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

This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command Identifier:
First received: December 19, 2007
Last updated: October 28, 2015
Last verified: October 2015
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 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:
  • Number of participants with a 80% plaque-reduction neutralization titer (PRNT80) [ Time Frame: 21-35 days, 42-56 days, 12-15 months ] [ Designated as safety issue: No ]
  • Number of adverse events. [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of confirmed cases of VEE disease among vaccinated subjects who achieved a PRNT 80 ≥ 1:20. [ Time Frame: 7 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: September 2007
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaccination
Biological: VEE TC-83
Subjects will receive a single 0.5 mL dose by subcutaneous route in the upper outer aspect of arm


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

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 identifier: NCT00582504

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
Principal Investigator: Robert Rivard, MD USAMRIID Medical Division
  More Information

No publications provided

Responsible Party: U.S. Army Medical Research and Materiel Command Identifier: NCT00582504     History of Changes
Other Study ID Numbers: A-14317, FY06-26
Study First Received: December 19, 2007
Last Updated: October 28, 2015
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Encephalomyelitis, Equine
Encephalomyelitis, Venezuelan Equine
Alphavirus Infections
Arbovirus Infections
Brain Diseases
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
Encephalitis, Viral
Nervous System Diseases
RNA Virus Infections
Togaviridae Infections
Virus Diseases processed this record on November 30, 2015