Safety and Immunogenicity Study of the Venezuelan Equine Encephalomyelitis Vaccine (VEE TC-83)

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:
NCT00582504
First received: December 19, 2007
Last updated: March 6, 2014
Last verified: March 2014
  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 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 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

Resource links provided by NLM:


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: February 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaccination
VEE TC-83
Biological: VEE TC-83
Subjects will receive a single 0.5 mL dose by subcutaneous route in the upper outer aspect of arm

Detailed Description:

Study Objectives:

Primary:

  1. To assess the safety of Venezuelan Equine Encephalomyelitis Vaccine, Live, Attenuated, Dried, TC-83, NDBR-102, as a single, primary immunization
  2. 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:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least 18 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
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: NCT00582504

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: Mark Goldberg, MD USAMRIID Medical Division
  More Information

No publications provided

Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT00582504     History of Changes
Other Study ID Numbers: A-14317, FY06-26
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:
Encephalitis,VEE

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

ClinicalTrials.gov processed this record on July 26, 2014