Western Equine EncephalitisPhase 2NCT02466750
Safety and Immunogenicity Study of the Western Equine Encephalitis (WEE) Vaccine
A Phase 2 study testing Western Equine Encephalitis (WEE) Vaccine in people with Western Equine Encephalitis, run by U.S. Army Medical Research and Development Command at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Western Equine Encephalitis
- What is being tested?
- Western Equine Encephalitis (WEE) Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2015to Dec 2021
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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:
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Special Immunizations Program, USAMRIID
Fort Deterick, Maryland, 21702
Anthony P. Cardile, DO, MAJ, 310-619-8833, anthony.p.cardile.mil@mail.mil
About this study
Official title: 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).
- Conditions
- Western Equine Encephalitis
- Being tested
- Western Equine Encephalitis (WEE) Vaccine
- Medical subject headings
- Encephalomyelitis, Western Equine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Western Equine Encephalitis (WEE) VaccineBiological
Western Equine Encephalitis (WEE) Vaccine, Inactivated, Dried, TSI-GSD 210, Lot 3-1-92
| Study group | Role | What they receive |
|---|---|---|
| Primary vaccine | Experimental | 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. Receives: Biological: Western Equine Encephalitis (WEE) Vaccine |
| Booster series | Experimental | 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. Receives: Biological: Western Equine Encephalitis (WEE) Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
Measured: Up to 5 years
Percentage of subjects who develop titers of ≥ 1:40 as determined by PRNT80
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.
Measured: Up to 5 years
Secondary outcomes (1)
Geometric mean of PRNT80 titers
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.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study start15 Dec 2015
- Primary completionJun 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Western Equine EncephalitisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Anthony Cardile, DO, Principal investigator, US Army Medical Research Institute of Infectious Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02466750
- Sponsor's protocol ID
- S-13-06
- Status last verified
- Feb 2021
- First submitted
- 4 Jun 2015
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02466750
- Acronym / sponsor ID
- S-13-06
- Conditions
- Western Equine Encephalitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Study start
- 15 Dec 2015 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 9 Jun 2015 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary vaccine | Experimental | Biological: Western Equine Encephalitis (WEE) VaccineSubjects 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. |
| Booster series | Experimental | Biological: Western Equine Encephalitis (WEE) VaccineSubjects 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
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 |
|---|---|---|
| Western Equine Encephalitis (WEE) VaccineWestern Equine Encephalitis (WEE) Vaccine, Inactivated, Dried, TSI-GSD 210, Lot 3-1-92 | Biological | Booster series, Primary vaccine |
Primary outcome
Number of adverse events
Time frame: Up to 5 years
Percentage of subjects who develop titers of ≥ 1:40 as determined by PRNT80
Time frame: Up to 5 years
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.
1 secondary outcome
Geometric mean of PRNT80 titers
Time frame: Up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
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.
Anthony Cardile, DO principal investigator
US Army Medical Research Institute of Infectious Diseases
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 Western Equine Encephalitis (WEE) Vaccine in people with Western Equine Encephalitis, 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 14 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 11 Feb 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anthony Cardile, DO (310-619-8833, anthony.p.cardile.mil@mail.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events (time frame: Up to 5 years). The study lists 2 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 11 Feb 2021.