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
  Purpose

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.


Condition Intervention Phase
Venezuelan Equine Encephalomyelitis
Biological: VEE C-84
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by U.S. Army Medical Research and Materiel Command:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.



Estimated Enrollment: 500
Study Start Date: January 2008
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00582088

Locations
United States, Maryland
U.S. Army Medical Research Institute of Infectious Diseases
Fort Detrick, Maryland, United States, 21702
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Mark Goldberg, MD USAMRIID Medical Division
  More Information

No publications provided

Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT00582088     History of Changes
Other Study ID Numbers: A-14350, FY06-27
Study First Received: December 19, 2007
Last Updated: April 8, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by U.S. Army Medical Research and Materiel Command:
Encephalitis, Viral Infections, Neurologic diseases, Alphavirus Infections, VEE

Additional relevant MeSH terms:
Encephalomyelitis
Encephalomyelitis, Equine
Encephalomyelitis, Venezuelan Equine
Alphavirus Infections
Arbovirus Infections
Brain Diseases
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
Encephalitis
Encephalitis, Viral
Nervous System Diseases
RNA Virus Infections
Togaviridae Infections
Virus Diseases

ClinicalTrials.gov processed this record on July 27, 2015