Safety and Immunogenicity Study of the Eastern Equine Encephalitis (EEE) Vaccine

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

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

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

138

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • Fort Deterick, Maryland, United States, 21702
        • Special Immunizations Program, Division of Medicine, USAMRIID

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Eastern Equine Encephalitis Vaccine, Inactivated, Dried

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-Vaccination Adverse Events by System Organ Class and Severity
Time Frame: 30 days
The determined adverse events after vaccination (1 month) as reported by participants by severity and system organ class.
30 days
Post-Primary Related Adverse Events by System Organ Class and Severity
Time Frame: 11-13 months
The determined adverse events after primary (11-13 months) as reported by participants by severity and system organ class.
11-13 months
Post-Booster Related Adverse Events by System Organ Class and Severity
Time Frame: 1-5 weeks
The determined adverse events after primary (1-5 weeks) as reported by participants by severity and system organ class.
1-5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% vaccinated subjects with PRNT80 ≥ 1:40 after primary series.
Time Frame: 11-13 months
measure immunogenicity is the 80% plaque-reduction neutralization titer (PRNT80).
11-13 months
% vaccinated subjects with PRNT80 ≥ 1:40 after 6-month booster dose.
Time Frame: 6 months
measure immunogenicity is the 80% plaque-reduction neutralization titer (PRNT80).
6 months
% vaccinated subjects with PRNT80 ≥ 1:40 at 11-13 months after first primary dose.
Time Frame: 11-13 months
measure immunogenicity is the 80% plaque-reduction neutralization titer (PRNT80).
11-13 months
% vaccinated subjects with PRNT80 ≥ 1:40 after week 1, 2, 3, or 4 booster doses.
Time Frame: 1-4 weeks
measure immunogenicity is the 80% plaque-reduction neutralization titer (PRNT80).
1-4 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number (%) of Vaccinated subjects with each Adverse Events.
Time Frame: 11-13 montms
Adverse Event Rates by Series and Sex - Number (%) of Subjects
11-13 montms

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Robert Rivard, MD, US Army Medical Research Institute of Infectious Diseases

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2008

Primary Completion (Actual)

February 16, 2016

Study Completion (Actual)

March 18, 2018

Study Registration Dates

First Submitted

January 11, 2016

First Submitted That Met QC Criteria

January 12, 2016

First Posted (Estimate)

January 13, 2016

Study Record Updates

Last Update Posted (Actual)

March 17, 2020

Last Update Submitted That Met QC Criteria

March 16, 2020

Last Verified

March 1, 2020

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Eastern Equine Encephalitis

Clinical Trials on Eastern Equine Encephalitis Vaccine, Inactivated, Dried, TSI-GSD 104

3
Subscribe