CompletedNCT00584454Updated Jan 3, 2020Results posted

Safety Evaluation of a Q-fever Vaccine, NDBR 105

A Phase 2 interventional study of Q Fever Vaccine (NDBR 105 in Q Fever, sponsored by U.S. Army Medical Research and Development Command. Completed at 1 site in United States. Open to participants aged 17 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-03.

Sponsored by U.S. Army Medical Research and Development Command · Phase 2, Interventional, and Prevention

Phase: Phase 2
Study type: Interventional
Enrollment: 10
Allocation: Not applicable
Ages: 17 Years to 65 Years
Sex: All

Study 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.

Read the detailed description

Study Objectives:

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.

Conditions studied

Q Fever

Browse trials for

Fever 601

Keywords

Coxiella burnetti, Bacterial Infections, Rickettsia, Hepatits, Endocarditis

In context

Fever

601 studies on the registry are indexed under Fever; 101 are open to participants now.

This study's enrollment of 10 is below the median of 100 across 382 interventional studies indexed under Fever.

Browse Fever studies →

Lead sponsor

U.S. Army Medical Research and Development Command is the lead sponsor of 151 studies on the registry; 8 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 16 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 17 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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.

Study design

Phase: Phase 2
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 10 participants (actual)

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.
Biological: Q Fever Vaccine (NDBR 105

Interventions

BiologicalQ 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.

What researchers measure

Primary outcomes

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

Results

Posted Mar 9, 2017

Participant flow

10 subject with negative skin test antigen were enrolled in this study

Participant flow — Overall Study
Milestone	Q Fever Vaccine (NDBR 105)
Started	10
Completed	6
Not completed	4
Withdrew: Adverse event	1
Withdrew: Relocation	1
Withdrew: Clinical hold	2

Outcome measures

PrimaryThe 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

Time frame:: AEs recorded through day 28 after vaccination; SAEs recorded through duration of study; Confirmed occupational illness recorded through duration of study
Reported as:: Count of participants · Participants

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.
Participants	Q Fever Vaccine (NDBR 105)
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.	10

Adverse events

Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Q Fever Vaccine (NDBR 105)	—	1/10 (10%)	10/10 (100%)

Most frequent serious events

Most frequent serious events
Event	Q Fever Vaccine (NDBR 105)
ChillsGeneral disorders	1/10
ParaesthesiaNervous system disorders	1/10
MalaiseGeneral disorders	1/10

Most frequent other events

Showing 10 of 22

Most frequent other events
Event	Q Fever Vaccine (NDBR 105)
Injection Site ErythemaGeneral disorders	1/10
Injection Site HaematomaGeneral disorders	1/10
Upper Respiratory Tract InfectionInfections and infestations	1/10
NauseaGastrointestinal disorders	1/10
HeadacheNervous system disorders	1/10
FatigueGeneral disorders	1/10
Injection site painGeneral disorders	1/10
Injection site indurationGeneral disorders	1/10
Neck painMusculoskeletal and connective tissue disorders	1/10
MalaiseGeneral disorders	1/10

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Q Fever Vaccine (NDBR 105)
<=18 years	0
Between 18 and 65 years	10
>=65 years	0

Sex: Female, Male
Sex: Female, Male(Participants)	Q Fever Vaccine (NDBR 105)
Female	1
Male	9

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Q Fever Vaccine (NDBR 105)
Hispanic or Latino	0
Not Hispanic or Latino	10
Unknown or Not Reported	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Q Fever Vaccine (NDBR 105)
American Indian or Alaska Native	0
Asian	0
Native Hawaiian or Other Pacific Islander	0
Black or African American	1
White	9
More than one race	0
Unknown or Not Reported	0

Region of Enrollment
Region of Enrollment(participants)	Q Fever Vaccine (NDBR 105)
United States	10

Study locations

1 site

U.S. Army Medical Research Institute of Infectious Diseases
Fort Deterick, Maryland 21702, United States

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00584454
Lead sponsor: U.S. Army Medical Research and Development Command
Responsible party: Sponsor
First posted: Jan 2, 2008
Start date: Feb 2006
Primary completion: Jul 2009
Completion: Jun 2014
Results posted: Mar 9, 2017
Last update: Jan 3, 2020

Study contacts

Mark Goldberg, MD

principal investigator · USAMRIID Medical Division

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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