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
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Frequency of Adverse Events (ITT)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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-
- •Any unresolved AEs resulting from a previous immunization.
结局指标
主要结局
Frequency of Adverse Events (ITT)
时间窗: 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
时间窗: 12-15 months after 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
时间窗: 12-15 months after vaccination
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
时间窗: After three booster doses
Immunogenicity: TC-83 with PRNT80 ≥ 1:20 12- 15 months after first booster dose
时间窗: 12- 15 months after first booster dose
Immunogenicity: PRNT80 ≥ 1:20 after 1 dose
时间窗: 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.
时间窗: 12-15 months post dose for new C-84 Protocol
次要结局
- VEE disease among vaccinated subjects who achieved a PRNT80 ≥ 1:20.(Length of the study)