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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00584805
First Posted: January 2, 2008
Last Update Posted: March 29, 2017
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.
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
  Purpose
This study is designed to determine the safety and immunogenicity of Eastern Equine Encephalitis (EEE) Vaccine.

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by U.S. Army Medical Research and Materiel Command:

Primary Outcome Measures:
  • PRNT80 ≥ 1:40 after primary series [ Time Frame: 3 weeks and 8 weeks ]
  • PRNT80 ≥ 1:40 after 6-month booster dose [ Time Frame: 6 months ]
  • PRNT80 ≥ 1:40 at 11-13 months after the first primary dose [ Time Frame: 11-13 months ]
  • PRNT80 ≥ 1:40 after 1, 2, 3, or 4 booster doses [ Time Frame: Up to 5 years ]

Secondary Outcome Measures:
  • Number and frequency of local and systemic adverse events [ Time Frame: 5 years ]

Estimated Enrollment: 500
Actual Study Start Date: February 2008
Estimated Study Completion Date: December 2017
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (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.
  Contacts and Locations
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
United States, Maryland
U.S. Army Medical Research Institute of Infectious Diseases
Fort Detrick, Maryland, United States, 21702
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Robert Rivard, MD USAMRIID Medical Division
  More Information

Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT00584805     History of Changes
Other Study ID Numbers: A-14568
FY06-31 ( Other Identifier: SIP )
First Submitted: December 19, 2007
First Posted: January 2, 2008
Last Update Posted: March 29, 2017
Last Verified: March 2017

Keywords provided by U.S. Army Medical Research and Materiel Command:
EEE

Additional relevant MeSH terms:
Encephalitis
Encephalomyelitis, Equine
Encephalomyelitis, Eastern Equine
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