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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

Study Type Interventional
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
Enrollment 10
Recruitment Details 10 subject with negative skin test antigen were enrolled in this study
Pre-assignment Details Patients were excluded from this study if after the skin test antigen erythema (> 30mm) or induration (> 20 mm) occured
Arm/Group Title Q Fever Vaccine (NDBR 105)
Hide Arm/Group 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 Volunteers with skin test reactions will not be vaccinated and withdrawn from the study.

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.
Period Title: Overall Study
Started 10
Completed 6
Not Completed 4
Reason Not Completed
Adverse Event             1
Relocation             1
Clinical Hold             2
Arm/Group Title Q Fever Vaccine (NDBR 105)
Hide Arm/Group 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.

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.
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
1
  10.0%
Male
9
  90.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
10
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
  10.0%
White
9
  90.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
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.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects at risk of exposure to Coxiella Burnetti (Q Fever)
Arm/Group Title Q Fever Vaccine (NDBR 105)
Hide Arm/Group 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.

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.
Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
10
 100.0%
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Q Fever Vaccine (NDBR 105)
Hide Arm/Group 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.

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.
All-Cause Mortality
Q Fever Vaccine (NDBR 105)
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Q Fever Vaccine (NDBR 105)
Affected / at Risk (%) # Events
Total   1/10 (10.00%)    
General disorders   
Chills *  1/10 (10.00%)  1
Malaise *  1/10 (10.00%)  1
Nervous system disorders   
Paraesthesia *  1/10 (10.00%)  1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Q Fever Vaccine (NDBR 105)
Affected / at Risk (%) # Events
Total   10/10 (100.00%)    
Gastrointestinal disorders   
Nausea *  1/10 (10.00%)  1
Abdominal pain *  1/10 (10.00%)  1
Diarrhea *  1/10 (10.00%)  1
General disorders   
Injection Site Erythema *  1/10 (10.00%)  1
Injection Site Haematoma *  1/10 (10.00%)  1
Fatigue *  1/10 (10.00%)  1
Injection site pain *  1/10 (10.00%)  1
Injection site induration *  1/10 (10.00%)  1
Malaise *  1/10 (10.00%)  1
Pyrexia *  1/10 (10.00%)  1
Injection site warmth *  1/10 (10.00%)  1
Injection site pruritus *  1/10 (10.00%)  1
Thirst *  1/10 (10.00%)  1
Infections and infestations   
Upper Respiratory Tract Infection *  1/10 (10.00%)  1
Metabolism and nutrition disorders   
Decreased appetite *  1/10 (10.00%)  1
Musculoskeletal and connective tissue disorders   
Neck pain *  1/10 (10.00%)  1
Myalgia *  1/10 (10.00%)  1
Muscle twitching *  1/10 (10.00%)  1
Nervous system disorders   
Headache *  1/10 (10.00%)  1
Disturbance in attention *  1/10 (10.00%)  1
Dizziness *  1/10 (10.00%)  1
Psychiatric disorders   
Restlessness *  1/10 (10.00%)  1
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: LTC Robert Rivard, MD
Organization: UAMRIID Division of Medicine
Phone: 301-619-8244
EMail: robert.g.rivard.mil@mail.mil
Layout table for additonal 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 Submitted: December 20, 2007
First Posted: January 2, 2008
Results First Submitted: November 22, 2016
Results First Posted: March 9, 2017
Last Update Posted: January 3, 2020