Suspended

VEE TC-83A 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

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What is being tested

VEE TC-83

Biological
Who is being recruted

Infectious Encephalitis+18

+ Vector Borne Diseases

+ Neuroinflammatory Diseases

From 18 to 65 Years
+20 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 2
Interventional
Study Start: September 2007
See protocol details

Summary

Principal SponsorU.S. Army Medical Research and Development Command
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2007

Actual date on which the first participant was enrolled.

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).

Official TitleA 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
NCT00582504
Principal SponsorU.S. Army Medical Research and Development Command
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

500 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Infectious EncephalitisVector Borne DiseasesNeuroinflammatory DiseasesMosquito-Borne DiseasesArbovirus InfectionsBrain DiseasesCentral Nervous System DiseasesCentral Nervous System InfectionsEncephalitisEncephalitis, ArbovirusEncephalomyelitisEncephalomyelitis, EquineEncephalomyelitis, Venezuelan EquineInfectionsNervous System DiseasesRNA Virus InfectionsTogaviridae InfectionsVirus DiseasesAlphavirus InfectionsEncephalitis, ViralCentral Nervous System Viral Diseases

Criteria

9 inclusion criteria required to participate
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
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11 exclusion criteria prevent from participating
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.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
VEE TC-83

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

U.S. Army Medical Research Institute of Infectious Diseases

Fort Deterick, United StatesOpen U.S. Army Medical Research Institute of Infectious Diseases in Google Maps
SuspendedOne Study Center