A Multi-Site Phase 2 Open-Label, Safety and Immunogenicity Study of Eastern Equine Encephalitis Vaccine, Inactivated, Dried, TSI-GSD 104 in Healthy Adults At Risk for Exposure to Eastern Equine Encephalitis Virus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 138
- 试验地点
- 2
- 主要终点
- Response Rates of Post Month 6: Day 21-35 PRNT80 Titers
研究概览
简要总结
This study is designed to determine the safety and immunogenicity of Eastern Equine Encephalitis (EEE) Vaccine.
详细描述
This was an open-label, vaccine study of Eastern Equine Encephalitis Vaccine, Inactivated Dried, EEE, TSI-GSD 104 in healthy, adult subjects. No concurrent control group was used. The controls used in this study to assess immunogenicity were historical PRNT80 values obtained in past studies of the EEE vaccine. Rates of adverse events (AEs) were tabulated by relationship to product administration and severity.
The primary objectives are to assess the safety of Eastern Equine Encephalitis Vaccine, Inactivated, Dried EEE, TSI GSD 104, and to assess immunogenicity of Eastern Equine Encephalitis Vaccine, Inactivated, Dried EEE, TSI GSD 104.
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.
- •EEE PRNT80 ≤ 1:
- •EEE PRNT80 ≤ 1:40 for booster series
- •(females) Negative pregnancy test on the same day before vaccination.
- •Not planning pregnancy for 3 months.
- •At risk for exposure to virulent EEE virus (with up-to-date risk assessment).
- •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 events (AE) up to 28 days after each vaccination.
排除标准
- •Over 65 years of age (for Primary Immunization).
- •Clinically significant abnormal lab results including evidence of Hepatitis C, Hepatitis B carrier state, or elevated (2X normal) 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 or exposure to another Alphavirus).
- •Administration of any IND product or live vaccine within 28 days of EEE.
- •Any unresolved AEs resulting from a previous immunization.
研究组 & 干预措施
Vaccination
Inactivated, Dried, TSI-GSD 104, EEE
干预措施: Inactivated, Dried, TSI-GSD 104, EEE (Biological)
结局指标
主要结局
Response Rates of Post Month 6: Day 21-35 PRNT80 Titers
时间窗: Post month 6, days 21-35
Subject response rates for PRNT80 titers for post month 6, days 21-35. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population.
Response Rates of Post Dose 2: Day 21-35 PRNT80 Titers
时间窗: Post dose 2, days 21-35
Subject response rates for PRNT80 titers for post dose 2, days 21-35. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population.
Response Rates of Pre-Month 6 PRNT80 Titers
时间窗: Pre-month 6
Subject response rates for PRNT80 titers of pre-month 6. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population.
Subject Response Rates for PRNT80 Titers
时间窗: 5 years
Subject response rates for PRNT80 titers for vaccinations and all boosters. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population. Four to 5 weeks for primary vaccinations (3) and up to four boost doses in 1 year period for a total duration of up to 5 years (anticipated duration of study execution).
Response Rates of Annual (11-13 Months) PRNT80 Titers
时间窗: Months 11-13
Subject annual response rates for PRNT80 titers for months 11-13. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population.
Response Rates of Post Booster 1: Day 21-35 PRNT80 Titers
时间窗: Post booster 1, days 21-35
Subject response rates for PRNT80 titers for post booster 1, days 21-35. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population.
次要结局
- Number of Subject Experiencing Local and Systemic Adverse Events(vaccination/booster days 0-28 for up to 5 years)