Safety and Immunogenicity Study of the Venezuelan Equine Encephalomyelitis Vaccine

Study Overview
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Brief Summary
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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 Title
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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

Conditions
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Venezuelan Equine Encephalomyelitis

Intervention / Treatment
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* Biological: VEE TC-83


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaccination<br>VEE TC-83 | Biological: VEE TC-83<br>* Subjects will receive a single 0.5 mL dose by subcutaneous route in the upper outer aspect of arm<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Encephalitis,VEE