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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT00582088
First received: December 19, 2007
Last updated: April 8, 2015
Last verified: April 2015

December 19, 2007
April 8, 2015
January 2008
November 2015   (final data collection date for primary outcome measure)
  • Safety [ Time Frame: Day 28 after each booster dose ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Between Days 28 and 35 after each booster dose ] [ Designated as safety issue: No ]
    Number of initial responders to TC-83 with PRNT80 ≥ 1:20 after C-84 booster dose.
  • Immunogenicity: TC-83 with PRNT80 ≥ 1:20 [ Time Frame: 12-15 months after booster dose ] [ Designated as safety issue: No ]
    Number of initial responders to TC-83 with PRNT80 ≥ 1:20 after C-84 booster dose.
  • Immunogenicity: TC-83 with PRNT80 < 1:20 [ Time Frame: Between Days 28 and 35 after each booster dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12-15 months after vaccination ] [ Designated as safety issue: No ]
    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 [ Time Frame: After three booster doses ] [ Designated as safety issue: No ]
  • Immunogenicity: TC-83 with PRNT80 ≥ 1:20 12- 15 months after first booster dose [ Time Frame: 12- 15 months after first booster dose ] [ Designated as safety issue: No ]
  • Immunogenicity: PRNT80 ≥ 1:20 after 1 dose [ Time Frame: After 1 dose ] [ Designated as safety issue: No ]

    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. [ Time Frame: 12-15 months post dose for new C-84 Protocol ] [ Designated as safety issue: No ]
Safety: Frequency adverse events will be evaluated for all intent-to-treat subjects: headache, myalgia, fever, fatigue, sore throat, erythema, tenderness, and warmth. Immunogenicity: Measured by the 80% plaque-reduction neutralization titer (PRNT80). [ Time Frame: AEs recorded through 28 days after each booster dose; SAEs recorded for study duration; Immunogencity:PRNT80 at days 21 and 35 after each booster dose and 12-15 months after vaccination ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00582088 on ClinicalTrials.gov Archive Site
VEE disease among vaccinated subjects who achieved a PRNT80 ≥ 1:20. [ Time Frame: Length of the study ] [ Designated as safety issue: No ]

The number of confirmed cases of VEE disease among vaccinated subjects who achieved a PRNT80

≥ 1:20.

Safety: Frequency of all other adverse events for all intent-to-treat subjects; Immunogenicity: Frequency of confirmed cases of VEE disease among vaccinated subjects compliant with titer schedule with documented exposure after working with VEE virus. [ Time Frame: Safety: AE's: 28 days after vaccination; SAE's: duration of study; Immunogenicity: duration of study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine (VEE C-84) as a Booster to VEE TC-83
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 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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Venezuelan Equine Encephalomyelitis
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.
Experimental: Vaccine
VEE C-84 - Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI-GSD 205
Intervention: Biological: VEE C-84
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
500
June 2016
November 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00582088
A-14350, FY06-27
No
U.S. Army Medical Research and Materiel Command
U.S. Army Medical Research and Materiel Command
Not Provided
Principal Investigator: Mark Goldberg, MD USAMRIID Medical Division
U.S. Army Medical Research and Materiel Command
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP