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

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00582504
First Posted: December 28, 2007
Last Update Posted: October 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]
  • Number of adverse events. [ Time Frame: 7 years ]

Secondary Outcome Measures:
  • Number of confirmed cases of VEE disease among vaccinated subjects who achieved a PRNT 80 ≥ 1:20. [ Time Frame: 7 years ]

Estimated Enrollment: 500
Actual Study Start Date: September 2007
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: November 2018 (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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00582504


Locations
United States, Maryland
U.S. Army Medical Research Institute of Infectious Diseases
Fort Deterick, Maryland, United States, 21702
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Ronald Reisler, MD USAMRIID Medical Division
  More Information

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 ( Other Identifier: IRB )
First Submitted: December 19, 2007
First Posted: December 28, 2007
Last Update Posted: October 13, 2017
Last Verified: October 2017

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

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