NCT05178901已完成1 期
A Phase 1 Randomized, Single Center, Double-Blind, Placebo-Controlled, Dose-Response and Open-Label or Single Blind Booster Study to Evaluate the Safety and Immunogenicity of RVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events as assessed by the Toxicity Grading Scale
研究概览
简要总结
A Phase 1 Study to Evaluate the Safety and Immunogenicity of rVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects
详细描述
A Phase 1 Randomized, Single Center, Double-Blind, Placebo-Controlled, Dose-Response Study to Evaluate the Safety and Immunogenicity of rVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind for placebo-controlled portion; open label for Booster advance subset; single blind for remaining Booster
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For Booster cohort only: received PHV02 (or placebo)
- •Healthy, adult, male or non-pregnant, non-lactating females
- •Given written informed consent
- •No clinically significant health problems
- •Agree to avoid conception through Day 29
- •Agree to minimize blood and body fluid exposures to others after vaccination through Day 29
- •Agree to avoid exposure to immunocompromised persons after vaccination through Day 29
- •Agree to avoid employment in industry involved with livestock after vaccination through Day 29
排除标准
- •Signs or symptoms of acute COVID-19 within 1 week before vaccination.
- •Prior infection with Nipah virus or suspected Henipavirus
- •Healthcare worker with direct physical contact with patients
- •Childcare worker in direct contact with children 5 years old or younger
- •Household contact who is immunodeficient, or on immunosuppressive medication
- •Hands-on food preparation job
- •Primary care or treatment of cattle, horses, llamas or swine
- •Hepatitis B, hepatitis C, HIV-1, HIV-2, diabetes, atopic dermatitis (eczema), chronic inflammatory disease, autoimmune or autoinflammatory disorder, malignancy, chronic or active neurologic disorder, ;
- •History of severe reactions to any vaccine or history of severe allergies
- •Receipt of another investigational vaccine within 30 days or a licensed vaccine within 14 days (live vaccine within 30 days)
- •Known allergy to components of PHV02
- •Injection sites obscured by tattoos or physical condition
- •Significant psychiatric or medical condition or laboratory abnormality on screening
- •History of Guillain Barre Syndrome or any chronic or acute neurological disorder
- •Alcohol or illicit drug abuse within past 5 years
- •Pregnant or lactating female
- •Administration of blood or IgG within 120 days preceding study
- •History of blood donation within 60 days of study
- •Unwilling to undergo diagnostic evaluation of rash (skin biopsy, if indicated) or joint symptoms (athrocentesis if indicated by joint effusion), in both cases if acceptable to subject
- •History of chronic autoimmune/autoinflammatory disease
- •Elective surgery planned during the study period
- •Subjects who have not adhered to and do not agree to adhere to local and institutional guidelines for COVID-19 prevention or testing
- •Any subject from the Pioneer/Full cohort who experienced a hypersensitivity reaction to study vaccine or a single clinically significant Grade 3 adverse event or serious adverse event, unless deemed unrelated to vaccination, will be followed for safety and immunogenicity, but will not be eligible to enter the Booster Cohort
研究组 & 干预措施
PHV02 2x10^5 pfu
Experimental
干预措施: PHV02 (Biological)
PHV02 2x10^6 pfu
Experimental
干预措施: PHV02 (Biological)
PHV02 2x10^7 pfu
Experimental
干预措施: PHV02 (Biological)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
PHV02 5x10^8 pfu (Boost)
Experimental
干预措施: PHV02 (Biological)
PHV02 5x10^8 pfu (Prime)
Experimental
干预措施: PHV02 (Biological)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by the Toxicity Grading Scale
时间窗: 42 days after vaccination
for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials
Number of participants with Nipah-specific antibody and neutralizing antibody responses as assessed by ELISA
时间窗: 29 days after vaccination
for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials
次要结局
未报告次要终点
研究者
研究点 (1)
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