Safety Evaluation of a Q-fever Vaccine, NDBR 105

NCT00584454 | Completed Phase 2 Results

• 2 other identifiers: A-13480FY05-14
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Q Fever

Keywords

Coxiella burnetti, Bacterial Infections, Rickettsia, Hepatits, Endocarditis

Outcome Measures

Primary Outcomes (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.

  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

  AEs recorded through day 28 after vaccination; SAEs recorded through duration of study; Confirmed occupational illness recorded through duration of study

Study Arms (1)

Q Fever Vaccine (NDBR 105)

EXPERIMENTAL

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 Volunteers with skin test reactions will not be vaccinated and withdrawn from the study.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

Interventions

Q Fever Vaccine (NDBR 105 BIOLOGICAL

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.

Q Fever Vaccine (NDBR 105)

Eligibility Criteria

• Age: 17 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command: lead

Study Sites (1)

U.S. Army Medical Research Institute of Infectious Diseases

Fort Deterick, Maryland, 21702, United States

Location

MeSH Terms

Conditions

Q Fever; Bacterial Infections; Endocarditis

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections and Mycoses; Infections; Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: LTC Robert Rivard, MD
• Organization: UAMRIID Division of Medicine

robert.g.rivard.mil@mail.mil

301-619-8244

Study Officials

• Mark Goldberg, MD

  USAMRIID Medical Division

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: January 2, 2008
• Study Start: February 1, 2006
• Primary Completion: July 1, 2009
• Study Completion: June 1, 2014
• Last Updated: January 3, 2020
• Results First Posted: March 9, 2017

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)