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

Primary Purpose

Venezuelan Equine Encephalomyelitis

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VEE TC-83
Sponsored by
U.S. Army Medical Research and Development Command
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venezuelan Equine Encephalomyelitis focused on measuring Encephalitis,VEE

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • U.S. Army Medical Research Institute of Infectious Diseases

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vaccination

Arm Description

VEE TC-83

Outcomes

Primary Outcome Measures

Number of participants with a 80% plaque-reduction neutralization titer (PRNT80)
Number of adverse events.

Secondary Outcome Measures

Number of confirmed cases of VEE disease among vaccinated subjects who achieved a PRNT 80 ≥ 1:20.

Full Information

First Posted
December 19, 2007
Last Updated
February 10, 2021
Sponsor
U.S. Army Medical Research and Development Command
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1. Study Identification

Unique Protocol Identification Number
NCT00582504
Brief Title
Safety and Immunogenicity Study of the Venezuelan Equine Encephalomyelitis Vaccine
Acronym
VEE TC-83
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 2007 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
U.S. Army Medical Research and Development Command

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venezuelan Equine Encephalomyelitis
Keywords
Encephalitis,VEE

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vaccination
Arm Type
Experimental
Arm Description
VEE TC-83
Intervention Type
Biological
Intervention Name(s)
VEE TC-83
Intervention Description
Subjects will receive a single 0.5 mL dose by subcutaneous route in the upper outer aspect of arm
Primary Outcome Measure Information:
Title
Number of participants with a 80% plaque-reduction neutralization titer (PRNT80)
Time Frame
21-35 days, 42-56 days, 12-15 months
Title
Number of adverse events.
Time Frame
7 years
Secondary Outcome Measure Information:
Title
Number of confirmed cases of VEE disease among vaccinated subjects who achieved a PRNT 80 ≥ 1:20.
Time Frame
7 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Reisler, MD
Organizational Affiliation
USAMRIID Medical Division
Official's Role
Principal Investigator
Facility Information:
Facility Name
U.S. Army Medical Research Institute of Infectious Diseases
City
Fort Deterick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States

12. IPD Sharing Statement

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Safety and Immunogenicity Study of the Venezuelan Equine Encephalomyelitis Vaccine

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