Safety and Immunogenicity Study of Eastern Equine Encephalitis (EEE) Vaccine - Full Text View

Sponsored by:	U.S. Army Medical Research and Materiel Command
Information provided by:	U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:	NCT00584805

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 II

MedlinePlus related topics: Encephalitis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

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:	February 2013
Estimated Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Detailed Description:

Study Objectives:

Primary:

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:	17 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

At least 18 years old, or if active military duty, 17 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00584805

Contacts

Contact: Ellen Boudreau	301-619-4639	ellen.boudreau@amedd.army.mil
Contact: Diane Ullman	301-619-4828	diane.ullman@amedd.army.mil

Locations

United States, Maryland
U.S. Army Medical Research Institute of Infectious Diseases	Recruiting
Fort Detrick, Maryland, United States, 21702
Contact: Ellen F Boudreau, MD 301-619-4639 ellen.boudreau@amedd.army.mil
Contact: Diane R Ullman, MS 301-619-4828 diane.ullman@amedd.army.mil

Sponsors and Collaborators

U.S. Army Medical Research and Materiel Command

Investigators

Principal Investigator:

Ellen F Boudreau, MD

USAMRIID Medical Division

More Information

Responsible Party:	USAMRMC, USAMMDA ( Robert E. Miller, PhD, Sponsor Representative, Director, Division of Regulated Activities and Compliance )
Study ID Numbers:	A-14568, FY06-31
Study First Received:	December 19, 2007
Last Updated:	November 6, 2008
ClinicalTrials.gov Identifier:	NCT00584805
Health Authority:	United States: Food and Drug Administration

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

Encephalitis, Viral Infections, Neurologic diseases, Alphavirus Infections, EEE

Study placed in the following topic categories:

Virus Diseases
Central Nervous System Infections
Encephalomyelitis, Equine
Central Nervous System Diseases
Encephalomyelitis
Healthy

Arbovirus Infections
Brain Diseases
Togaviridae Infections
Encephalitis
Encephalomyelitis, Eastern Equine

Additional relevant MeSH terms:

Encephalitis, Viral
RNA Virus Infections
Nervous System Diseases
Alphavirus Infections
Central Nervous System Viral Diseases

ClinicalTrials.gov processed this record on January 16, 2009