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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT00584805
First received: December 19, 2007
Last updated: March 6, 2014
Last verified: March 2014

December 19, 2007
March 6, 2014
February 2008
June 2014   (final data collection date for primary outcome measure)
Safety: The frequency of adverse events in this EEE vaccine study will be evaluated for all intent-to-treat subjects; Immunogenicity: Measurement is the 80% plaque-reduction neutralization titer (PRNT80). [ Time Frame: AEs recorded through day 28 after each dose; SAEs recorded through duration of study; Immunogenicity: PRNT80 will be assessed after primary series and booster dose; Any EEE illness in a vaccinated subject will be recorded for duration of study. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00584805 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Safety and Immunogenicity Study of Eastern Equine Encephalitis (EEE) Vaccine
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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Eastern Equine Encephalitis
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
Experimental: Vaccination
Inactivated, Dried, TSI-GSD 104, EEE
Intervention: Biological: Inactivated, Dried, TSI-GSD 104, EEE
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
500
December 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • At least 18 years old.
  • EEE PRNT80 ≤ 1:20.
  • (females) Negative pregnancy test on the same day before vaccination.
  • Not planning pregnancy for 3 months.
  • Actively enrolled in the SIP.
  • 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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00584805
A-14568, FY06-31
No
U.S. Army Medical Research and Materiel Command
U.S. Army Medical Research and Materiel Command
Not Provided
Principal Investigator: Robert Rivard, MD USAMRIID Medical Division
U.S. Army Medical Research and Materiel Command
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP