A prospective open-label, randomized, controlled Phase-I clinical study to evaluate the safety, tolerability and reactogenicity of single dose of Biological E’s Yellow Fever Vaccine administered to 18-45 years-old healthy adults.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- 1. Proportion of subjects with solicited local and systemic adverse reactions
研究概览
简要总结
This is a prospective open-label, randomized, controlled Phase-I clinical study to evaluate the safety, tolerability and reactogenicity of single dose of Biological E’s Yellow Fever Vaccine administered to 18-45 years-old healthy adults.
A total of 90 adult subjects will be randomized 1:1:1 to either receive the investigational YF vaccine subcutaneously or intramuscularly, or a licensed comparator.
The study will be conducted in compliance with NDCT Rules, ICH and Indian good clinical practice guidelines in force at the time of study conduct.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Yellow Fever vaccine-naïve male and the non-pregnant, non-lactating female human volunteers aged between 18 and 45 years of age (both inclusive) at the time of vaccination.
- •Subject, in the opinion of the investigator, has ability to communicate and will comply, with the requirements of the protocol 3.Written or thumb printed informed consent (including audio-visual recording of consent process) obtained from the subject prior to performing any study specific procedure.
- •Subjects considered of stable health as judged by the principal investigator based on personal medical history, protocol specific laboratory parameters and clinical examination findings before entering into the study.
- •5.Subjects that are negative for Human Immunodeficiency Virus (HIV), Hepatitis B, Hepatitis C by laboratory testing.
- •Negative urine pregnancy test for female subjects of childbearing potential at screening.
- •Female participants of non-childbearing potential.
排除标准
- •1.Individuals with previous history and/or existing laboratory test reports suggesting past infection by a flavivirus such as YF, tick-borne encephalitis (TBE), Japanese encephalitis virus (JE), dengue fever, or West Nile Virus (WNV).
- •Subjects with a travel history to a YF endemic area [Africa or South America including participants who plan to travel to these areas prior to completion of the study].
- •Individuals with body temperature greater than or equal to 100.4°F within 3 days of intended study vaccine administration.
- •Individuals with any progressive unstable or uncontrolled clinical conditions according to judgment of the investigator (e.g., neurological, neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease);
- •Subject inability to understand and follow required study procedures, keep appointments, or are planning to relocate during the study period;
- •Individuals with history of any illness or any laboratory abnormality that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study;
- •Subject with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time or history of receipt of anti-coagulants in the past 3 weeks;
- •Individuals with a history of thymus disorders such as thymoma, myasthenia gravis, and those that are post thymectomy.
- •History of anaphylaxis, allergy, hypersensitivity or allergic reaction to any vaccine-related component; and hypersensitivity to eggs or chicken proteins;
- •Individuals participating in any other clinical trial within 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study;
- •Any other reason that in the opinion of the investigator may interfere with the evaluation required by the study objectives.
结局指标
主要结局
1. Proportion of subjects with solicited local and systemic adverse reactions
时间窗: 1. During first 60 minutes of post vaccination observation period at baseline and for subsequent 10 consecutive days thereafter | 2. During the total post vaccination follow up period of 28 days. | 3. During the total post vaccination follow up period of 28 days.
2. Proportion of subjects with unsolicited local and systemic adverse events (AEs)
时间窗: 1. During first 60 minutes of post vaccination observation period at baseline and for subsequent 10 consecutive days thereafter | 2. During the total post vaccination follow up period of 28 days. | 3. During the total post vaccination follow up period of 28 days.
3. Serious adverse events (SAEs) and medically attended adverse events (MAAEs) if any,
时间窗: 1. During first 60 minutes of post vaccination observation period at baseline and for subsequent 10 consecutive days thereafter | 2. During the total post vaccination follow up period of 28 days. | 3. During the total post vaccination follow up period of 28 days.
次要结局
- Geometric mean titres (GMT) of YF neutralizing antibody levels(At baseline, and at Day 28)
- Proportion of subjects achieving seroconversion(at Day 28, post single dose vaccination.)
- Proportion of subjects achieving seroprotection(at Day 28, post single dose vaccination.)
研究者
Dr Subhash Thuluva
Biological E.Limited