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
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:
  • 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 ]

Estimated Enrollment: 500
Study Start Date: February 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 19, 2007
Last Updated: March 6, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Encephalitis
Encephalomyelitis, Eastern Equine
Encephalomyelitis, Equine
Alphavirus Infections
Arbovirus Infections
Brain Diseases
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
Encephalitis, Viral
Encephalomyelitis
Nervous System Diseases
RNA Virus Infections
Togaviridae Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 29, 2014