NCT04152161终止2 期
A Randomized, Placebo Controlled, Observer-Blind, Phase IIb Study to Evaluate the Efficacy, Safety, and Immunogenicity of BCG Revaccination in Healthy Adolescents for the Prevention of Sustained Infection With Mycobacterium Tuberculosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1,836
- 试验地点
- 1
- 主要终点
- Number of Participants With Sustained QuantiFERON®-TB Gold Plus Assay (QFT) Conversion From a Negative to Positive Test Based on Positive QFT Test Results
研究概览
简要总结
The purpose of this study is to demonstrate the efficacy of Bacille Calmette Guerin (BCG) revaccination against sustained Mycobacterium tuberculosis infection versus placebo in previously BCG vaccinated QuantiFERON®-TB Gold Plus Assay (QFT) negative, healthy adolescents.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant between ≥ 10 years and ≤ 18 years on Study Day 1
- •General good health, confirmed by medical history and physical examination
- •Vaccinated with Bacille Calmette Guerin (BCG) at least 5 years ago, documented through medical history or by presence of healed BCG scar
- •Tests QuantiFERON®-TB Gold Plus Assay (QFT) negative at screening.
- •For female participants: not pregnant and agrees to avoid pregnancy throughout the first 12 months of the study. Women physically capable of pregnancy must agree to use an acceptable method of avoiding pregnancy during this period. Acceptable methods of avoiding pregnancy include sexual abstinence (not engaging in sexual intercourse), a confirmed sterile partner, or at least 2 contraception methods from the following list: male or female condom, diaphragm, intrauterine devices (IUDs), hormonal contraceptive (oral, injection, transdermal patch, or implant).
- •Agrees to stay in contact with the study site for the duration of the study, provide updated contact information as necessary, and has no current plans to move from the study area for the duration of the study
- •Capable of giving signed informed consent/assent and completes the written informed consent/assent process.
排除标准
- •Acute illness on Study Day
- •NOTE: This is a temporary exclusion for which the participant may be re-evaluated
- •Body temperature ≥37.5 degree Celsius on Study Day
- •NOTE: This is a temporary exclusion for which the participant may be re-evaluated
- •History or evidence of any clinically significant disease, including severe eczema and severe asthma, or any acute or chronic illness that might affect the safety, immunogenicity, or efficacy of study vaccine in the opinion of the investigator
- •Any current medical, psychiatric, occupational, or substance abuse problems that, in the opinion of the investigator, will make it unlikely that the participant will comply with the protocol
- •History of autoimmune disease
- •History or evidence of active tuberculosis (TB) disease
- •History or laboratory evidence of any past or present possible immunodeficiency state including, but not limited to, any laboratory indication of human immunodeficiency virus - 1 (HIV-1) infection
- •History of allergic disease that is likely to be exacerbated by any component of the study vaccine
- •History of treatment for active TB disease or history of latent Mycobacterium tuberculosis infection
- •Received a tuberculin skin test within 6 months prior to Study Day 1
- •Received immunosuppressive treatment, e.g., chemotherapy, biologics or radiation therapy, or used immunosuppressive medication (daily steroid equivalent of ≥5 milligrams prednisone) within 42 days before Study Day
- •Inhaled and topical corticosteroids are permitted.
- •Received immunoglobulin or blood products within 42 days before Study Day 1
- •Planned administration/administration of a licensed vaccine in the period starting 28 days before and ending 28 days after Study Day 1
- •Received investigational TB vaccine at any time prior to Study Day 1
- •Received any investigational drug therapy or investigational vaccine within 180 days before Study Day 1, or planned participation in any other clinical trial using investigational product during the study period
- •Laboratory values from the most recent blood collected prior to randomization outside the normal range that are suggestive of a disease state. Grade 1 abnormalities (as per Division of Acquired Immunodeficiency Syndrome toxicity table version 2.1) do not lead to exclusion if the investigator considers them not clinically significant
- •Urinalysis abnormality greater than Grade 1 on the Toxicity Scale (with the exception of hematuria in a menstruating female), or urinalysis abnormality judged clinically significant by the investigator
- •Shared residence with an individual who is receiving TB treatment or with someone who is known to have incompletely treated TB. e.g., Xpert Mycobacterium tuberculosis (MTB)/rifampicin (RIF) assay-positive, polymerase chain reaction-positive, culture-positive, smear-positive TB, or clinically diagnosed unconfirmed TB
- •Child in Care
- •Female participants currently pregnant or lactating/nursing; or positive serum pregnancy test during screening or on Day 1, prior to vaccination, or planning a pregnancy within the first 12 months after study intervention
研究组 & 干预措施
Bacille Calmette Guerin (BCG) group
Experimental
干预措施: BCG vaccine SSI (Biological)
Placebo group
Placebo Comparator
干预措施: Placebo (Biological)
结局指标
主要结局
Number of Participants With Sustained QuantiFERON®-TB Gold Plus Assay (QFT) Conversion From a Negative to Positive Test Based on Positive QFT Test Results
时间窗: Up to 48 months
Sustained conversion was defined as sustained QFT conversion from a negative to positive test, with initial conversion at any time after a first negative QFT result post randomization (Day 71 or subsequent visit if Day 71 result was not available), and remaining QFT positive at 3- and 6-months post-conversion.
次要结局
- Number of Participants With Sustained QFT Conversion From a Negative to Positive Test Based on Positive QFT Test Results at 36-Months Follow-up or Discontinued Early(36 Months Follow-up)
- Number of Participants With Sustained QFT Conversion From a Negative to Positive Test Based on Positive QFT Test Results at 48-Months Follow-up or Discontinued Early(48 Months Follow-up)
- Number of Participants With Serious and Non-serious Solicited Adverse Events (AEs) Through 7 Days Post Vaccination(Day 1 through Day 7)
- Number of Participants With Unsolicited AEs Through Day 28, as Well as Solicited AEs That Were Ongoing at Day 7 After Vaccination(Day 1 through Day 28)
- Number of Participants With Serious Adverse Events (SAEs)(Up to 6 months)
- Number of Participants With AEs of Special Interest(Up to 6 months)
- Number of Participants With Serious Adverse Drug Reactions (ADRs)(Up to 48 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Phase 1 ID93 + GLA-SE Vaccine Trial in BCG-Vaccinated Healthy Adult VolunteersPulmonary TuberculosisNCT01927159Access to Advanced Health Institute (AAHI)66
已完成
3 期
Efficacy and Safety of VPM1002 in Reducing SARS-CoV-2 (COVID-19) Infection Rate and SeveritySARS-CoV-2 InfectionNCT04439045University Health Network, Toronto122
已完成
不适用
Clinical Study to Evaluate Safety and Immunogenicity of Bacillus Calmette-Guerin (BCG) Delivery Via Novel Micronjet600 Device Compared to Those Via Conventional NeedleBCG VaccinationTuberculosisNCT04064554Yonsei University15
终止
2 期
A Study of an Ad26.RSV.preF-based Regimen in the Prevention of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV)-Mediated Lower Respiratory Tract Disease in Adults Aged 65 Years and OlderRespiratory Syncytial VirusesRespiratory Tract DiseasesNCT03982199Janssen Vaccines & Prevention B.V.5,815
进行中（未招募）
3 期
The Role of BCG Vaccine in the Clinical Evolution of COVID-19 and in the Efficacy of Anti-SARS-CoV-2 VaccinesCOVID-19NCT05507671Oswaldo Cruz Foundation556