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

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

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).
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Number of adverse events

Secondary Outcome

 Geometric mean of PRNT80 titers

Condition

Western Equine Encephalitis

Intervention

Western Equine Encephalitis (WEE) Vaccine

Study Arms / Comparison Groups

 Primary vaccine
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

500

Start Date

December 15, 2015

Completion Date

December 2021

Primary Completion Date

June 2021

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Anthony Cardile, DO, 310-619-8833, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02466750

Organization ID

S-13-06


Responsible Party

Sponsor

Study Sponsor

U.S. Army Medical Research and Development Command


Study Sponsor

Anthony Cardile, DO, Principal Investigator, US Army Medical Research Institute of Infectious Diseases


Verification Date

February 2021