
FY05-14 ( Other Identifier: USAMRIID )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party U.S. Army Medical Research and Development Command
Study Sponsor  ICMJE U.S. Army Medical Research and Development Command
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mark Goldberg, MD USAMRIID Medical Division
PRS Account U.S. Army Medical Research and Development Command
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP