A Phase II, Randomized, Double-blind Trial to Assess the Safety and Immunogenicity of MTBVAC (BBV169), with BCG vaccine as a comparator in Healthy adolescent and adult populations
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 164
- 试验地点
- 4
- 主要终点
- Frequencies and co-expression patterns of CD4 cells expressing IFN-γ, and/or TNF, and/or IL-2, induced by MTBVAC and BCG vaccination measured using PBMC Intracellular cytokine assay.
研究概览
简要总结
A Phase -II, double-blind, randomized, safety and immunogenicity trial with BCG vaccine as a comparator. Participants meeting the inclusion and exclusion criteria will be randomized within a study cohort in a 1:1 ratio to receive a single dose of MTBVAC or BCG vaccine administered intradermally on Study Day 0.
A total of 164 participants aged 12-65 years will be enrolled into one of two cohorts based on their based on the QFT - Plus assay results (QFT positive and QFT negative).
Exploratory Objective :
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To evaluate QFT conversion and reversion rates in QFT-negative adults and adolescents
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Humoral immune response in all participants.
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To evaluate the immunogenicity of MTBVAC compared to BCG using WBA at one site.
Exploratory endpoint:
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Qualitative (positive or negative) and quantitative (TB Ag-Nil, IFN-γ concentration) QuantiFERON -Gold Plus assay results. (QuantiFERON conversion will be defined as a positive test without a prior positive test; QuantiFERON reversion will be defined as a negative test following a positive test). QFT will be done on Day 28, 56, 90, and 180.
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Serum IgG Antibodies- Evaluate humoral immune response at Days 0, 28, 56, 90 and 180.
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Antigen-specific CD4/CD8 response - Frequencies and co-expression patterns of CD4/CD8 cells expressing IFN-γ, and/or TNF, and/or IL-2, induced by MTBVAC and BCG, vaccination measured on - Day 0, 28, 56, 90, and 180 using whole blood intracellular cytokine assay using WBA at one site
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Antigen-specific CD8 response: Frequencies and co-expression patterns of CD8 cells expressing IFN-γ, and/or TNF, and/or IL-2, induced by MTBVAC and BCG vaccination measured on Day 0, 28, 56, 90 and 180 using PBMC Intracellular cytokine assay at all sites.
Sample collection
Antigen specific CD4/CD8 response by PBMC --10mL of blood at Days 0, 28, 56, 90, and 180. (At all site)
Antigen specific CD4/CD8 response by WBA-2.0 mL of blood at Days 0, 28, 56, 90, and 180. (At one site)
QuantiFERON Gold Plus test- 5mL of blood on Days screening, 28, 56, 90, and 180.
Serum IgG Antibodies- 2.5 mL of blood at Days 0, 28, 56, 90 and 180.
Sputum Samples for TB diagnosis by Molecular based RT-PCR test (Truenat) - Sputum sample at screening for all participants and participants with suspected TB during the trial period. Urine Sample - UPT (female participants of the childbearing potential) on Days 0, 7, 14, 28, 56, 90, and 180.
HIV test - 2 ml Blood sample on the screening day
Random Blood Sugar- 2 ml Blood on the screening day Serum pregnancy test-On the day of screening the test will be done only for the females of childbearing potential. No additional sample will be collected. The sample collected for the HIV test will be used for serum pregnancy test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Ability to provide written informed consent and informed Assent from Adolescents
- •Participants of either gender of age between ≥12 to ≤65 years at the time of obtaining informed consent.
- •Good general health as determined by the discretion of the investigator (vital signs, medical history, and physical examination).
- •Expressed interest and Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- •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 participants of reproductive potential: Willing to use condoms to ensure effective contraception with the female partner from IP administration until 3 months.
- •No evidence of active TB disease during screening – As confirmed by Truenat test.
- •A negative urine pregnancy test for female participants of childbearing potential.
- •Only participants who are HIV negative
- •Non-Diabetic participants with RBS less than 140 mg/dl and as confirmed by medical history
- •Had BCG vaccination, documented through presence of scar.
排除标准
- •Any chronic febrile illness with oral temperature Greater Than 100.4°F on the day of randomization.
- •Clinical evidence of pulmonary pathology.
- •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
- •Participants with household contacts of patients with active TB disease
- •History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations (any vaccine).
- •History of previous administration of experimental TB 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 immunosuppressors 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 based on medical history and physical examination.
- •Participant who are HIV Positive or on ART.
- •Participants with a medical history of diabetes or those whose RBS levels exceed 140 mg/dL
- •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.
- •History of any neurologic disorders or seizures.
- •History of chronic alcohol consumption and/or drug abuse.
- •Congenital defects in cardio pulmonary and neurological system
- •Pregnant or lactating female.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions during the trial period.
- •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.
- •Administration of any vaccines that are not live attenuated within 30 days before trial vaccine administration.
结局指标
主要结局
Frequencies and co-expression patterns of CD4 cells expressing IFN-γ, and/or TNF, and/or IL-2, induced by MTBVAC and BCG vaccination measured using PBMC Intracellular cytokine assay.
时间窗: Day 0, 28, 56, 90 and 180
次要结局
- 1. The occurrence of immediate adverse events within 30 minutes of vaccination .(2. The occurrence of Solicited adverse events within fourteen days of vaccination)
研究者
Dr V Krishna Mohan
Bharat Biotech international limited