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

March 16, 2020 updated by: U.S. Army Medical Research and Development Command

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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
138

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
U.S. Army Medical Research and Development Command

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 3, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 16, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 18, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 13, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A-14568.a

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.

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