Q FeverPhase 2NCT02092142
Safety and Immunogenicity of Q Fever Vaccine
A Phase 2 study testing Q fever Vaccine in people with Q Fever, run by U.S. Army Medical Research and Development Command at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety of Q Fever Vaccine, Phase I, Inactivated, Dried, NDBR 105 and collect data on incidence of occupational Q fever infection in vaccinated personnel. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Q Fever
- What is being tested?
- Q fever Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years old.
- Females of childbearing potential must agree to have a urine pregnancy test on the same day before receipt of skin test AND vaccine. (Exception: documented hysterectomy or ≥ 3 years of menopause.) The results must be negative. Females must agree to not become pregnant for 3 months after receipt of the skin test or vaccination.
- Considered at risk for exposure to C burnetii and who have submitted a Request for Investigational New Drug (IND) Vaccines for the Q Fever vaccine.
- Sign and date the approved informed consent document and Health Insurance Portability and Accountability Act (HIPAA) Authorization.
- Have on their charts:
- Up-to-date medical history (including concomitant medications)
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- Physical examination and laboratory tests within 1 year
- Previous chest x-ray and electrocardiogram
- Be medically cleared for participation by an investigator. Examinations or tests may be repeated at the discretion of the enrolling physician.
- Willing to return for all follow-up visits.
- Agree to report any adverse events (AEs) that may or may not be associated with administration of the test article for at least 28 days after vaccination and agree to report all serious adverse events (for example, resulting in hospitalization) for the duration of the subject's participation in the study (6 months).
- Agree to defer blood, bone marrow, and organ donation for 1 year after receipt of skin test antigen and/or vaccine.
Who cannot join
- 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 principal investigator).
- Personal history of an immunodeficiency or current treatment with an oral or intravenous immunosuppressive medication.
- Confirmed HIV infection.
- Heart valve disease: prosthetic heart valve or clinically significant heart murmur. (If a murmur is detected on examination, an echocardiogram may be obtained or subject may be referred to a cardiologist to determine clinical significance.)
- Aneurysm/vascular graft.
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- Joint prosthesis.
- History of chronic fatigue syndrome (or positive by chronic fatigue syndrome (CFS) Questionnaire criteria).
- Positive pregnancy test or breast-feeding female.
- Any known allergies to components of the vaccine:
- Formalin
- Eggs or chicken products
- Administration of another vaccine or investigational product within 28 days of skin test and subsequent Q fever vaccination.
- Any unresolved AE resulting from a previous immunization.
- Transplant recipients, subjects with cancer, and those with chronic kidney disease.
- A medical condition that, in the judgment of the principal investigator, would impact subject safety.
Trial locations and contacts
1 site in 1 country.
United States1 site
Special Immunizations Program, Division of Medicine, USAMRIID
Fort Deterick, Maryland, 21702
About this study
Official title: Evaluation of the Safety and Immunogenicity of Q Fever Vaccine, Phase I, Inactivated, Dried, NDBR 105, in Subjects at Risk of Exposure to Coxiella Burnetii
The purpose of this study is to evaluate the safety of Q Fever Vaccine, Phase I, Inactivated, Dried, NDBR 105 and collect data on incidence of occupational Q fever infection in vaccinated personnel.
- Conditions
- Q Fever
- Being tested
- Q fever Vaccine
- Keywords
- Q fever, Coxiella burnetii
- Medical subject headings
- Q Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Q fever VaccineBiological
Also called Q fever Vaccine, Phase I, Inactivated, Dried, NDBR 105
Subcutaneous 0.5 mL Q fever Vaccine, Phase I, Inactivated, Dried, NDBR 105
| Study group | Role | What they receive |
|---|---|---|
| Vaccinated | Experimental | The vaccine will be administered subcutaneously in the upper outer aspect of the arm (triceps area) with 0.5 mL Q fever Vaccine, Phase I, Inactivated, Dried, NDBR 105 (which equals 30 μg) Receives: Biological: Q fever Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Immunogenicity
Immune response will be evaluated for per protocol subjects to determine the percentage of subjects who experience a ≥ fourfold rise in immunofluorescence assay (IFA) antibody titer after vaccination. Immunoglobulin M (IgM) at Day 28 or Day 56, or immunoglobulin G (IgG) at 6 months.
Measured: Day 28, Day 56, or 6 months
Percentage of subjects with symptoms following Q fever vaccination
Measured: 6 months
Percentage of subjects with erythema following Q fever vaccination along with severity and association with vaccination
Measured: 6 months
Percentage of subjects with induration following Q fever vaccination along with severity and association with vaccination
Measured: 6 months
Percentage of subjects with each AE, system organ class of AE, severity, and association with vaccination
Measured: 6 months
Percentage of subjects with symptoms following Q fever skin test antigen
Measured: 6 months
Percentage of subjects with erythema following Q fever skin test antigen along with severity and association with skin test antigen
Measured: 6 months
Percentage of subjects with induration following Q fever skin test antigen along with severity and association with skin test antigen
Measured: 6 months
Percentage of subjects with each AE, system organ class of AE, severity, and association with skin test antigen
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startFeb 2006
- Primary completionFeb 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Q FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Collaborators
- US Army Medical Research Institute of Infectious Diseases
- Responsible party
- Sponsor
- Investigators
- Mark J Goldberg, MD, Principal investigator, Special Immunizations Program, USAMRIID
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092142
- Sponsor's protocol ID
- S-11-19
- Other IDs
- FY13-02
- Status last verified
- Dec 2019
- First submitted
- 17 Mar 2014
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Immunogenicity of Q Fever Vaccine, Phase I, Inactivated, Dried, NDBR 105, in Subjects at Risk of Exposure to Coxiella Burnetii
- ClinicalTrials.gov ID
- NCT02092142
- Acronym / sponsor ID
- S-11-19
- Conditions
- Q Fever
- Keywords
- Q fever, Coxiella burnetii
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Collaborators
- US Army Medical Research Institute of Infectious Diseases
- Study start
- Feb 2006
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 20 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety of Q Fever Vaccine, Phase I, Inactivated, Dried, NDBR 105 and collect data on incidence of occupational Q fever infection in vaccinated personnel.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccinated | Experimental | Biological: Q fever VaccineThe vaccine will be administered subcutaneously in the upper outer aspect of the arm (triceps area) with 0.5 mL Q fever Vaccine, Phase I, Inactivated, Dried, NDBR 105 (which equals 30 μg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- At least 18 years old.
- Females of childbearing potential must agree to have a urine pregnancy test on the same day before receipt of skin test AND vaccine. (Exception: documented hysterectomy or ≥ 3 years of menopause.) The results must be negative. Females must agree to not become pregnant for 3 months after receipt of the skin test or vaccination.
- Considered at risk for exposure to C burnetii and who have submitted a Request for Investigational New Drug (IND) Vaccines for the Q Fever vaccine.
- Sign and date the approved informed consent document and Health Insurance Portability and Accountability Act (HIPAA) Authorization.
- Have on their charts:
Key exclusion criteria (16 listed)
- 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 principal investigator).
- Personal history of an immunodeficiency or current treatment with an oral or intravenous immunosuppressive medication.
- Confirmed HIV infection.
- Heart valve disease: prosthetic heart valve or clinically significant heart murmur. (If a murmur is detected on examination, an echocardiogram may be obtained or subject may be referred to a cardiologist to determine clinical significance.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Q fever VaccineAlso: Q fever Vaccine, Phase I, Inactivated, Dried, NDBR 105Subcutaneous 0.5 mL Q fever Vaccine, Phase I, Inactivated, Dried, NDBR 105 | Biological | Vaccinated |
Primary outcome
Change in Immunogenicity
Time frame: Day 28, Day 56, or 6 months
Immune response will be evaluated for per protocol subjects to determine the percentage of subjects who experience a ≥ fourfold rise in immunofluorescence assay (IFA) antibody titer after vaccination. Immunoglobulin M (IgM) at Day 28 or Day 56, or immunoglobulin G (IgG) at 6 months.
Percentage of subjects with symptoms following Q fever vaccination
Time frame: 6 months
Percentage of subjects with erythema following Q fever vaccination along with severity and association with vaccination
Time frame: 6 months
Percentage of subjects with induration following Q fever vaccination along with severity and association with vaccination
Time frame: 6 months
Percentage of subjects with each AE, system organ class of AE, severity, and association with vaccination
Time frame: 6 months
Percentage of subjects with symptoms following Q fever skin test antigen
Time frame: 6 months
Percentage of subjects with erythema following Q fever skin test antigen along with severity and association with skin test antigen
Time frame: 6 months
Percentage of subjects with induration following Q fever skin test antigen along with severity and association with skin test antigen
Time frame: 6 months
Percentage of subjects with each AE, system organ class of AE, severity, and association with skin test antigen
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark J Goldberg, MD principal investigator
Special Immunizations Program, USAMRIID
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Q fever Vaccine in people with Q Fever, run by U.S. Army Medical Research and Development Command at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Immunogenicity (time frame: Day 28, Day 56, or 6 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2020.