Clinical trial NCT02654509: Safety and Immunogenicity Study of the Eastern Equine Encephalitis (EEE) Vaccine
Official title: Phase 2 Open-Label Safety and Immunogenicity Study of the Eastern Equine Encephalitis (EEE) Vaccine, Inactivated, Dried, TSI-GSD 104, Lot 2-1-89, in Healthy Adult Subjects at Risk of Exposure to Eastern Equine Encephalitis Virus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Eastern Equine Encephalitis
Lead sponsor: U.S. Army Medical Research and Development Command
Sponsor class: FED
First posted: 2016-01-13
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study is being conducted to collect safety and immunogenicity data for the Eastern Equine Encephalitis (EEE) vaccine.

Detailed description: This study is being conducted to collect safety and immunogenicity data for the Eastern Equine Encephalitis (EEE) vaccine. To determine the frequency of adverse events in this Eastern Equine Encephalitis (EEE) vaccine study for all intent-to-treat subjects will be evaluated. Also the frequency of clinically confirmed and documented cases of Eastern Equine Encephalitis (EEE) disease among vaccinated subjects compliant with titer schedule after working with Eastern Equine Encephalitis (EEE) virus.

Eligibility criteria: Inclusion Criteria:

1. Be 18 to 65 years old at time of consent.
2. Have EEE virus plaque reduction neutralization 80% titers (PRNT80) \< 1:20 for primary series.
3. Have EEE virus 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 not to become pregnant for 3 months after receipt of the last study treatment (vaccination).
5. Be considered at risk for exposure to EEE virus and who have submitted a Request for IND Vaccines for the EEE vaccine.
6. Sign and date the approved informed consent document and HIPAA Authorization.
7. 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 results and electrocardiogram
8. Be medically cleared for participation by an investigator. (Examinations and/or tests may be repeated at the discretion of the principal investigator \[PI\].)
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. Subjects must agree to report any pregnancy that occurs within 3 months after a vaccination.
11. Agree to defer blood, bone marrow, and organ donation for 1 year after receipt of the vaccine.

Exclusion Criteria:

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

   * Neomycin sulfate
   * Formaldehyde
   * Egg
   * Human serum albumin
   * Sodium bisulfite
7. Have administration of another vaccine or investigational product within 28 days of EEE vaccination.
8. Have any unresolved AE resulting from a previous immunization.
9. Have a medical condition that, in the judgment of the PI, would impact subject safety.

Primary outcomes:
measure: Post-Vaccination Adverse Events by System Organ Class and Severity
timeFrame: 30 days
measure: Post-Primary Related Adverse Events by System Organ Class and Severity
timeFrame: 11-13 months
measure: Post-Booster Related Adverse Events by System Organ Class and Severity
timeFrame: 1-5 weeks
Secondary outcomes:
measure: % vaccinated subjects with PRNT80 ≥ 1:40 after primary series.
timeFrame: 11-13 months
measure: % vaccinated subjects with PRNT80 ≥ 1:40 after 6-month booster dose.
timeFrame: 6 months
measure: % vaccinated subjects with PRNT80 ≥ 1:40 at 11-13 months after first primary dose.
timeFrame: 11-13 months
measure: % vaccinated subjects with PRNT80 ≥ 1:40 after week 1, 2, 3, or 4 booster doses.
timeFrame: 1-4 weeks
Other outcomes:
measure: Number (%) of Vaccinated subjects with each Adverse Events.
timeFrame: 11-13 montms
Locations:
city: Fort Deterick
country: United States
facility: Special Immunizations Program, Division of Medicine, USAMRIID
state: Maryland
Study officials:
affiliation: US Army Medical Research Institute of Infectious Diseases
name: Robert Rivard, MD
role: PRINCIPAL_INVESTIGATOR
References: