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Virus Therapy

VEE Vaccine for Venezuelan Equine Encephalomyelitis (VEE Trial)

Phase 2
Waitlist Available
Led By Anthony P Cardile, DO, MAJ
Research Sponsored by U.S. Army Medical Research and Development Command
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be 18 to 65 years old at time of consent
Have received VEE TC-83 vaccine
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 12-15
Awards & highlights

VEE Trial Summary

This trial is testing a vaccine for Venezuelan Equine Encephalitis (VEE) to see if it is safe and effective. The goal is to also collect data on how well the vaccine works in preventing VEE infection in people who are exposed to the virus through their job.

Who is the study for?
Adults aged 18-65 at risk of Venezuelan Equine Encephalomyelitis exposure, with a medical history and lab tests on file. Women must not be pregnant or plan pregnancy within 3 months post-vaccination. Participants must report adverse events for at least 28 days after vaccination and cannot have had certain previous VEE vaccines or specific allergies.Check my eligibility
What is being tested?
The trial is testing the safety and immune response to an inactivated VEE vaccine (C-84, TSI-GSD 205) as a booster in adults who've previously received the TC-83 vaccine. It also tracks occupational infection rates among vaccinated individuals.See study design
What are the potential side effects?
Potential side effects may include reactions related to components of the vaccine such as Neomycin sulfate, Streptomycin, Formaldehyde, Eggs, Human serum albumin, Guinea pig heart cells, Sodium bisulfite.

VEE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I have received the VEE TC-83 vaccine.

VEE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 12-15
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 12-15 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Subjects Who Develop titers of >1:20
Secondary outcome measures
GMT for PRNT80 Titers of Subjects at Each Scheduled Time Point
Percentage of Subjects with Adverse Events (AEs) Following Vaccination
Percentage of Subjects with Each AE Type (local or systemic)

VEE Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort B: Responders to TC-83 or previous C-84 vaccinationsExperimental Treatment1 Intervention
Subjects who showed an initial immune response ≥ 1:20 to TC-83 and whose titer decreased over time or who rollover from a previous VEE C-84 protocol will receive a single 0.5 mL booster dose of C-84 vaccine. Subjects who were initial non-responders (< 1:20) to TC-83 will be given subcutaneous 0.5 mL injections on Days 0, 28-35, and 56-63
Group II: Cohort A: Initial Non-responders to VEE TC-83 vaccinationsExperimental Treatment1 Intervention
Venezuelan Equine Encephalomyelitis (VEE) Vaccine, Inactivated, Dried, C-84, TSI-GSD 205, Lot 7, Run 1, to be administered as dose(s) of 0.5 mL given subcutaneously in the upper outer aspect of the triceps area.

Find a Location

Who is running the clinical trial?

U.S. Army Medical Research and Development CommandLead Sponsor
287 Previous Clinical Trials
245,409 Total Patients Enrolled
Anthony P Cardile, DO, MAJPrincipal InvestigatorUSAMRIID

Media Library

VEE Vaccine (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03531242 — Phase 2
Venezuelan Equine Encephalomyelitis Research Study Groups: Cohort B: Responders to TC-83 or previous C-84 vaccinations, Cohort A: Initial Non-responders to VEE TC-83 vaccinations
Venezuelan Equine Encephalomyelitis Clinical Trial 2023: VEE Vaccine Highlights & Side Effects. Trial Name: NCT03531242 — Phase 2
VEE Vaccine (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03531242 — Phase 2
~125 spots leftby Jun 2025
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