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Virus Therapy

VEE Vaccine for Venezuelan Equine Encephalomyelitis (VEE Trial)

Q: If a patient is not yet 80 years old, can they still qualify for this research?

Eligibility for this study requires that potential patients are aged 18 to 65. If you are either under or over the specified age, there is 1 and 9 other studies you might be able to enroll in respectively.

Q: What are the potential risks associated with 0.5 mL Inactivated, Dried, C-84, TSI-GSD 205, Lot 7, Run 1?

Since Phase 2 trials only assess a medication's safety and not efficacy, our team at Power has given 0.5 mL Inactivated, Dried, C-84, TSI-GSD 205, Lot 7, Run 1 a score of 2.

Q: Are there any slots left for people who want to participate in this experiment?

According to the listing on clinicaltrials.gov, this study is not presently looking for new patients. The trial was first announced on June 1st 2021 and received its most recent update February 10th 2021. There are 13 other trials that are currently recruiting patients.

Q: Are there any prerequisites for participating in this clinical trial?

This study needs 500 individuals who have contracted encephalomyelitis, venezuelan equine and meet the following additional conditions: Be 18 to 65 years old at time of consent, considered at risk for exposure to VEE virus and who have submitted a Request for IND Vaccines for VDD <a href="https://www.withpower.com/clinical-trials/vaccine">vaccine</a>.

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

Select...

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 12-15

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

U.S. Army Medical Research and Development CommandLead Sponsor

285 Previous Clinical Trials

244,659 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

If a patient is not yet 80 years old, can they still qualify for this research?

"Eligibility for this study requires that potential patients are aged 18 to 65. If you are either under or over the specified age, there is 1 and 9 other studies you might be able to enroll in respectively."

Answered by AI

What are the potential risks associated with 0.5 mL Inactivated, Dried, C-84, TSI-GSD 205, Lot 7, Run 1?

"Since Phase 2 trials only assess a medication's safety and not efficacy, our team at Power has given 0.5 mL Inactivated, Dried, C-84, TSI-GSD 205, Lot 7, Run 1 a score of 2."

Answered by AI

Are there any slots left for people who want to participate in this experiment?

"According to the listing on clinicaltrials.gov, this study is not presently looking for new patients. The trial was first announced on June 1st 2021 and received its most recent update February 10th 2021. There are 13 other trials that are currently recruiting patients."

Answered by AI

Are there any prerequisites for participating in this clinical trial?

"This study needs 500 individuals who have contracted encephalomyelitis, venezuelan equine and meet the following additional conditions: Be 18 to 65 years old at time of consent, considered at risk for exposure to VEE virus and who have submitted a Request for IND Vaccines for VDD vaccine."

Answered by AI

Recent research and studies

Frontiers in Cellular and Infection MicrobiologyJournal

Developing Recombinant Antibodies by Phage Display Against Infectious Diseases and Toxins for Diagnostics and Therapy

Roth, Kristian Daniel Ralph, Esther Veronika Wenzel, Maximilian Ruschig, Stephan Steinke, Nora Langreder, Philip Alexander Heine, Kai-Thomas Schneider, et al.. 2021. “Developing Recombinant Antibodies by Phage Display Against Infectious Diseases and Toxins for Diagnostics and Therapy”. Frontiers in Cellular and Infection Microbiology. Frontiers Media SA. doi:10.3389/fcimb.2021.697876.

American Journal of EpidemiologyJournal

Venezuelan Equine Encephalomyelitis: Surveys of Human Illness During an Epizootic in Guatemala and El Salvador12

HINMAN, ALAN R., JOHN E. MCGOWAN JR., and BRIAN E. HENDERSON. 1971. “Venezuelan Equine Encephalomyelitis: Surveys of Human Illness During an Epizootic in Guatemala and El Salvador12”. American Journal of Epidemiology. Oxford University Press (OUP). doi:10.1093/oxfordjournals.aje.a121233.

VaccineJournal

Long-term Duration of Detectable Neutralizing Antibodies After Administration of Live-attenuated VEE Vaccine and Following Booster Vaccination with Inactivated VEE Vaccine

Pittman, Phillip R., Richard S. Makuch, Joseph A. Mangiafico, Timothy L. Cannon, Paul H. Gibbs, and Clarence J. Peters. 1996. “Long-term Duration of Detectable Neutralizing Antibodies After Administration of Live-attenuated VEE Vaccine and Following Booster Vaccination with Inactivated VEE Vaccine”. Vaccine. Elsevier BV. doi:10.1016/0264-410x(95)00168-z.

American Journal of EpidemiologyJournal