Venezuelan Equine Encephalomyelitis
Conditions
Keywords
Encephalitis, Viral Infections, Neurologic diseases, Alphavirus Infections, VEE
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.
Interventions
BIOLOGICALVEE 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.
Sponsors
U.S. Army Medical Research and Development Command
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity: PRNT80 ≥ 1:20 12-15 months post dose for new C-84 Protocol. | 12-15 months post dose for new C-84 Protocol | — |
| Frequency of Adverse Events (ITT) | Day 28 after each booster dose | 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 | Between Days 28 and 35 after each booster dose | Number of initial responders to TC-83 with PRNT80 ≥ 1:20 after C-84 booster dose. |
| Immunogenicity: TC-83 with PRNT80 < 1:20 | Between Days 28 and 35 after each booster dose | 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 | After three booster doses | — |
| Immunogenicity: TC-83 with PRNT80 ≥ 1:20 12- 15 months after first booster dose | 12- 15 months after first booster dose | — |
| Immunogenicity: PRNT80 ≥ 1:20 after 1 dose | After 1 dose | Number of rollovers from past C-84 booster study with PRNT80 ≥ 1:20 after 1 dose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VEE disease among vaccinated subjects who achieved a PRNT80 ≥ 1:20. | Length of the study | The number of confirmed cases of VEE disease among vaccinated subjects who achieved a PRNT80 ≥ 1:20. |
Countries
United States
Outcome results
None listed