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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Q Fever	Biological: Q Fever Vaccine (NDBR 105	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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 Start Date: February 2006
• Actual Primary Completion Date: July 2009
• Actual Study Completion Date: June 2014

Arms and Interventions

Arm

Intervention/treatment

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 Volunteers with skin test reactions will not be vaccinated and withdrawn from the study.

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.

Outcome Measures

Primary Outcome Measures :

1. 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

Eligibility Criteria

• Ages Eligible for Study: 17 Years to 65 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Maryland

U.S. Army Medical Research Institute of Infectious Diseases

Fort Deterick, Maryland, United States, 21702

Sponsors and Collaborators

U.S. Army Medical Research and Development Command

Investigators

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

More Information

• Responsible Party: U.S. Army Medical Research and Development Command
• ClinicalTrials.gov Identifier: NCT00584454
• Other Study ID Numbers: A-13480; FY05-14 ( Other Identifier: USAMRIID )
• First Posted: January 2, 2008
• Results First Posted: March 9, 2017
• Last Update Posted: January 3, 2020
• Last Verified: December 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Coxiella burnetti, Bacterial Infections, Rickettsia, Hepatits, Endocarditis

Additional relevant MeSH terms:

Q Fever; Fever; Body Temperature Changes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections