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

A Phase 2 Open-Label, Safety and Immunogenicity Study of Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI-GSD 205 When Used as a Booster After TC-83 Primary Immunization in Healthy Adults At-Risk for Exposure to Virulent Venezuelan Equine Encephalomyelitis Virus

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 Overview

• Status: Active, not recruiting
• Conditions: Venezuelan Equine Encephalomyelitis
• Intervention / Treatment: Biological: VEE C-84

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.

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Fort Deterick, Maryland, United States, 21702
      • U.S. Army Medical Research Institute of Infectious Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vaccine; VEE C-84 - Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI-GSD 205	Biological: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	12-15 months after vaccination
Immunogenicity: TC-83 with PRNT80 ≥ 1:20 after three booster doses		After three booster doses
Immunogenicity: TC-83 with PRNT80 ≥ 1:20 12- 15 months after first booster dose		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.	After 1 dose
Immunogenicity: PRNT80 ≥ 1:20 12-15 months post dose for new C-84 Protocol.		12-15 months post dose for new C-84 Protocol

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VEE disease among vaccinated subjects who achieved a PRNT80 ≥ 1:20.	The number of confirmed cases of VEE disease among vaccinated subjects who achieved a PRNT80 ≥ 1:20.	Length of the study

Collaborators and Investigators

• Sponsor: U.S. Army Medical Research and Development Command
• Investigators: Principal Investigator: Anthony Cardile, DO, USAMRIID Medical Division

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2008
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: December 19, 2007
• First Submitted That Met QC Criteria: December 27, 2007
• First Posted (Estimate): December 28, 2007

Study Record Updates

• Last Update Posted (Actual): February 11, 2021
• Last Update Submitted That Met QC Criteria: February 10, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Encephalitis, Viral Infections, Neurologic diseases, Alphavirus Infections, VEE
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Encephalitis; Alphavirus Infections; Togaviridae Infections; Encephalomyelitis; Encephalomyelitis, Equine; Encephalomyelitis, Venezuelan Equine
• Other Study ID Numbers: A-14350; FY06-27 (Other Identifier: SIP)