Trial record 2 of 3 for:    eee

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2016 by U.S. Army Medical Research and Materiel Command
Sponsor:
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT02654509
First received: January 11, 2016
Last updated: May 25, 2016
Last verified: May 2016
  Purpose
This study is being conducted to collect safety and immunogenicity data for the EEE vaccine.

Condition Intervention Phase
Eastern Equine Encephalitis
Biological: Eastern Equine Encephalitis Vaccine, Inactivated, Dried, TSI-GSD 104
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by U.S. Army Medical Research and Materiel Command:

Primary Outcome Measures:
  • Number of Adverse Events. [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]
  • Number of subjects that develop titers ≥ 1:40 [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Geometric mean of plaque reduction neutralization test (PRNT) 80 titers [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: August 2016
Estimated Study Completion Date: February 2022
Estimated Primary Completion Date: February 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EEE vaccine
Eastern Equine Encephalitis Vaccine will be administered as primary doses of 0.5 mL given subcutaneously in the upper outer aspect of the triceps area and booster doses of 0.1 mL given intradermally in the volar aspect of the forearm. The primary series will be administered on Days 0 and 26-35 with a booster at 6 months. Titers will be collected 28-35 days after the second primary vaccine is < 1:40, the subject will receive a booster dose 28- 90 days of obtaining the titer result.
Biological: Eastern Equine Encephalitis Vaccine, Inactivated, Dried, TSI-GSD 104
Eastern Equine Encephalitis Vaccine, Inactivated, Dried

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02654509

Contacts
Contact: Robert Rivard, MD 301-619-8244 robert.g.rivard.mil@mail.mil

Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Robert Rivard, MD United States Army Medical Research Institute of Infectious Diseases
  More Information

Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT02654509     History of Changes
Other Study ID Numbers: S-14-06 
Study First Received: January 11, 2016
Last Updated: May 25, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Encephalitis
Encephalomyelitis, Equine
Encephalomyelitis, Eastern Equine
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arbovirus Infections
Virus Diseases
Encephalitis, Viral
Central Nervous System Viral Diseases
Alphavirus Infections
Togaviridae Infections
RNA Virus Infections
Infectious Encephalitis
Central Nervous System Infections
Encephalomyelitis
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 21, 2016