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Safety and Immunogenicity Study of the Western Equine Encephalitis (WEE) Vaccine

Primary Purpose

Western Equine Encephalitis

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Western Equine Encephalitis (WEE) Vaccine
Sponsored by
U.S. Army Medical Research and Development Command
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Western Equine Encephalitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Be 18 to 65 years old at time of consent.
  2. Have WEE plaque reduction neutralization 80% titers (PRNT80) < 1:10 for primary series.
  3. Have WEE PRNT80 < 1:40 for booster series.
  4. 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).
  5. Be considered at risk for exposure to WEE virus and who have submitted a Request for IND Vaccines for the WEE vaccine.
  6. Sign and date the approved informed consent document and HIPAA Authorization.
  7. Have in their charts

    1. medical history (including concomitant medications) within 60 days of planned first administration of vaccine
    2. physical examination and laboratory tests within 1 year
    3. previous chest radiograph and electrocardiogram
  8. Be medically cleared for participation by an investigator. (Examinations and/or tests may be repeated at the discretion of the enrolling physician.)
  9. Be willing to return for all follow-up visits.
  10. 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.
  11. Agree to defer blood, bone marrow, and organ donation for 1 year after receipt of the vaccine.

Exclusion Criteria:

  1. Have completed previous WEE vaccine study as a nonresponder (PRNT80 < 1:40).
  2. 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).
  3. 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.
  4. Have a confirmed HIV infection (antibody positivity).
  5. Have a positive pregnancy test or be a breastfeeding female.
  6. Have any known allergies to components of the vaccine:

    formaldehyde eggs neomycin sulfate human serum albumin sodium bisulfite

  7. Have administration of another vaccine or investigational product within 28 days of WEE vaccination.
  8. Have any unresolved AE resulting from a previous immunization.
  9. A medical condition that, in the judgment of the PI, would impact subject safety.

Sites / Locations

  • Special Immunizations Program, USAMRIIDRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Primary vaccine

Booster series

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of adverse events
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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 4, 2015
Last Updated
February 10, 2021
Sponsor
U.S. Army Medical Research and Development Command
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1. Study Identification

Unique Protocol Identification Number
NCT02466750
Brief Title
Safety and Immunogenicity Study of the Western Equine Encephalitis (WEE) Vaccine
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 15, 2015 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
U.S. Army Medical Research and Development Command

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Western Equine Encephalitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Primary vaccine
Arm Type
Experimental
Arm Description
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.
Arm Title
Booster series
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Western Equine Encephalitis (WEE) Vaccine
Intervention Description
Western Equine Encephalitis (WEE) Vaccine, Inactivated, Dried, TSI-GSD 210, Lot 3-1-92
Primary Outcome Measure Information:
Title
Number of adverse events
Time Frame
Up to 5 years
Title
Percentage of subjects who develop titers of ≥ 1:40 as determined by PRNT80
Description
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.
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Geometric mean of PRNT80 titers
Description
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.
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anthony Cardile, DO
Phone
310-619-8833
Email
anthony.p.cardile.mil@mail.mil
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Cardile, DO
Organizational Affiliation
US Army Medical Research Institute of Infectious Diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
Special Immunizations Program, USAMRIID
City
Fort Deterick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony P. Cardile, DO, MAJ
Phone
310-619-8833
Email
anthony.p.cardile.mil@mail.mil

12. IPD Sharing Statement

Learn more about this trial

Safety and Immunogenicity Study of the Western Equine Encephalitis (WEE) Vaccine

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