Long-Term Open-Label Primary Vaccination and Booster Dose Study of the Safety and Immunogenicity of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) in At-Risk Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- PRNT80 ≥ 1:40 after primary series
研究概览
简要总结
This study is designed to determine the safety and immunogenicity of an inactivated Rift Valley Fever (RVF) Vaccine in adults
详细描述
The primary objectives are to assess safety of Rift Valley Fever (RVF) Vaccine, Inactivated (TSI-GSD 200) and to assess immunogenicity of Rift Valley Fever (RVF) Vaccine, Inactivated (TSI-GSD 200). The secondary objective is to assess incidence of RVF infection in vaccinated 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.
- •Females of childbearing potential must have a negative serum or urine pregnancy test within 48 hours before each vaccination. Females will be advised not to become pregnant for 3 months after the primary series and each booster dose.
- •Females must not be breast-feeding.
- •Subject must be at risk for exposure to RVF virus.
- •Subject must have an up-to-date (within 1 year) medical history, physical examination, and laboratory tests in their charts and be medically cleared for participation by an investigator. Examinations or tests to qualify for enrollment may be repeated at the discretion of the investigators.
- •Subject must sign and date the approved informed consent document.
- •For initiation of primary series, RVF PRNT80 <1:
- •For RE-ENTRY into this protocol or ROLLOVER from an earlier RVF protocol to receive a booster, RVF PRNT80 <1:40 within past 1 year
排除标准
- •Older than 65 years of age for the primary series vaccination (able to receive booster doses if no other contraindications).
- •Clinically significant abnormal lab results, including evidence of Hepatitis C, Hepatitis B carrier state, or elevated (2 times normal) liver function tests.
- •Personal history of immunodeficiency or current treatment with immunosuppressive medication.
- •Confirmed positive human immunodeficiency virus (HIV) titer.
- •Any medical condition that, at the discretion of the physician, may jeopardize the safety of the subject.
- •Any serious or life-threatening allergies to any component of the vaccine: formalin human serum albumin neomycin streptomycin fetal rhesus lung cells RVF virus inactivated
- •Administration of any Investigational New Drug (IND) product or any vaccine within the 28 days before RVF vaccination.
- •Any unresolved adverse event resulting from a previous immunization.
结局指标
主要结局
PRNT80 ≥ 1:40 after primary series
时间窗: Between Days 28-42
% vaccinated subjects with PRNT80 ≥ 1:40 after primary series (initial responders).
PRNT80 ≥ 1:40 after 6-month mandatory booster dose
时间窗: 7 months
% vaccinated subjects with PRNT80 ≥ 1:40 after 6-month mandatory booster dose (initial responders only).
(PRNT80 < 1:40) who responded with a PRNT80 ≥ 1:40
时间窗: up to 5 years
% initial non-responders (PRNT80 \< 1:40) who responded with a PRNT80 ≥ 1:40 after 1, 2, 3, or 4 booster doses.
Median duration of PRNT80 ≥ 1:40 in initial responders
时间窗: up to 5 years
Median duration of PRNT80 ≥ 1:40 in initial responders after the primary series and 6-month mandatory booster dose.
Median duration of PRNT80 ≥ 1:40 in initial non-responders
时间窗: up to 5 years
Median duration of PRNT80 ≥ 1:40 in initial non-responders after the first booster dose that results in PRNT80 ≥ 1:40.
Number of booster doses needed in initial non-responders to achieve PRNT80 ≥ 1:40
时间窗: up to 1 year
Number of booster doses needed in initial non-responders to achieve PRNT80 ≥ 1:40.
次要结局
- Subjects without symptoms(5 years)
- Subjects with any category of local reaction (grade 1-4).(5 years)
- Subjects with mild, moderate, severe, and potentially life-threatening systemic reactions (grade 1-4).(5 years)
- Subjects with generalized allergic reactions(5 years)