NCT00584194已完成2 期
Parts A&B: Evaluation of the Safety and Immunogenicity of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200), A Phase 2 Study
U.S. Army Medical Research and Development Command2 个研究点 分布在 1 个国家目标入组 278 人开始时间: 2004年6月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 278
- 试验地点
- 2
- 主要终点
- Safety: All Incidences of Erythema
研究概览
简要总结
This study is designed to determine the safety and immunogenicity of a Rift Valley Fever (RVF) Vaccine
详细描述
Study Objectives:
The objectives of this two-part, primary immunization and booster dose, study are to continue to collect safety data on Rift Valley Fever (RVF) Vaccine, Inactivated (TSI-GSD 200); and, to continue to collect immunogenicity data on Rift Valley Fever (RVF) Vaccine, Inactivated (TSI-GSD 200) and analyze interim data to determine whether a 6-month dose is indicated; and, to provide potential protection for personnel at risk for occupational exposure to the RVF virus and collect data on incidence of occupational RVF infection (subclinical and clinical) in immunized 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
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parts A & B:
- •At least 18 years old, or if active military duty, 17 years old,
- •Females of childbearing potential must agree to have a urine pregnancy test within 48 hours before receipt of each dose of vaccine. The test results must be negative. Females will be advised not to become pregnant for 3 months after the primary series and each booster dose, and must not be breast-feeding,
- •Subject must be actively enrolled in the SIP to be vaccinated at USAMRIID or be otherwise authorized (with documentation) by the DOD
- •Subjects must be at risk for exposure to RVF virus,
- •Subjects 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 may be repeated within 1 year at the discretion of the enrolling physician.
- •Volunteer must have signed and dated the approved informed consent (Volunteer Agreement Explanation and Affidavit).
- •Additional Inclusion Criteria for Part B:
- •Completion of primary series and any follow-up titer (PRNT80) < 1:40 from the current or a previous RVF IND 365 protocol.
排除标准
- •Parts A & B:
- •Clinically significant abnormal lab results including evidence of Hepatitis C, Hepatitis B or carrier state, or elevated liver function tests.
- •Personal history of immunodeficiency or current treatment with immunosuppressive medication, at the discretion of the physician.
- •Confirmed HIV infection.
- •Any medical condition that, at the discretion of the physician, may jeopardize the safety of the volunteer.
- •Any serious or life-threatening allergies to any component of the vaccine: formalin, human serum albumin, neomycin, streptomycin
- •Administration of any other vaccine within 28 days of any dose of RVF vaccine.
- •Any unresolved adverse event resulting from a previous immunization.
- •Additional Exclusion Criteria for Part B:
- •An adequate PRNT80 (≥ 1:40) after completion of primary series.
结局指标
主要结局
Safety: All Incidences of Erythema
时间窗: 12 months
Collect data on the occurrence of AEs and SAEs in reference to Erythema (most frequently reported AE) in parts A and B of the study
次要结局
- Immunogenicity: Geometric Mean Titers Before 6-month Booster(Before 6-month booster)
- Immunogenicity: Geometric Mean Titers After 6-month Booster(month 6 after dose 4)
- Immunogenicity: Geometric Mean Titers After 3rd Vaccination(28 days after dose 3)
- Immunogenicity: Geometric Mean Titers at 12 Months(at 12 months)
研究者
研究点 (2)
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