Clinical trial NCT02466750: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Western Equine Encephalitis
Lead sponsor: U.S. Army Medical Research and Development Command
Sponsor class: FED
First posted: 2015-06-09
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


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.

Primary outcomes:
measure: Number of adverse events
timeFrame: Up to 5 years
measure: Percentage of subjects who develop titers of ≥ 1:40 as determined by PRNT80
timeFrame: Up to 5 years
Secondary outcomes:
measure: Geometric mean of PRNT80 titers
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Fort Deterick
country: United States
facility: Special Immunizations Program, USAMRIID
state: Maryland
Study officials:
affiliation: US Army Medical Research Institute of Infectious Diseases
name: Anthony Cardile, DO
role: PRINCIPAL_INVESTIGATOR
References: