Safety and Immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine (VEE C-84) as a Booster to VEE TC-83 (VEE C-84)
Primary Purpose
Venezuelan Equine Encephalomyelitis
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VEE C-84
Sponsored by
About this trial
This is an interventional prevention trial for Venezuelan Equine Encephalomyelitis focused on measuring Encephalitis, Viral Infections, Neurologic diseases, Alphavirus Infections, VEE
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.
Sites / Locations
- U.S. Army Medical Research Institute of Infectious Diseases
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vaccine
Arm Description
VEE C-84 - Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI-GSD 205
Outcomes
Primary Outcome Measures
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.
Immunogenicity: TC-83 with PRNT80 ≥ 1:20
Number of initial responders to TC-83 with PRNT80 ≥ 1:20 after C-84 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.
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.
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.
Immunogenicity: TC-83 with PRNT80 ≥ 1:20 after three booster doses
Immunogenicity: TC-83 with PRNT80 ≥ 1:20 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.
Immunogenicity: PRNT80 ≥ 1:20 12-15 months post dose for new C-84 Protocol.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00582088
First Posted
December 19, 2007
Last Updated
February 10, 2021
Sponsor
U.S. Army Medical Research and Development Command
1. Study Identification
Unique Protocol Identification Number
NCT00582088
Brief Title
Safety and Immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine (VEE C-84) as a Booster to VEE TC-83
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 2008 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
U.S. Army Medical Research and Development Command
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venezuelan Equine Encephalomyelitis
Keywords
Encephalitis, Viral Infections, Neurologic diseases, Alphavirus Infections, VEE
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vaccine
Arm Type
Experimental
Arm Description
VEE C-84 - Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI-GSD 205
Intervention Type
Biological
Intervention Name(s)
VEE C-84
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frequency of Adverse Events (ITT)
Description
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
Title
Immunogenicity: TC-83 with PRNT80 ≥ 1:20
Description
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
Title
Immunogenicity: TC-83 with PRNT80 ≥ 1:20
Description
Number of initial responders to TC-83 with PRNT80 ≥ 1:20 after C-84 booster dose.
Time Frame
12-15 months after booster dose
Title
Immunogenicity: TC-83 with PRNT80 < 1:20
Description
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
Title
Immunogenicity: TC-83 with PRNT80 < 1:20
Description
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
Title
Immunogenicity: TC-83 with PRNT80 ≥ 1:20 after three booster doses
Time Frame
After three booster doses
Title
Immunogenicity: TC-83 with PRNT80 ≥ 1:20 12- 15 months after first booster dose
Time Frame
12- 15 months after first booster dose
Title
Immunogenicity: PRNT80 ≥ 1:20 after 1 dose
Description
Number of rollovers from past C-84 booster study with PRNT80
≥ 1:20 after 1 dose.
Time Frame
After 1 dose
Title
Immunogenicity: PRNT80 ≥ 1:20 12-15 months post dose for new C-84 Protocol.
Time Frame
12-15 months post dose for new C-84 Protocol
Secondary Outcome Measure Information:
Title
VEE disease among vaccinated subjects who achieved a PRNT80 ≥ 1:20.
Description
The number of confirmed cases of VEE disease among vaccinated subjects who achieved a PRNT80
≥ 1:20.
Time Frame
Length of the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Cardile, DO
Organizational Affiliation
USAMRIID Medical Division
Official's Role
Principal Investigator
Facility Information:
Facility Name
U.S. Army Medical Research Institute of Infectious Diseases
City
Fort Deterick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
12. IPD Sharing Statement
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Safety and Immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine (VEE C-84) as a Booster to VEE TC-83
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