Safety and Immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine (VEE C-84) as a Booster to VEE TC-83

NCT ID: NCT00582088

Last Updated: 2021-02-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2021-12-31

Brief Summary

The study is designed to assess the safety and immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI GSD 205, as a booster vaccination.

Detailed Description

Study Objectives:

Primary:

To assess safety of Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI GSD 205, as a booster vaccination as a single dose or a three-dose series, and To assess immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI GSD 205, as a booster vaccination as a single dose or a three-dose series

Secondary:

To assess incidence of VEE infection in C-84 boosted personnel.

Conditions

Venezuelan Equine Encephalomyelitis

Study Design

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

Study Groups

Vaccine

VEE C-84 - Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI-GSD 205

Group Type: EXPERIMENTAL

VEE C-84

Intervention Type: BIOLOGICAL

Subjects will receive a 0.5 mL subcutaneous injection in the upper outer aspect of arm; maximum of four boosters in 1 year if titer \<1:20.

Interventions

VEE C-84

Subjects will receive a 0.5 mL subcutaneous injection in the upper outer aspect of arm; maximum of four boosters in 1 year if titer \<1:20.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• At least 18 years old.
• VEE PRNT80 < 1:20 before immunization.
• (females) Negative urine pregnancy test on the 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).
• Previous TC-83 vaccination
• 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.
• 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 C-84.
• 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

Anthony Cardile, DO

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

FY06-27

Identifier Type: OTHER

Identifier Source: secondary_id

A-14350

Identifier Type: -

Identifier Source: org_study_id