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

February 10, 2021 updated by: U.S. Army Medical Research and Development Command

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Fort Deterick, Maryland, United States, 21702
        • U.S. Army Medical Research Institute of Infectious Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with a 80% plaque-reduction neutralization titer (PRNT80)
Time Frame: 21-35 days, 42-56 days, 12-15 months
21-35 days, 42-56 days, 12-15 months
Number of adverse events.
Time Frame: 7 years
7 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

U.S. Army Medical Research and Development Command

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2007

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

December 19, 2007

First Submitted That Met QC Criteria

December 27, 2007

First Posted (Estimate)

December 28, 2007

Study Record Updates

Last Update Posted (Actual)

February 11, 2021

Last Update Submitted That Met QC Criteria

February 10, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-14317
  • FY06-26 (Other Identifier: IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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