Clinical trial NCT00582088: Safety and Immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine (VEE C-84) as a Booster to VEE TC-83
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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Venezuelan Equine Encephalomyelitis
Keywords: Encephalitis, Viral Infections, Neurologic diseases, Alphavirus Infections, VEE
Lead sponsor: U.S. Army Medical Research and Development Command
Sponsor class: FED
First posted: 2007-12-28
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Frequency of Adverse Events (ITT)
timeFrame: Day 28 after each booster dose
measure: Immunogenicity: TC-83 with PRNT80 ≥ 1:20
timeFrame: Between Days 28 and 35 after each booster dose
measure: Immunogenicity: TC-83 with PRNT80 ≥ 1:20
timeFrame: 12-15 months after booster dose
measure: Immunogenicity: TC-83 with PRNT80 < 1:20
timeFrame: Between Days 28 and 35 after each booster dose
measure: Immunogenicity: TC-83 with PRNT80 < 1:20
timeFrame: 12-15 months after vaccination
measure: Immunogenicity: TC-83 with PRNT80 ≥ 1:20 after three booster doses
timeFrame: After three booster doses
measure: Immunogenicity: TC-83 with PRNT80 ≥ 1:20 12- 15 months after first booster dose
timeFrame: 12- 15 months after first booster dose
measure: Immunogenicity: PRNT80 ≥ 1:20 after 1 dose
timeFrame: After 1 dose
measure: Immunogenicity: PRNT80 ≥ 1:20 12-15 months post dose for new C-84 Protocol.
timeFrame: 12-15 months post dose for new C-84 Protocol
Secondary outcomes:
measure: VEE disease among vaccinated subjects who achieved a PRNT80 ≥ 1:20.
timeFrame: Length of the study
Other outcomes:
Locations:
city: Fort Deterick
country: United States
facility: U.S. Army Medical Research Institute of Infectious Diseases
state: Maryland
Study officials:
affiliation: USAMRIID Medical Division
name: Anthony Cardile, DO
role: PRINCIPAL_INVESTIGATOR
References: