NCT06873282已完成2 期
Randomized, Double-blind, Placebo-controlled Phase 2 Trial of ТВ/Flu-05Е Intranasal Vector Vaccine for the Prevention of Tuberculosis Infection in BCG-vaccinated Volunteers Aged 18-50 Years
Research Institute of Influenza, Russia3 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2023年12月13日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 3
- 主要终点
- Level of TB antigen-specific cytokine producing T-cells
研究概览
简要总结
The aim of the study is to investigate immunogenicity and safety of the TB/Flu-05E single-dose intranasal vaccine for the prevention of Tuberculosis infection in BCG-vaccinated Volunteers aged 18-50 years
详细描述
Study includes 160 participants aged 18 to 50, randomized at 3:1 ratio, to receive single intranasal dose of TB/Flu-05E vaccine or placebo, correspondingly. Duration of the study for each participant is about 4 months (no more than 114 days).
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)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy BCG-vaccinated men and women aged 18 to 50 years
- •Availability of signed informed consent
- •Diagnosed "healthy" according to the data of standard clinical, laboratory and instrumental examination methods, with the absence of clinically significant changes. Participants with chronic conditions that do not require special treatment, such as diabetes mellitus, hypertension, or heart disease, are eligible to participate in this study if the investigator considers the participant's condition to be medically stable
- •The ability and willingness to make entries in the diary of self-observation, as well as to carry out all the visits foreseen in the study for control medical observation
- •Consent of study participants to use effective contraceptive methods throughout their participation in the study. In this study, volunteers can use the following methods of contraception:
- •Barrier methods:
- •male condom and spermicide
- •cervical cap and spermicide
- •vaginal diaphragm and spermicide
- •Intrauterine device
- •Hormonal intrauterine device
- •Hormonal contraceptives:
- •hormonal implants
- •hormone injections
- •combined oral contraceptives
- •mini-pill
- •contraceptive patch
- •Abstinence from sexual activity.
- •Body weight ≥ 50 kg
- •Negative test for alcohol in exhaled air
- •Values of the complete blood count and biochemical blood analysis (during the screening) within 0.9*reference range lower limit and 1,1 * reference range upper limit
- •Negative tests for HIV, hepatitis B, hepatitis C, and syphilis
- •Absence of pathological changes on the chest X-ray (fluorogram of the lungs).
排除标准
- •Participation in another clinical study within three months prior to the start of the current study; planning to participate in another study during the current study period
- •Clinical, radiological or laboratory signs of active or previously transferred tuberculosis of any localization.
- •Existence in the past or present of contact with patients with any form of tuberculosis (at home, at work, in the circle of friends and acquaintances)
- •Tuberculous infection confirmed by the TB-FERON IGRA laboratory test
- •Immunization with BCG within six months prior to enrollment in the current study
- •Contact with COVID-19 patients within 14 days prior to the start of the clinical study
- •Positive rapid test result for SARS-CoV-2 antigen
- •Immunization with any other non-study vaccine product within three weeks prior to enrollment in the current study, or refusal to postpone such until the end of the three-week period after completion of the current study
- •Regular use of nasal irrigation therapy during the last six months prior to enrollment in the current study or episodic use of the above method of treatment in the two weeks prior to the screening
- •History of frequent nosebleeds (>5) during the year prior to the current study
- •Features of the nasal anatomy that may complicate intranasal administration of the study drug.
- •Surgical interventions or traumatic injuries in the sinus area, paranasal sinuses, or traumatic injuries of the nose within a month before screening
- •Symptoms of acute respiratory disease, including fever, or other acute illness at the time of screening or within two weeks prior to screening
- •Treatment with immunoglobulins or other blood derived medications in the three months prior to screening or planning such treatment during the period of participation in the current study
- •History of bronchial asthma
- •Hypersensitivity and the presence of severe allergic reactions, including Quincke's edema, anaphylactic shock after the previous administration of any vaccine
- •History of wheezing after previous immunization with live influenza vaccine
- •Other adverse events after immunization (fever above 40°C, syncope, non-febrile convulsions, anaphylaxis) when there is a minimal likelihood that they are associated with a previous administration of any vaccine
- •Suspicion of hypersensitivity to any component of the study vaccine, including egg protein
- •Acute or chronic clinically significant lung, cardiovascular, hepatic, endocrine, neurological, or psychiatric disorders, or impaired renal function identified by history, physical examination, or clinical laboratory findings that, in the opinion of the investigator, may influence the outcome of the study
- •History of oncological diseases
- •History of thrombocytopenic purpura or bleeding disorders
- •History of convulsions
- •Chronic alcohol dependence or chronic use of illicit drugs, drug abuse
- •Claustrophobia and social phobia according to history and / or available medical records
- •Inability to read Russian; inability or unwillingness to understand the essence of the study
- •Military personnel undergoing military service on conscription
- •Special diet (eg, vegetarian, vegan, salt-restricted) or lifestyle (night work, extreme physical activity)
- •Any condition that, in the opinion of the investigator, may increase the risk to the health of a volunteer participating in the study or affect the results of the study
研究组 & 干预措施
Placebo
Placebo Comparator
Single dose of Placebo
干预措施: Placebo (Other)
TB/Flu-05E
Experimental
Single dose of TB/Flu-05E vector vaccine
干预措施: TB/Flu-05E (Biological)
结局指标
主要结局
Level of TB antigen-specific cytokine producing T-cells
时间窗: Days 1, 7, 21
Change from baseline in the level of cytokine producing T-cells upon in vitro stimulation of PBMC with M. tuberculosis peptide epitopes (TB10.4, HspX) measured by FACS/ELISPOT
Level of TB antigen-specific cytokine release in whole blood assay
时间窗: Days 1, 7, 21
Change from the baseline of the cytokine concentration in whole-blood cytokine release assay upon in vitro stimulation with M. tuberculosis peptide epitopes (TB10.4, HspX) measured in ELISA
次要结局
- Level of TB antigen-specific IgG antibody in serum(Days 1, 21, 111±3)
- Number of participants with local and systemic adverse events (AEs) and serious adverse events (SAEs)(Throughout the study, average 4 months)
- Percent of participants with T-cell response to M. tuberculosis antigens(Days 7, 21)
- Level of B-cell and Tfh-cell populations(Days 1, 7, 21)
- Level of mucosal IgA antibody in nasal secret(Days 1, 21)
- Level of influenza-specific cytokine producing T-cells(Days 1, 7, 21)
- Influenza specific systemic antibody immune response(Days 1, 21, 111±3)
研究者
Tatyana Zubkova
Head of the clinical department
Research Institute of Influenza, Russia
研究点 (3)
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