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Safety Evaluation of a Q-fever Vaccine, NDBR 105

Primary Purpose

Q Fever

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Q Fever Vaccine (NDBR 105

About this trial

This is an interventional prevention trial for Q Fever focused on measuring Coxiella burnetti, Bacterial Infections, Rickettsia, Hepatits, Endocarditis

Eligibility Criteria

17 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

U.S. Army Medical Research Institute of Infectious Diseases

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Q Fever Vaccine (NDBR 105)

Arm Description

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.

Outcomes

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.

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00584454

First Posted

December 20, 2007

Last Updated

December 30, 2019

Sponsor

U.S. Army Medical Research and Development Command

1. Study Identification

Unique Protocol Identification Number

NCT00584454

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

February 2006 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

U.S. Army Medical Research and Development Command

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Q Fever

Keywords

Coxiella burnetti, Bacterial Infections, Rickettsia, Hepatits, Endocarditis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Q Fever Vaccine (NDBR 105)

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Q Fever Vaccine (NDBR 105

Intervention Description

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.

Primary Outcome Measure Information:

Title

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.

Description

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

17 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Goldberg, MD

Organizational Affiliation

USAMRIID Medical Division

Official's Role

Principal Investigator

Facility Information:

Facility Name

U.S. Army Medical Research Institute of Infectious Diseases

City

Fort Deterick

State/Province

Maryland

ZIP/Postal Code

21702

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Safety Evaluation of a Q-fever Vaccine, NDBR 105

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