- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02654509
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
Completed
Conditions
Intervention / Treatment
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:
- 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.
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
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Encephalitis, Arbovirus
- Encephalitis, Viral
- Central Nervous System Viral Diseases
- Central Nervous System Infections
- Infectious Encephalitis
- Arbovirus Infections
- Vector Borne Diseases
- Encephalomyelitis
- Alphavirus Infections
- Togaviridae Infections
- Encephalitis
- Encephalomyelitis, Equine
- Encephalomyelitis, Eastern Equine
Other Study ID 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.
Clinical Trials on Eastern Equine Encephalitis
-
National Institute of Allergy and Infectious Diseases...CompletedAlphavirus Infections | Eastern Equine Encephalitis | Venezuelan Equine Encephalitis | Western Equine EncephalitisUnited States
-
U.S. Army Medical Research and Development CommandCompletedEastern Equine EncephalitisUnited States
-
Ichor Medical Systems IncorporatedUS Army Medical Research Institute of Infectious DiseasesCompletedVenezuelan Equine Encephalitis Virus InfectionUnited States
-
U.S. Army Medical Research and Development CommandUnknownWestern Equine EncephalitisUnited States
-
DynPort Vaccine Company LLC, A GDIT CompanyWithdrawnVenezuelan Equine EncephalitisUnited States
-
U.S. Army Medical Research and Development CommandActive, not recruitingVenezuelan Equine EncephalomyelitisUnited States
-
U.S. Army Medical Research and Development CommandCompleted
-
PharmaJet, Inc.United States Department of DefenseRecruiting
-
U.S. Army Medical Research and Development CommandUS Army Medical Research Institute of Infectious DiseasesActive, not recruitingVenezuelan Equine Encephalomyelitis Virus DiseaseUnited States
-
U.S. Army Medical Research and Development CommandActive, not recruitingVenezuelan Equine EncephalomyelitisUnited States
Clinical Trials on Eastern Equine Encephalitis Vaccine, Inactivated, Dried, TSI-GSD 104
-
U.S. Army Medical Research and Development CommandCompletedEastern Equine EncephalitisUnited States
-
U.S. Army Medical Research and Development CommandCompletedRift Valley FeverUnited States
-
U.S. Army Medical Research and Development CommandNot yet recruitingVenezuelan Equine EncephalomyelitisUnited States
-
Jiangsu Province Centers for Disease Control and...Shandong Hengye Biotech Co., Ltd.Completed