Safety and Immunogenicity Study of the Venezuelan Equine Encephalomyelitis Vaccine

NCT ID: NCT00582504

Last Updated: 2021-02-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2022-06-30

Brief 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).

Conditions

Venezuelan Equine Encephalomyelitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Vaccination

VEE TC-83

Group Type: EXPERIMENTAL

VEE TC-83

Intervention Type: BIOLOGICAL

Subjects will receive a single 0.5 mL dose by subcutaneous route in the upper outer aspect of arm

Interventions

VEE TC-83

Subjects will receive a single 0.5 mL dose by subcutaneous route in the upper outer aspect of arm

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

U.S. Army Medical Research and Development Command

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald Reisler, MD

Role: PRINCIPAL_INVESTIGATOR

USAMRIID Medical Division

Locations

U.S. Army Medical Research Institute of Infectious Diseases

Fort Deterick, Maryland, United States

Countries

United States

Other Identifiers

FY06-26

Identifier Type: OTHER

Identifier Source: secondary_id

A-14317

Identifier Type: -

Identifier Source: org_study_id