Eastern Equine EncephalitisPhase 2NCT02654509

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

A Phase 2 study testing Eastern Equine Encephalitis Vaccine, Inactivated, Dried, TSI-GSD 104 in people with Eastern Equine Encephalitis, run by U.S. Army Medical Research and Development Command at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Eastern Equine Encephalitis
What is being tested?: Eastern Equine Encephalitis Vaccine, Inactivated, Dried, TSI-GSD 104
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 138 participants
Where: 1 siteUnited States
Study dates: 3 Jun 2008to 18 Mar 2018
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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:

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

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

Other trials in United States

About this study

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

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

Read the 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.

Conditions: Eastern Equine Encephalitis
Being tested: Eastern Equine Encephalitis Vaccine, Inactivated, Dried, TSI-GSD 104
Medical subject headings: Encephalomyelitis, Eastern Equine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Eastern Equine Encephalitis Vaccine, Inactivated, Dried, TSI-GSD 104Biological
Eastern Equine Encephalitis Vaccine, Inactivated, Dried

Study groups in NCT02654509
Study group	Role	What they receive
EEE vaccine	Experimental	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. Receives: Biological: Eastern Equine Encephalitis Vaccine, Inactivated, Dried, TSI-GSD 104

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 30 days
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.
Measured: 11-13 months
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.
Measured: 1-5 weeks

Secondary outcomes (4)

% vaccinated subjects with PRNT80 ≥ 1:40 after primary series.
measure immunogenicity is the 80% plaque-reduction neutralization titer (PRNT80).
Measured: 11-13 months
% vaccinated subjects with PRNT80 ≥ 1:40 after 6-month booster dose.
measure immunogenicity is the 80% plaque-reduction neutralization titer (PRNT80).
Measured: 6 months
% vaccinated subjects with PRNT80 ≥ 1:40 at 11-13 months after first primary dose.
measure immunogenicity is the 80% plaque-reduction neutralization titer (PRNT80).
Measured: 11-13 months
% 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).
Measured: 1-4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jun 200818 Mar 2018

First posted13 Jan 2016 (estimated)
Study start3 Jun 2008
Primary completion16 Feb 2016
Study completion18 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Eastern Equine EncephalitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 138 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02654509
Sponsor's protocol ID: A-14568.a
Status last verified: Mar 2020
First submitted: 11 Jan 2016
Last updated: 17 Mar 2020
Results posted: No
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02654509
Acronym / sponsor ID: A-14568.a
Conditions: Eastern Equine Encephalitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 138 participants (actual)
Lead sponsor: U.S. Army Medical Research and Development CommandUS federal agency
Study start: 3 Jun 2008 (actual)
Primary completion: 16 Feb 2016 (actual)
Study completion: 18 Mar 2018 (actual)
First posted: 13 Jan 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
EEE vaccine	Experimental	Biological: Eastern Equine Encephalitis Vaccine, Inactivated, Dried, TSI-GSD 104Eastern 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

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.

Key exclusion criteria (14 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Eastern Equine Encephalitis Vaccine, Inactivated, Dried, TSI-GSD 104Eastern Equine Encephalitis Vaccine, Inactivated, Dried	Biological	EEE vaccine

Primary outcome

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.
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.
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.

4 secondary outcomes

% vaccinated subjects with PRNT80 ≥ 1:40 after primary series.
Time frame: 11-13 months
% vaccinated subjects with PRNT80 ≥ 1:40 after 6-month booster dose.
Time frame: 6 months
% vaccinated subjects with PRNT80 ≥ 1:40 at 11-13 months after first primary dose.
Time frame: 11-13 months
% vaccinated subjects with PRNT80 ≥ 1:40 after week 1, 2, 3, or 4 booster doses.
Time frame: 1-4 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert Rivard, MD principal investigator

US Army Medical Research Institute of Infectious Diseases

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-Vaccination Adverse Events by System Organ Class and Severity (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02654509.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020; AzTrials last refreshed its copy on 6 Nov 2026.