Safety and Immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine (VEE C-84) as a Booster to VEE TC-83 - 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:	NCT00582088

Purpose

The study is designed to assess the safety and immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI GSD 205, as a booster vaccination.

Condition	Intervention	Phase
Venezuelan Equine Encephalomyelitis	Biological: VEE C-84	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 Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI GSD 205 When Used as a Booster After TC-83 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 adverse events will be evaluated for all intent-to-treat subjects: headache, myalgia, fever, fatigue, sore throat, erythema, tenderness, and warmth. Immunogenicity: Measured by the 80% plaque-reduction neutralization titer (PRNT80). [ Time Frame: AEs recorded through 28 days after each booster dose; SAEs recorded for study duration; Immunogencity:PRNT80 at days 21 and 35 after each booster dose 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 confirmed cases of VEE disease among vaccinated subjects compliant with titer schedule with documented exposure 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:	January 2008
Estimated Study Completion Date:	January 2013
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Intervention Details:

Subjects will receive a 0.5 mL subcutaneous injection in the upper outer aspect of arm; maximum of four boosters in 1 year if titer <1:20.

Detailed Description:

Study Objectives:

Primary:

To assess safety of Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI GSD 205, as a booster vaccination as a single dose or a three-dose series, and To assess immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI GSD 205, as a booster vaccination as a single dose or a three-dose series

Secondary:

To assess incidence of VEE infection in C-84 boosted 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 < 1:20 before immunization.
(females) Negative urine 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 VEE virus (with up-to-date risk assessment).
Previous TC-83 vaccination
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.
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 C-84.
Any unresolved AEs resulting from a previous immunization.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00582088

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-14350, FY06-27
Study First Received:	December 19, 2007
Last Updated:	November 6, 2008
ClinicalTrials.gov Identifier:	NCT00582088
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