A Longitudinal Phase 2 Study for the Continued Evaluation of the Safety and Immunogenicity of a Live Francisella Tularensis Vaccine, NDBR 101, Lot 4 in Healthy Adults At-Risk for Exposure to Francisella Tularensis
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Number for adverse events.
研究概览
简要总结
This study is designed to determine the safety and immunogenicity of a Live Francisella tularensis Vaccine
详细描述
Study Objectives:
- To assess the safety of live F. tularensis vaccine NDBR 101.
- To assess the immunogenicity of live F. tularensis vaccine NDBR 101.
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 agree to have a urine or serum pregnancy test on vaccination day, immediately before vaccination (Exception: documented hysterectomy or > 3 years of menopause). The results must be negative. Subjects must agree not to become pregnant for 3 months after receipt of the vaccine.
- •Subjects must be at risk for exposure to F. tularensis.
- •Subjects must have an up-to-date (within 1 year) medical history including concomitant medications, physical examination, and laboratory tests on their charts and be medically cleared for participation by an investigator.
- •Subject must be willing to return for all follow-up visits on days 1 and 2, between days 5-9, 12-16, 28-35, and 56-84 (if needed), all visits for serology, and the closeout interview 6 months (±14 days) after vaccination or revaccination.
- •Subject must agree to report any adverse event which may or may not be associated with administration of the test article for at least 28 days after vaccination.
排除标准
- •Over the age of 65 Years.
- •Vaccinated against tularemia within the last 10 years or had a documented, confirmed tularemia infection.
- •Clinically significant abnormal lab results including evidence of hepatitis C, hepatitis B carrier state, or elevated liver function tests (two times the normal range or at the discretion of the PI).
- •Personal history of an immunodeficiency or current treatment with an oral or intravenous immunosuppressive medication.
- •Confirmed HIV* infection.
- •A medical condition that, in the judgment of the Principal Investigator (PI), would impact subject safety.
- •Antibiotic therapy within 7 days before vaccination.
- •Pregnancy or lactation. Subjects must agree not to become pregnant for 3 months after receipt of the vaccine.
- •Any known allergies to any component of the vaccine:
- •Modified casein partial hydrolysate medium Glucose cysteine hemin agar Sucrose gelatin agar stabilizer
- •Administration of another vaccine within 4 weeks of tularemia vaccination.
- •Any unresolved AE resulting from a previous immunization.
结局指标
主要结局
Number for adverse events.
时间窗: 5 years
The nature (body system affected, type (local or systemic), severity, frequency of occurrence, relationship to vaccine, treatment or intervention offered if any, and resolution or outcome) and frequency of adverse events for the assessment population (all subjects receiving one or more vaccinations under this protocol).
Microagglutination (MA) titer that shows a ≥ 4-fold rise in antibody titer after vaccination.
时间窗: 28-35 days
Seroconversion will be evaluated for subjects who are compliant with the titer schedule. Seroconversion is defined as microagglutination (MA) titer that shows a ≥ 4-fold rise in antibody titer after vaccination.
Number of erythematous papule, vesicle, and/or eschar with or without underlying induration
时间窗: 7 (± 2 days) after vaccination
Incidence of positive "take" reaction (development of an erythematous papule, vesicle, and/or eschar with or without underlying induration) following vaccination for all subjects regardless of compliance.
次要结局
- Number of tularemia cases following exposure to F. tularensis in a successfully vaccinated individual(5 years)