Safety, Tolerability, and Immunogenicity Dose-ranging Study of the Investigational Yellow Fever Vacine (vYF) Candidate Vaccine in Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Number of participants with serious adverse events
研究概览
简要总结
The primary objectives of the study are:
- To describe the safety profile of each of the 3 dosages of vYF and of YF-VAX® within the 28 days post-vaccination and up to the 6 months (Day 180) post-vaccination visit
- To describe the antibody responses elicited by each of the 3 dosages of vYF and by YF-VAX on Day 0 pre-vaccination and then on Day 10, Day 14, Day 28 and 6 months (Day 180) post-vaccination overall and by baseline flavivirus serostatus
- To quantify the detectable yellow fever (YF) vaccinal viremia in each vaccine groups (vYF and YF-VAX) in a subset of subjects on Day 0 visit, Day 1 visit, Day 3 visit, Day 5 visit, Day 7 visit, Day 10 visit, and Day 14 visit.
详细描述
Study duration per participant is approximately 6 months.
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
An observer-blind procedure is followed for the injection of vYF or YF-VAX. Neither the observer Investigator, nor the Sponsor, nor the participants know product is administered. The "vaccinator" is in charge of preparing and administering the products and is not authorized to collect any safety data.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group 1
1 injection of vYF vaccine Dosage 1
干预措施: Yellow fever vaccine (produced on serum-free Vero cells), Dosage 1 vYF vaccine (Biological)
Group 2
1 injection of vYF vaccine Dosage 2
干预措施: Yellow fever vaccine (produced on serum-free Vero cells), Dosage 2 vYF vaccine (Biological)
Group 3
1 injection of vYF vaccine Dosage 3
干预措施: Yellow fever vaccine (produced on serum-free Vero cells), Dosage 3 vYF vaccine (Biological)
Group 4
1 injection of YF-VAX
干预措施: Yellow fever vaccine (Biological)
结局指标
主要结局
Number of participants with serious adverse events
时间窗: From Day 0 to Day 180
Serious adverse events are collected throughout the study
Number of participants with immediate adverse events
时间窗: Within 30 minutes after vaccination
Immediate adverse events are any unsolicited systemic adverse events reported in the 30 minutes after vaccination
Number of participants with hematology and biochemistry out-of-range test results
时间窗: From Day 0 to Day 14
Hematology and biochemistry values that are out-of-range are assessed
Number of participants with Grade 3 fever
时间窗: Within 28 days after vaccination
Grade 3 fever is defined as temperature ≥ 102.1°F
Number of participants with solicited systemic reactions
时间窗: Within 14 days after vaccination
Solicited systemic reactions include fever, headache, malaise, and myalgia
Number of participants with seroconversion to YF virus
时间窗: From Day 0 to Day 28
Seroconversion is defined as a fourfold increase in neutralizing antibody titers as compared to pre-vaccination value. Seroconversion is assessed from Day 0 (pre-vaccination) to Day 10, Day 14 and Day 28.
Number of participants with neutralizing antibody titers against YF virus above pre-defined threshold
时间窗: From Day 0 to Day 180
Pre-defined threshold of 10 1/dilution
Number of participants with YF vaccinal viremia
时间窗: From Day 0 to Day 14
Vaccinal viremia is measured by YF specific quantitative reverse transcription polymerase chain reaction (RT-PCR) assay in samples collected on Day 0, Day 1, Day 3, Day 5, Day 7, Day 10, and Day 14.
Number of participants with unsolicited adverse events
时间窗: Within 28 days after vaccination
Unsolicited (spontaneously reported) adverse events not fulfilling criteria for solicited adverse reactions
Number of participants with YF and flavivirus viremia and out-of-normal-range biological test results in the event of severe fever, or suspicion of neurotropic disease or acute viscerotropic diseases
时间窗: Within 28 days after vaccination
Investigators are provided with guidelines for recognition and assessment of potential viscerotropic and neurotropic events
Number of participants with solicited injection site reactions
时间窗: Within 7 days after vaccination
Solicited injection site reactions include injection site pain, erythema and swelling
Geometric mean titers of neutralizing antibodies against YF virus
时间窗: From Day 0 to Day 180
Geometric mean titer ratio Day 10/Day 0, Day 14/Day 0, Day 28/Day 0 and Day 180/Day 0
Level of YF vaccinal viremia
时间窗: From Day 0 to Day 14
Vaccinal viremia is measured by YF specific quantitative RT-PCR assay in samples collected on Day 0, Day 1, Day 3, Day 5, Day 7, Day 10, and Day 14.
次要结局
未报告次要终点