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

Primary Purpose

Eastern Equine Encephalitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Inactivated, Dried, TSI-GSD 104, EEE
Sponsored by
U.S. Army Medical Research and Development Command
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Eastern Equine Encephalitis focused on measuring EEE

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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).
  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Sites / Locations

  • U.S. Army Medical Research Institute of Infectious Diseases

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vaccination

Arm Description

Inactivated, Dried, TSI-GSD 104, EEE

Outcomes

Primary Outcome Measures

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).
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 19, 2007
Last Updated
September 20, 2019
Sponsor
U.S. Army Medical Research and Development Command
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1. Study Identification

Unique Protocol Identification Number
NCT00584805
Brief Title
Safety and Immunogenicity Study of Eastern Equine Encephalitis (EEE) Vaccine
Acronym
EEE
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
June 3, 2008 (Actual)
Primary Completion Date
June 27, 2016 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
U.S. Army Medical Research and Development Command

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eastern Equine Encephalitis
Keywords
EEE

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
Vaccination
Arm Type
Experimental
Arm Description
Inactivated, Dried, TSI-GSD 104, EEE
Intervention Type
Biological
Intervention Name(s)
Inactivated, Dried, TSI-GSD 104, EEE
Other Intervention Name(s)
EEE A-14568
Intervention Description
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.
Primary Outcome Measure Information:
Title
Subject Response Rates for PRNT80 Titers
Description
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).
Time Frame
5 years
Title
Response Rates of Post Dose 2: Day 21-35 PRNT80 Titers
Description
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.
Time Frame
Post dose 2, days 21-35
Title
Response Rates of Pre-Month 6 PRNT80 Titers
Description
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.
Time Frame
Pre-month 6
Title
Response Rates of Post Month 6: Day 21-35 PRNT80 Titers
Description
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.
Time Frame
Post month 6, days 21-35
Title
Response Rates of Post Booster 1: Day 21-35 PRNT80 Titers
Description
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.
Time Frame
Post booster 1, days 21-35
Title
Response Rates of Annual (11-13 Months) PRNT80 Titers
Description
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.
Time Frame
Months 11-13
Secondary Outcome Measure Information:
Title
Number of Subject Experiencing Local and Systemic Adverse Events
Description
Number of subjects of who experienced and didn't experience local and systemic adverse events after vaccination and booster.
Time Frame
vaccination/booster days 0-28 for up to 5 years

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: 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). 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. Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Rivard, MD
Organizational Affiliation
USAMRIID Medical Division
Official's Role
Principal Investigator
Facility Information:
Facility Name
U.S. Army Medical Research Institute of Infectious Diseases
City
Fort Deterick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33899755
Citation
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.
Results Reference
derived

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

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