Safety Evaluation of a Q-fever Vaccine, NDBR 105

• 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: U.S. Army Medical Research and Development Command
• Information provided by (Responsible Party): U.S. Army Medical Research and Development Command

Tracking Information

• First Submitted Date: December 20, 2007
• First Posted Date: January 2, 2008
• Results First Submitted Date: November 22, 2016
• Results First Posted Date: March 9, 2017
• Last Update Posted Date: January 3, 2020
• Study Start Date: February 2006
• Actual Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Q Fever

Intervention

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

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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 15, 2016): 10
• Original Estimated Enrollment (submitted: December 20, 2007): 500
• Actual Study Completion Date: June 2014
• Actual Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 17 Years to 65 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00584454
• Other Study ID Numbers: A-13480; FY05-14 ( Other Identifier: USAMRIID )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: U.S. Army Medical Research and Development Command
• Study Sponsor: U.S. Army Medical Research and Development Command
• Collaborators: Not Provided

Investigators

• Principal Investigator: Mark Goldberg, MD; USAMRIID Medical Division

• PRS Account: U.S. Army Medical Research and Development Command
• Verification Date: December 2019