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

Phase 2UnknownNCT00582088

U.S. Army Medical Research and Development Command500 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

500

Conditions

Venezuelan Equine Encephalomyelitis

Interventions

VEE C-84BIOLOGICAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

U.S. Army Medical Research Institute of Infectious Diseases

Fort Deterick, Maryland, United States

Outcomes

Primary Outcomes

Frequency of Adverse Events (ITT)

Frequency of the following adverse events will be evaluated for all intent-to-treat subjects: headache, myalgia, fever, fatigue, sore throat, erythema, tenderness, and warmth.

Time frame: Day 28 after each booster dose

Immunogenicity: TC-83 with PRNT80 ≥ 1:20

Number of initial responders to TC-83 with PRNT80 ≥ 1:20 after C-84 booster dose.

Time frame: Between Days 28 and 35 after each booster dose

Immunogenicity: TC-83 with PRNT80 ≥ 1:20

Number of initial responders to TC-83 with PRNT80 ≥ 1:20 after C-84 booster dose.

Time frame: 12-15 months after booster dose

Immunogenicity: TC-83 with PRNT80 < 1:20

Number of initial responders to TC-83 who are non-responders (PRNT80 \< 1:20) to C-84 booster dose.

Time frame: Between Days 28 and 35 after each booster dose

Immunogenicity: TC-83 with PRNT80 < 1:20

Number of initial responders to TC-83 who are non-responders (PRNT80 \< 1:20) to C-84 booster dose.

Time frame: 12-15 months after vaccination

Immunogenicity: TC-83 with PRNT80 ≥ 1:20 after three booster doses

Time frame: After three booster doses

Immunogenicity: TC-83 with PRNT80 ≥ 1:20 12- 15 months after first booster dose

Time frame: 12- 15 months after first booster dose

Immunogenicity: PRNT80 ≥ 1:20 after 1 dose

Number of rollovers from past C-84 booster study with PRNT80 ≥ 1:20 after 1 dose.

Time frame: After 1 dose

Data from ClinicalTrials.gov

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