Safety and Immunogenicity Study of the Venezuelan Equine Encephalomyelitis 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:	NCT00582504

Purpose

This study is designed to determine safety of and immune response to Venezuelan Equine Encephalomyelitis Vaccine, Live, Attenuated, Dried TC-83, NDBR-102 (TC-83).

Condition	Intervention	Phase
Venezuelan Equine Encephalomyelitis	Biological: VEE TC-83	Phase II

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 a Single Dose of Venezuelan Equine Encephalomyelitis Vaccine, Live, Attenuated, Dried, TC-83, NDBR-102, as Primary Immunization in Healthy Adults At Risk for Exposure to Virulent Venezuelan Equine Encephalomyelitis Virus

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

Primary Outcome Measures:

Safety: Frequency of adverse events for all intent-to-treat subjects with headache, myalgia, fever, malaise, chills, fatigue, sore throat, nausea, and vomiting; Immunogenicity: Response as measured by 80% plaque reduction neutralization titer (PRNT80) [ Time Frame: Safety: AE's:28 days after immunization; SAE's:duration of study; Immunogenicity: PRNT80 at days 28, 56 and 12-15 months after vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety: Frequency of all other adverse events for all intent-to-treat subjects; Immunogenicity: Frequency of VEE disease among vaccinated subjects with documented exposure or with temperature (>100.5 degrees F)after working with VEE virus [ Time Frame: Safety: AE's: 28 days after vaccination; SAE's: duration of study; Immunogenicity: duration of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	500
Study Start Date:	September 2007
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Intervention Details:

Subjects will receive a single 0.5 mL dose by subcutaneous route in the upper outer aspect of arm

Detailed Description:

Study Objectives:

Primary:

To assess the safety of Venezuelan Equine Encephalomyelitis Vaccine, Live, Attenuated, Dried, TC-83, NDBR-102, as a single, primary immunization
To assess the immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine, Live, Attenuated, Dried, TC-83, NDBR-102, as a single, primary immunization, and

Secondary: To assess incidence of VEE infection in TC-83 vaccinated personnel.

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.
VEE PRNT80 < 1:10 before immunization.
(females) Negative serum pregnancy test on same day before vaccination. Not planning pregnancy for 3 months.
Actively enrolled in the SIP
At risk for exposure to virulent VEE 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 event (AE) up to 28 days after vaccination.

Exclusion Criteria:

Over age of 65 years.
Clinically significant abnormal lab results including evidence of Hepatitis C, Hepatitis B carrier state, or elevated liver function tests.
History of immunodeficiency or current treatment with immunosuppressive medication.
(females) Currently breastfeeding.
Confirmed human immunodeficiency virus (HIV) titer.
Family history (first degree relative, but not elderly parent with late onset) diabetes, personal history gestational diabetes, or confirmed elevated fasting serum glucose (> 125 mg/dL).
Serious allergic reaction to guinea pigs/guinea pig products.
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 and or exposure to another alphavirus).
Administration of any vaccine within 28 days of TC-83.
Any unresolved AEs resulting from a previous immunization.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00582504

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

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-14317, FY06-26
Study First Received:	December 19, 2007
Last Updated:	November 6, 2008
ClinicalTrials.gov Identifier:	NCT00582504
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, VEE

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
Encephalomyelitis, Venezuelan Equine
Togaviridae Infections
Encephalitis

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