Safety and Immunogenicity Study of the Eastern Equine Encephalitis (EEE) Vaccine
Primary Purpose
Eastern Equine Encephalitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Eastern Equine Encephalitis Vaccine, Inactivated, Dried, TSI-GSD 104
Sponsored by
About this trial
This is an interventional prevention trial for Eastern Equine Encephalitis
Eligibility Criteria
Inclusion Criteria:
- Be 18 to 65 years old at time of consent.
- Have EEE virus plaque reduction neutralization 80% titers (PRNT80) < 1:20 for primary series.
- Have EEE virus PRNT80 < 1:40 for booster series.
- 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).
- Be considered at risk for exposure to EEE virus and who have submitted a Request for IND Vaccines for the EEE vaccine.
- Sign and date the approved informed consent document and HIPAA Authorization.
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
- Be medically cleared for participation by an investigator. (Examinations and/or tests may be repeated at the discretion of the principal investigator [PI].)
- Be willing to return for all follow-up visits.
- 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.
- Agree to defer blood, bone marrow, and organ donation for 1 year after receipt of the vaccine.
Exclusion Criteria:
- Have completed previous EEE vaccine study as a nonresponder.
- 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).
- 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.
- Have confirmed HIV infection (antibody positivity).
- Have positive pregnancy test or be a breastfeeding female.
Have any known allergies to components of the vaccine:
- Neomycin sulfate
- Formaldehyde
- Egg
- Human serum albumin
- Sodium bisulfite
- Have administration of another vaccine or investigational product within 28 days of EEE vaccination.
- Have any unresolved AE resulting from a previous immunization.
- Have a medical condition that, in the judgment of the PI, would impact subject safety.
Sites / Locations
- Special Immunizations Program, Division of Medicine, USAMRIID
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EEE vaccine
Arm Description
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.
Outcomes
Primary Outcome Measures
Post-Vaccination Adverse Events by System Organ Class and Severity
The determined adverse events after vaccination (1 month) as reported by participants by severity and system organ class.
Post-Primary Related Adverse Events by System Organ Class and Severity
The determined adverse events after primary (11-13 months) as reported by participants by severity and system organ class.
Post-Booster Related Adverse Events by System Organ Class and Severity
The determined adverse events after primary (1-5 weeks) as reported by participants by severity and system organ class.
Secondary Outcome Measures
% vaccinated subjects with PRNT80 ≥ 1:40 after primary series.
measure immunogenicity is the 80% plaque-reduction neutralization titer (PRNT80).
% vaccinated subjects with PRNT80 ≥ 1:40 after 6-month booster dose.
measure immunogenicity is the 80% plaque-reduction neutralization titer (PRNT80).
% vaccinated subjects with PRNT80 ≥ 1:40 at 11-13 months after first primary dose.
measure immunogenicity is the 80% plaque-reduction neutralization titer (PRNT80).
% vaccinated subjects with PRNT80 ≥ 1:40 after week 1, 2, 3, or 4 booster doses.
measure immunogenicity is the 80% plaque-reduction neutralization titer (PRNT80).
Full Information
NCT ID
NCT02654509
First Posted
January 11, 2016
Last Updated
March 16, 2020
Sponsor
U.S. Army Medical Research and Development Command
1. Study Identification
Unique Protocol Identification Number
NCT02654509
Brief Title
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
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 3, 2008 (Actual)
Primary Completion Date
February 16, 2016 (Actual)
Study Completion Date
March 18, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
U.S. Army Medical Research and Development Command
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eastern Equine Encephalitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
138 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EEE vaccine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Eastern Equine Encephalitis Vaccine, Inactivated, Dried, TSI-GSD 104
Intervention Description
Eastern Equine Encephalitis Vaccine, Inactivated, Dried
Primary Outcome Measure Information:
Title
Post-Vaccination Adverse Events by System Organ Class and Severity
Description
The determined adverse events after vaccination (1 month) as reported by participants by severity and system organ class.
Time Frame
30 days
Title
Post-Primary Related Adverse Events by System Organ Class and Severity
Description
The determined adverse events after primary (11-13 months) as reported by participants by severity and system organ class.
Time Frame
11-13 months
Title
Post-Booster Related Adverse Events by System Organ Class and Severity
Description
The determined adverse events after primary (1-5 weeks) as reported by participants by severity and system organ class.
Time Frame
1-5 weeks
Secondary Outcome Measure Information:
Title
% vaccinated subjects with PRNT80 ≥ 1:40 after primary series.
Description
measure immunogenicity is the 80% plaque-reduction neutralization titer (PRNT80).
Time Frame
11-13 months
Title
% vaccinated subjects with PRNT80 ≥ 1:40 after 6-month booster dose.
Description
measure immunogenicity is the 80% plaque-reduction neutralization titer (PRNT80).
Time Frame
6 months
Title
% vaccinated subjects with PRNT80 ≥ 1:40 at 11-13 months after first primary dose.
Description
measure immunogenicity is the 80% plaque-reduction neutralization titer (PRNT80).
Time Frame
11-13 months
Title
% vaccinated subjects with PRNT80 ≥ 1:40 after week 1, 2, 3, or 4 booster doses.
Description
measure immunogenicity is the 80% plaque-reduction neutralization titer (PRNT80).
Time Frame
1-4 weeks
Other Pre-specified Outcome Measures:
Title
Number (%) of Vaccinated subjects with each Adverse Events.
Description
Adverse Event Rates by Series and Sex - Number (%) of Subjects
Time Frame
11-13 montms
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Be 18 to 65 years old at time of consent.
Have EEE virus plaque reduction neutralization 80% titers (PRNT80) < 1:20 for primary series.
Have EEE virus PRNT80 < 1:40 for booster series.
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).
Be considered at risk for exposure to EEE virus and who have submitted a Request for IND Vaccines for the EEE vaccine.
Sign and date the approved informed consent document and HIPAA Authorization.
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
Be medically cleared for participation by an investigator. (Examinations and/or tests may be repeated at the discretion of the principal investigator [PI].)
Be willing to return for all follow-up visits.
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.
Agree to defer blood, bone marrow, and organ donation for 1 year after receipt of the vaccine.
Exclusion Criteria:
Have completed previous EEE vaccine study as a nonresponder.
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).
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.
Have confirmed HIV infection (antibody positivity).
Have positive pregnancy test or be a breastfeeding female.
Have any known allergies to components of the vaccine:
Neomycin sulfate
Formaldehyde
Egg
Human serum albumin
Sodium bisulfite
Have administration of another vaccine or investigational product within 28 days of EEE vaccination.
Have any unresolved AE resulting from a previous immunization.
Have a medical condition that, in the judgment of the PI, would impact subject safety.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Rivard, MD
Organizational Affiliation
US Army Medical Research Institute of Infectious Diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
Special Immunizations Program, Division of Medicine, USAMRIID
City
Fort Deterick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Immunogenicity Study of the Eastern Equine Encephalitis (EEE) Vaccine
We'll reach out to this number within 24 hrs