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
- To evaluate the immunogenicity of MTBVAC compared to BCG in all participants using PBMC
研究概览
简要总结
Phase II trial to establish the safety, reactogenicity, and immunogenicity of the MTBVAC with a licensed BCG vaccine as a comparator in both TB naïve (QFT PLUS negative) and TB exposed (QFT PLUS positive) healthy adults and adolescents.
详细描述
Phase II, double-blind, randomized, safety and immunogenicity trial with BCG vaccine as a comparator in 164 healthy adults and adolescents and with both positive and negative interferon gamma release assay (IGRA) test result.
Objective
To evaluate the immunogenicity of MTBVAC compared to BCG in all participants using PBMC 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. Only HIV-negative participants will be eligible for enrolment. 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 negative and QFT positive).
Cohort 1 will include 82 QFT Negative participants Cohort 2 will include 82 QFT Positive participants. Study participants will be randomized in a 1:1 ratio within each cohort to receive MTBVAC (Total N=82, includes 41 QFT negative & 41 QFT positive participants) or BCG (Total N=82, includes 41 QFT negative & 41 QFT positive participants) Participants will be followed up for safety and Immunogenicity following vaccination via regular visits.
At least 20% of the participants will be the adolescent population in each cohort in treatment and comparator arms.
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)
盲法说明
The trial participant, trial investigator, and sponsor will be blinded to the intervention given. The pharmacist will be unblinded staff in the trial and will not be the part of any other trial procedures or collection of safety information.
Test and control vaccines will be packed into identical white cartons with only kit numbers. On the day of dosing, the unblinded pharmacist at each trial site will be provided with the required participant information.The pharmacist will prepare and dispense the injection as per the randomization code(under physical partition for maintaining blinding) and provide the syringe to the trialnurse to administer the IP to the participant.The Data and Safety Monitoring Board (DSMB) will receive aggregate data for safetyreview. If necessary, data may be unblinded to individual participant treatment assignments to adequately assess safety issues.
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
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/assent.
- •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 three 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 three months.
- •No evidence of active TB disease during screening - As confirmed by normal chest radiograph and no sputum positivity by NAAT test for M. tb
- •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
- •11. Had BCG vaccination, documented through the presence of scar.
排除标准
- •Any chronic febrile illness with oral temperature > 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 three 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 allergic disease or reactions.
- •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 is 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.
- •Participants 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.
- •A family history of congenital or hereditary immunodeficiency
- •History of any neurologic disorders or seizures.
- •History of chronic alcohol consumption and/or drug abuse.
- •Congenital defects in the cardiopulmonary and neurological system
- •Pregnant or lactating female.
- •Females who are 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.
研究组 & 干预措施
MTBVAC
Biological: MTBVAC (BBV169) Mycobacterium tuberculosis vaccine
干预措施: MTBVAC (Biological)
BCG
Biological: BCG [TUBERVAC]
干预措施: BCG Sii (Biological)
结局指标
主要结局
To evaluate the immunogenicity of MTBVAC compared to BCG in all participants using PBMC
时间窗: Day 1 through Day 180
Antigen-specific CD4 response - Frequencies and co-expression patterns of CD4 cells expressing IFN-γ, and/or TNF, and/or IL-2, induced by MTBVAC and BCG measured on Day 0, 28, 56, 90 and 180 using PBMC Intracellular cytokine assay
次要结局
- To evaluate the safety and reactogenicity of MTBVAC compared to BCG- Immediate adverse events(30 minutes of vaccination)
- To evaluate the safety and reactogenicity of MTBVAC compared to BCG- Solicited adverse events(Day 1 through Day 14)
- To evaluate the safety and reactogenicity of MTBVAC compared to BCG- Injection site reactions(Day 1 through Day 90)
- To evaluate the safety and reactogenicity of MTBVAC compared to BCG- Unsolicited adverse events(Day 1 through Day 360)
- To evaluate the safety and reactogenicity of MTBVAC compared to BCG- Serious adverse events (SAE s)(Day 1 through Day 360)
- To evaluate the safety and reactogenicity of MTBVAC compared to BCG- AESI (Adverse Event of Special Interest)(Day 1 through Day 360)