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

Venezuelan Equine Encephalomyelitis Clinical Trial

— VEE C-84  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00582088
• Other study ID #: A-14350
• Secondary ID: FY06-27
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 2008
• Est. completion date: December 2021

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

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: December 2021
• Est. primary completion date: June 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 < 1:20 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.

Related Conditions & MeSH terms

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

Intervention

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.

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	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Immunogenicity: TC-83 with PRNT80 = 1:20 after three booster doses		After three booster doses
Primary	Immunogenicity: TC-83 with PRNT80 = 1:20 12- 15 months after first booster dose		12- 15 months after first booster dose
Primary	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
Primary	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	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