An Open-Labelled, Phase I Clinical Trial to Assess the Safety Reactogenicity, Tolerability and Immunogenicity of a Tuberculosis Vaccine BBV169 (MTBVAC), in Healthy Indian Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To evaluate the safety and reactogenicity of MTBVAC-unsolicited adverse events
研究概览
简要总结
An Open-labelled, Phase I Clinical Trial to Assess the Safety, Reactogenicity, Tolerability, and Immunogenicity of MTBVAC in healthy Indian adult volunteers A total of 30 subjects with Quantiferon®-TB Gold Plus assay negative and ages 18 to 65 years will be enrolled in this trial. All the subjects will receive a single dose of MTBVAC via the intradermal route in the right deltoid region. DSMB meetings will be conducted after Day 28 , Day 90 & Day 180 after vaccinating all subjects.
详细描述
An Open-labelled, Phase I Clinical Trial to Assess the Safety, Reactogenicity, Tolerability, and Immunogenicity of MTBVAC in healthy Indian adult volunteers A total of 30 subjects with Quantiferon®-TB Gold Plus assay negative and ages 18 to 65 years will be enrolled in this trial. All the subjects will receive a single dose of MTBVAC via the intradermal route in the right deltoid region. DSMB meetings will be conducted after Day 28 , Day 90 & Day 180 after vaccinating all subjects.
Study Objectives:
Primary Objective To evaluate the safety and reactogenicity of MTBVAC
End points:
- The occurrence of immediate adverse events within 30mins of vaccination [Time Frame: 30 mins].
- The occurrence of solicited adverse events within fourteen days of vaccination [Time Frame: daily follow- up for 14 days].
- The injection site reactions will be followed-up for 90 days.
- The occurrence of any unsolicited adverse events throughout the study duration [Time Frame: throughout the trial duration].
- The occurrence of serious adverse events (SAEs) [Time Frame: throughout the trial duration].
- AESI (Adverse Event of Special Interest) is to be considered throughout the trial period.
- Hematological, biochemical safety test levels before and after vaccination
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
- •Ability to provide written informed consent.[Audio video consent for vulnerable subjects]
- •Participants of either gender of age between ≥18 to ≤65years.
- •Only QFT negative participants will be included
- •Good general health as determined by the discretion of the investigator (vital signs (heart rate ≥60 to≤100 bpm; blood pressure systolic ≥90 mm Hg and <140 mm Hg; diastolic ≥ 60 mm Hg and <90 mm Hg; oral temperature <100.4ºF), medical history, and physical examination).
- •Expressed interest and availability to fulfill the study requirements.
- •For a female participant of childbearing potential, planning to avoid pregnancy (use of an effective method of contraception or abstinence) from the time of study enrolment until at least 3 months after IP administration.
- •Male subjects of reproductive potential: Use of condoms to ensure effective contraception with the female partner from IP administration until 3 months.
- •No evidence of active TB disease during screening - Normal chest radiograph and no bacteriological positivity by Genexpert plus test of sputum for M. tb
- •Clinically acceptable laboratory values for blood tests and a negative pregnancy test (for childbearing-age women)
- •Seronegative for human immunodeficiency virus 1 and -2 (HIV- 1/2) antibodies, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibodies.
- •Had BCG vaccination at Birth, documented through medical history or presence of scar.
排除标准
- •Any chronic febrile illness with oral temperature > 100°F on the day of enrollment.
- •Evidence of pulmonary pathology as confirmed by chest X-ray.
- •History of any form of TB Disease.
- •Prior or present anti-TB treatment
- •Received Tuberculin Skin Test (TST) within 3 months (90 days) prior to Study Day
- •Clinical evidence of Active TB
- •Subjects with house hold contacts of Active TB
- •History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations (any vaccine).
- •QFT Plus positive subjects.
- •History of allergic disease or reactions.
- •History of previous administration of experimental Mycobacterium tuberculosis vaccines.
- •Use of any investigational or non-registered product (drug or vaccine) in another experimental protocol other than the trial vaccines within 30 days preceding the vaccination, or planned use during the trial period.
- •Any chronic drug therapy to be continued during the trial period.
- •Chronic administration of immune suppressors or other immune- modifying drugs.
- •Administration of any immunoglobulins, any immunotherapy, and/or any blood products within the three months preceding the vaccination, or planned administrations during the trial period.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition (including HIV) based on medical history and physical examination.
- •Any condition or history of any acute or chronic illness or medication, which, in the opinion of the Investigator, may interfere with the evaluation of the trial objectives.
- •A family history of congenital or hereditary immunodeficiency.
- •History of any neurologic disorders or seizures.
- •History of chronic alcohol consumption and/or drug abuse.
- •Major congenital defects.
- •Pregnant or lactating female.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions until 3 months.
- •Those who have been vaccinated with live attenuated vaccines within 30 days of trial vaccine administration and those who are planning to take live attenuated vaccine within 30 days after trial vaccine administration 25 . Administration of any vaccines that are not live attenuated 30 Days before trial vaccine administration -
研究组 & 干预措施
MTBVAC
30 healthy, BCG vaccinated, HIV negative, adults, aged 18 - 65 years, in whom LTB Infection has been excluded by negative QuantiFERON® (QFT) Gold-Plus assay.
干预措施: Tuberculosis Vaccine (Biological)
结局指标
主要结局
To evaluate the safety and reactogenicity of MTBVAC-unsolicited adverse events
时间窗: Through out the trial duration till Day180 Days
The occurrence of any unsolicited adverse events throughout the study duration
To evaluate the safety and reactogenicity of MTBVAC-Serious Adverse Events (SAEs)
时间窗: Through out the trial duration till Day180 Days
Incidence, intensity, and the causality of all adverse events and Serious Adverse Events (SAEs) during the entire study period.
To evaluate the safety and reactogenicity of MTBVAC-AESI (Adverse Event of Special Interest)
时间窗: Through out the trial period till Day180 Days
AESI (Adverse Event of Special Interest) is to be considered throughout the trial period.
To evaluate the safety and reactogenicity of MTBVAC Immediate reaction
时间窗: 30 Minutes of vaccination.
Adverse reactions after administration of each dose
To evaluate the safety and reactogenicity of MTBVAC-Solicited adverse events
时间窗: 14 days
Incidence, intensity, and the causality of all solicited adverse events during the 14-day follow up period after each dose.
To evaluate the safety and reactogenicity of MTBVAC-injection site reactions
时间窗: 90 Days
The injection site reactions will be followed-up for 90days.
To evaluate the safety and reactogenicity of MTBVAC-Hematological safety test levels before and after vaccination
时间窗: before and after vaccination on Day 0
Hematological safety test levels before and after vaccination
To evaluate the safety and reactogenicity of MTBVAC-Biochemical safety test levels before and after vaccination
时间窗: before and after vaccination on Day 0
Biochemical safety test levels before and after vaccination
次要结局
- Cellular immune responses(Days 180)
- Antigen-specificCD4/CD8 response(Days 0,28,90 and 180)