Safety and Immunogenicity Study of the Venezuelan Equine Encephalomyelitis Vaccine

Venezuelan Equine Encephalomyelitis Clinical Trial

— VEE TC-83  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00582504
• Other study ID #: A-14317
• Secondary ID: FY06-26
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 2007
• Est. completion date: June 2022

Study information

• Verified date: February 2021
• Source: U.S. Army Medical Research and Development Command
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: June 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Encephalomyelitis
• Encephalomyelitis, Equine
• Encephalomyelitis, Venezuelan Equine
• Venezuelan Equine Encephalomyelitis

Intervention

Biological:
• VEE TC-83
Subjects will receive a single 0.5 mL dose by subcutaneous route in the upper outer aspect of arm

Locations

Country	Name	City	State
United States	U.S. Army Medical Research Institute of Infectious Diseases	Fort Deterick	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
U.S. Army Medical Research and Development Command

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with a 80% plaque-reduction neutralization titer (PRNT80)		21-35 days, 42-56 days, 12-15 months
Primary	Number of adverse events.		7 years
Secondary	Number of confirmed cases of VEE disease among vaccinated subjects who achieved a PRNT 80 = 1:20.		7 years