Eastern Equine EncephalitisPhase 2EEENCT00584805

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

A Phase 2 study testing Inactivated, Dried, TSI-GSD 104, EEE 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 designed to determine the safety and immunogenicity of 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?: Inactivated, Dried, TSI-GSD 104, EEE
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 Jun 2017
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

At least 18 years old.
EEE PRNT80 ≤ 1:20.
EEE PRNT80 ≤ 1:40 for booster series
(females) Negative pregnancy test on the same day before vaccination.
Not planning pregnancy for 3 months.
At risk for exposure to virulent EEE virus (with up-to-date risk assessment).

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Up-to-date (within 1 year) physical examination/tests.
Sign and date the approved informed consent.
Willing to return for all follow-up visits.
Agree to report adverse events (AE) up to 28 days after each vaccination.

Who cannot join

Over 65 years of age (for Primary Immunization).
Clinically significant abnormal lab results including evidence of Hepatitis C, Hepatitis B carrier state, or elevated (2X normal) liver function tests.
History of immunodeficiency or current treatment with immunosuppressive medication.
(females) Currently breastfeeding.
Confirmed human immunodeficiency virus (HIV) titer.
Any known allergies to components of the vaccine.

Show all 9Show fewer

A medical condition that, in the judgment of the Principal Investigator (PI), would impact subject safety (i.e.-vaccination or exposure to another Alphavirus).
Administration of any IND product or live vaccine within 28 days of EEE.
Any unresolved AEs resulting from a previous immunization.

Trial locations and contacts

1 site in 1 country.

United States1 site

U.S. Army Medical Research Institute of Infectious Diseases
Fort Deterick, Maryland, 21702

Other trials in United States

About this study

Official title: A Multi-Site Phase 2 Open-Label, Safety and Immunogenicity Study of Eastern Equine Encephalitis Vaccine, Inactivated, Dried, TSI-GSD 104 in Healthy Adults At Risk for Exposure to Eastern Equine Encephalitis Virus

This study is designed to determine the safety and immunogenicity of Eastern Equine Encephalitis (EEE) Vaccine.

Read the detailed description

This was an open-label, vaccine study of Eastern Equine Encephalitis Vaccine, Inactivated Dried, EEE, TSI-GSD 104 in healthy, adult subjects. No concurrent control group was used. The controls used in this study to assess immunogenicity were historical PRNT80 values obtained in past studies of the EEE vaccine. Rates of adverse events (AEs) were tabulated by relationship to product administration and severity.

The primary objectives are to assess the safety of Eastern Equine Encephalitis Vaccine, Inactivated, Dried EEE, TSI GSD 104, and to assess immunogenicity of Eastern Equine Encephalitis Vaccine, Inactivated, Dried EEE, TSI GSD 104.

Conditions: Eastern Equine Encephalitis
Being tested: Inactivated, Dried, TSI-GSD 104, EEE
Keywords: EEE
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.

Inactivated, Dried, TSI-GSD 104, EEEBiological
Also called EEE A-14568
Subjects will receive 0.5ml SQ, as a two-dose primary series (days 0 and 28) and 0.1ml, as a mandatory booster dose at 6 months. A booster dose may be administered before 6 months if PRNT80 is < 1:40 after day 28. Up to four booster doses may be given in any 1-year period.

Study groups in NCT00584805
Study group	Role	What they receive
Vaccination	Experimental	Inactivated, Dried, TSI-GSD 104, EEE Receives: Biological: Inactivated, Dried, TSI-GSD 104, EEE

What is being measured

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

Subject Response Rates for PRNT80 Titers
Subject response rates for PRNT80 titers for vaccinations and all boosters. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population.
Four to 5 weeks for primary vaccinations (3) and up to four boost doses in 1 year period for a total duration of up to 5 years (anticipated duration of study execution).
Measured: 5 years
Response Rates of Post Dose 2: Day 21-35 PRNT80 Titers
Subject response rates for PRNT80 titers for post dose 2, days 21-35. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population.
Measured: Post dose 2, days 21-35
Response Rates of Pre-Month 6 PRNT80 Titers
Subject response rates for PRNT80 titers of pre-month 6. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population.
Measured: Pre-month 6
Response Rates of Post Month 6: Day 21-35 PRNT80 Titers
Subject response rates for PRNT80 titers for post month 6, days 21-35. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population.
Measured: Post month 6, days 21-35
Response Rates of Post Booster 1: Day 21-35 PRNT80 Titers
Subject response rates for PRNT80 titers for post booster 1, days 21-35. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population.
Measured: Post booster 1, days 21-35
Response Rates of Annual (11-13 Months) PRNT80 Titers
Subject annual response rates for PRNT80 titers for months 11-13. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population.
Measured: Months 11-13

Secondary outcomes (1)

Number of Subject Experiencing Local and Systemic Adverse Events
Number of subjects of who experienced and didn't experience local and systemic adverse events after vaccination and booster.
Measured: vaccination/booster days 0-28 for up to 5 years

Timeline

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

3 Jun 2008Jun 2017

First posted2 Jan 2008 (estimated)
Study start3 Jun 2008
Primary completion27 Jun 2016
Study completionJun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
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: NCT00584805
Sponsor's protocol ID: A-14568
Other IDs: FY06-31, S-09-12
Acronym: EEE
Status last verified: Oct 2018
First submitted: 19 Dec 2007
Last updated: 24 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Schultz JS, Sparks H, Beckham JD. Arboviral central nervous system infections. Curr Opin Infect Dis. 2021 Jun 1;34(3):264-271. doi: 10.1097/QCO.0000000000000729.
PubMed 33899755

Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Site Phase 2 Open-Label, Safety and Immunogenicity Study of Eastern Equine Encephalitis Vaccine, Inactivated, Dried, TSI-GSD 104 in Healthy Adults At Risk for Exposure to Eastern Equine Encephalitis Virus
ClinicalTrials.gov ID: NCT00584805
Acronym / sponsor ID: EEE / A-14568
Conditions: Eastern Equine Encephalitis
Keywords: EEE
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: 27 Jun 2016 (actual)
Study completion: Jun 2017 (actual)
First posted: 2 Jan 2008 (estimated)
Results: Posted 24 Sep 2019

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 designed to determine the safety and immunogenicity of 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
Vaccination	Experimental	Biological: Inactivated, Dried, TSI-GSD 104, EEEInactivated, Dried, TSI-GSD 104, EEE

Who may qualify

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

Key inclusion criteria (10 listed)

At least 18 years old.
EEE PRNT80 ≤ 1:20.
EEE PRNT80 ≤ 1:40 for booster series
(females) Negative pregnancy test on the same day before vaccination.
Not planning pregnancy for 3 months.

Key exclusion criteria (9 listed)

Over 65 years of age (for Primary Immunization).
Clinically significant abnormal lab results including evidence of Hepatitis C, Hepatitis B carrier state, or elevated (2X normal) liver function tests.
History of immunodeficiency or current treatment with immunosuppressive medication.
(females) Currently breastfeeding.
Confirmed human immunodeficiency virus (HIV) titer.

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
Inactivated, Dried, TSI-GSD 104, EEEAlso: EEE A-14568Subjects will receive 0.5ml SQ, as a two-dose primary series (days 0 and 28) and 0.1ml, as a mandatory booster dose at 6 months. A booster dose may be administered before 6 months if PRNT80 is < 1:40 after day 28. Up to four booster doses may be given in any 1-year period.	Biological	Vaccination

Primary outcome

Subject Response Rates for PRNT80 Titers
Time frame: 5 years
Subject response rates for PRNT80 titers for vaccinations and all boosters. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population. Four to 5 weeks for primary vaccinations (3) and up to four boost doses in 1 year period for a total duration of up to 5 years (anticipated duration of study execution).
Response Rates of Post Dose 2: Day 21-35 PRNT80 Titers
Time frame: Post dose 2, days 21-35
Subject response rates for PRNT80 titers for post dose 2, days 21-35. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population.
Response Rates of Pre-Month 6 PRNT80 Titers
Time frame: Pre-month 6
Subject response rates for PRNT80 titers of pre-month 6. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population.
Response Rates of Post Month 6: Day 21-35 PRNT80 Titers
Time frame: Post month 6, days 21-35
Subject response rates for PRNT80 titers for post month 6, days 21-35. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population.
Response Rates of Post Booster 1: Day 21-35 PRNT80 Titers
Time frame: Post booster 1, days 21-35
Subject response rates for PRNT80 titers for post booster 1, days 21-35. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population.
Response Rates of Annual (11-13 Months) PRNT80 Titers
Time frame: Months 11-13
Subject annual response rates for PRNT80 titers for months 11-13. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population.

1 secondary outcome

Number of Subject Experiencing Local and Systemic Adverse Events
Time frame: vaccination/booster days 0-28 for up to 5 years

Results and safety

Results posted to the registry on 24 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vaccination	138	39

Primary outcome: Subject Response Rates for PRNT80 Titers

Time frame: 5 years. Count of participants. Unit: Participants

Measure	Vaccination n = 138
Post dose 2: Day 21-35	39
Pre-month 6	28
Post month 6, Day 21-35	48
Post booster 1, Day 21-35	79
Post booster 2, Day 21-35	24
Post booster 3, Day 21-35	9
Post booster 4, Day 21-35	7
Post booster 5, Day 21-35	3

Population analysed: Only observations or specimens collected according to the protocol were included in the analyses

Primary outcome: Response Rates of Post Dose 2: Day 21-35 PRNT80 Titers

Time frame: Post dose 2, days 21-35. Count of participants. Unit: Participants

Measure	Vaccination n = 138
Responders: Year: 2008	8
Responders: Year: 2009	4
Responders: Year: 2010	10
Responders: Year: 2011	12
Responders: Year: 2013	5
Responders: Year: 2014	2
Non-responders: Year: 2008	14
Non-responders: Year: 2009	6

Population analysed: Only observations or specimens collected according to the protocol were included in the analyses

Primary outcome: Response Rates of Pre-Month 6 PRNT80 Titers

Time frame: Pre-month 6. Count of participants. Unit: Participants

Measure	Vaccination n = 138
Responders: Year: 2008	7
Responders: Year: 2009	3
Responders: Year: 2010	8
Responders: Year: 2011	6
Responders: Year: 2013	3
Responders: Year: 2014	1
Non-responders: Year: 2008	13
Non-responders: Year: 2009	6

Population analysed: Only observations or specimens collected according to the protocol were included in the analyses

Primary outcome: Response Rates of Post Month 6: Day 21-35 PRNT80 Titers

Time frame: Post month 6, days 21-35. Count of participants. Unit: Participants

Measure	Vaccination n = 138
Responders: Year: 2008	2
Responders: Year: 2009	16
Responders: Year: 2010	9
Responders: Year: 2011	11
Responders: Year: 2012	2
Responders: Year: 2013	1
Responders: Year: 2014	6
Responders: Year: 2015	2

Population analysed: Only observations or specimens collected according to the protocol were included in the analyses

1 secondary outcome is reported in the full results.

Adverse events

Time frame: vaccination and booster days 0-28 for up to 5 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vaccination/Booster	5 of 136 (3.7%)	73 of 136 (53.7%)	0 of 136

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33899755Schultz JS, Sparks H, Beckham JD. Arboviral central nervous system infections. Curr Opin Infect Dis. 2021 Jun 1;34(3):264-271. doi: 10.1097/QCO.0000000000000729.

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

USAMRIID Medical Division

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

Questions about this trial

What is this clinical trial studying?

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

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 10 inclusion and 9 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 24 Sep 2019. 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?

Yes. Results are posted in the registry (first posted 24 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Subject Response Rates for PRNT80 Titers (time frame: 5 years). The study lists 6 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 NCT00584805, which also lists 1 linked publication.

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 24 Sep 2019.