- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02466750
Safety and Immunogenicity Study of the Western Equine Encephalitis (WEE) Vaccine
February 10, 2021 updated by: U.S. Army Medical Research and Development Command
Phase 2 Open-Label Safety and Immunogenicity Study of the Western Equine Encephalitis (WEE) Vaccine, Inactivated, Dried, TSI-GSD 210, Lot 3-1-92, in Healthy Adult Subjects at Risk of Exposure to Western Equine Encephalitis Virus
This study is being conducted to collect safety and immunogenicity data for the WEE vaccine, TSI-GSD 210.
Enrollment in this protocol is offered for personnel who enter areas where this virus is used in research or is endemic (an area where this disease process is found to occur frequently).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
500
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Anthony Cardile, DO
- Phone Number: 310-619-8833
- Email: anthony.p.cardile.mil@mail.mil
Study Locations
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-
Maryland
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Fort Deterick, Maryland, United States, 21702
- Recruiting
- Special Immunizations Program, USAMRIID
-
Contact:
- Anthony P. Cardile, DO, MAJ
- Phone Number: 310-619-8833
- Email: anthony.p.cardile.mil@mail.mil
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Be 18 to 65 years old at time of consent.
- Have WEE plaque reduction neutralization 80% titers (PRNT80) < 1:10 for primary series.
- Have WEE PRNT80 < 1:40 for booster series.
- If female of childbearing potential, must agree to have a urine pregnancy test on the same day before each 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 last study treatment (vaccination).
- Be considered at risk for exposure to WEE virus and who have submitted a Request for IND Vaccines for the WEE vaccine.
- Sign and date the approved informed consent document and HIPAA Authorization.
Have in their charts
- medical history (including concomitant medications) within 60 days of planned first administration of vaccine
- physical examination and laboratory tests within 1 year
- previous chest radiograph and electrocardiogram
- Be medically cleared for participation by an investigator. (Examinations and/or tests may be repeated at the discretion of the enrolling physician.)
- Be 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 vaccine for at least 28 days after administration and agree to report all serious adverse events (for example, resulting in hospitalization) for the duration of the subject's participation in the study.
- Agree to defer blood, bone marrow, and organ donation for 1 year after receipt of the vaccine.
Exclusion Criteria:
- Have completed previous WEE vaccine study as a nonresponder (PRNT80 < 1:40).
- Have clinically significant abnormal laboratory 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).
- Have a personal history of an immunodeficiency or received treatment with an immunosuppressive medication, such as systemically administered glucocorticoids (eg, prednisone) within 1 month before planned administration of the vaccine or with other immunosuppressive therapies within 6 months of planned administration of the vaccine. Other immunosuppressive therapies include all cancer chemotherapeutic agents, drugs to prevent transplant rejection, interferons, monoclonal antibodies, protein kinase inhibitors, methotrexate, TNF (tumor necrosis factor) inhibitors, and any other drug determined to be immunosuppressive by the PI. Current administration of topical, inhalational, or intranasal glucocorticoids is not excluded.
- Have a confirmed HIV infection (antibody positivity).
- Have a positive pregnancy test or be a breastfeeding female.
Have any known allergies to components of the vaccine:
formaldehyde eggs neomycin sulfate human serum albumin sodium bisulfite
- Have administration of another vaccine or investigational product within 28 days of WEE vaccination.
- Have any unresolved AE resulting from a previous immunization.
- A medical condition that, in the judgment of the PI, would impact subject safety.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Primary vaccine
Subjects receive 3 doses off WEE vaccine on Day 0, Day 7 ± 2 days, and Day 28-35 days.
A booster will be administered on Day 180 ± 14 days and a sample collected for PRNT80 28-35 days later.
|
Western Equine Encephalitis (WEE) Vaccine, Inactivated, Dried, TSI-GSD 210, Lot 3-1-92
|
Experimental: Booster series
Subjects who previously received the WEE vaccine under another protocol and have a PRNT80 < 1:40.
Boosters (and follow-up titers 28-35 days later) may continue while the subject has titers of < 1:40 for a maximum of 4 booster doses in a year.
If the titer remains < 1:40 after 4 booster doses in 1 year, the subject will not be given WEE vaccine for 1 year.
If the titer is < 1:40 after that interval, one booster dose will be given and the titer will be assayed.
If the immune response to the last booster dose is < 1:40, the subject will be considered to have completed the study as a nonresponder.
|
Western Equine Encephalitis (WEE) Vaccine, Inactivated, Dried, TSI-GSD 210, Lot 3-1-92
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of adverse events
Time Frame: Up to 5 years
|
Up to 5 years
|
|
Percentage of subjects who develop titers of ≥ 1:40 as determined by PRNT80
Time Frame: Up to 5 years
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Immunogenicity data will be collected for all subjects and will be evaluated for all per-protocol subjects.
The primary immunogenicity endpoint measurements will be the percentage of per-protocol subjects who develop titers of ≥ 1:40 as determined by PRNT80 after WEE vaccination at each scheduled time point for which blood samples are drawn and over the entire study period to study completion.
|
Up to 5 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Geometric mean of PRNT80 titers
Time Frame: Up to 5 years
|
The geometric mean PRNT80 titers of per-protocol subjects at each scheduled time point for which blood samples are drawn and over the entire study period to study completion.
|
Up to 5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Anthony Cardile, DO, US Army Medical Research Institute of Infectious Diseases
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 15, 2015
Primary Completion (Anticipated)
June 1, 2021
Study Completion (Anticipated)
December 1, 2021
Study Registration Dates
First Submitted
June 4, 2015
First Submitted That Met QC Criteria
June 8, 2015
First Posted (Estimate)
June 9, 2015
Study Record Updates
Last Update Posted (Actual)
February 11, 2021
Last Update Submitted That Met QC Criteria
February 10, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Encephalitis, Arbovirus
- Encephalitis, Viral
- Central Nervous System Viral Diseases
- Central Nervous System Infections
- Infectious Encephalitis
- Arbovirus Infections
- Vector Borne Diseases
- Encephalomyelitis
- Alphavirus Infections
- Togaviridae Infections
- Encephalitis
- Encephalomyelitis, Equine
- Encephalomyelitis, Western Equine
Other Study ID Numbers
- S-13-06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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