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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00584805
Recruitment Status : Completed
First Posted : January 2, 2008
Results First Posted : September 24, 2019
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
U.S. Army Medical Research and Development Command

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

Condition or disease Intervention/treatment Phase
Eastern Equine Encephalitis Biological: Inactivated, Dried, TSI-GSD 104, EEE Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : June 3, 2008
Actual Primary Completion Date : June 27, 2016
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Encephalitis

Arm Intervention/treatment
Experimental: Vaccination
Inactivated, Dried, TSI-GSD 104, EEE
Biological: Inactivated, Dried, TSI-GSD 104, EEE
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.
Other Name: EEE A-14568




Primary Outcome Measures :
  1. 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).


  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Secondary Outcome Measures :
  1. Number of Subject Experiencing Local and Systemic Adverse Events [ Time Frame: vaccination/booster days 0-28 for up to 5 years ]
    Number of subjects of who experienced and didn't experience local and systemic adverse events after vaccination and booster.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00584805


Locations
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United States, Maryland
U.S. Army Medical Research Institute of Infectious Diseases
Fort Deterick, Maryland, United States, 21702
Sponsors and Collaborators
U.S. Army Medical Research and Development Command
Investigators
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Principal Investigator: Robert Rivard, MD USAMRIID Medical Division
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Responsible Party: U.S. Army Medical Research and Development Command
ClinicalTrials.gov Identifier: NCT00584805    
Other Study ID Numbers: A-14568
FY06-31 ( Other Identifier: SIP )
S-09-12 ( Other Identifier: Sponsor number )
First Posted: January 2, 2008    Key Record Dates
Results First Posted: September 24, 2019
Last Update Posted: September 24, 2019
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by U.S. Army Medical Research and Development Command:
EEE
Additional relevant MeSH terms:
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Encephalomyelitis, Equine
Encephalomyelitis, Eastern Equine
Encephalitis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arbovirus Infections
Virus Diseases
Encephalitis, Viral
Central Nervous System Viral Diseases
Alphavirus Infections
Togaviridae Infections
RNA Virus Infections
Infectious Encephalitis
Central Nervous System Infections
Encephalomyelitis