A Phase 2a Clinical Trial to Evaluate the Safety and Immunogenicity of MTBVAC

HIV Vaccine Trials Network16 个研究点分布在 1 个国家目标入组 276 人2024年1月30日

适应症HIV I Infection Tuberculosis

干预措施MTBVAC BCG

概览

阶段: 2 期
干预措施: MTBVAC
疾病 / 适应症: HIV I Infection
发起方: HIV Vaccine Trials Network
入组人数: 276
试验地点: 16
主要终点: Number of unsolicited adverse events
状态: 招募中
最后更新: 上个月

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

The purpose of this study is to evaluate the safety and immunogenicity of MTBVAC in adolescents and adults living with and without HIV in South Africa

详细描述

This study will evaluate the safety and immunogenicity of MTBVAC in adolescents and adults living with and without HIV in South Africa. The study will be conducted in two parts (Part A and B). Part A will include two Cohorts (Cohort 1 and 2) and each Cohort will have four groups. Part B will have one Cohort which will also have four groups. Participants will be recruited into three cohorts (Cohorts 1-3) based on their HIV status and, for People Living With HIV, their CD4+ T cell count and WHO clinical stage prior to ART initiation/re-initiation. Within each cohort, they will be stratified into subgroups based on their IGRA status. For Cohorts 1 and 2 which will enroll simultaneously, participants will be randomized to receive MTBVAC or BCG according to the ratio of the planned sample sizes within the cohort; there is no placebo group in this trial. Enrollment of Cohort 3 will proceed if safety criteria are met for Cohorts 1 and 2, with randomization to MTBVAC and BCG. Participants in all groups will receive a single ID study product injection of 0.1 mL in volume and will be followed for 48 weeks.

注册库

clinicaltrials.gov

开始日期

2024年1月30日

结束日期

2027年4月5日

最后更新

上个月

研究类型

Interventional

研究设计

Sequential

性别

All

研究者

发起方

HIV Vaccine Trials Network

责任方

Sponsor

入排标准

入选标准

•Age of 12 through 55 years, on the day of enrollment.
•Access to a participating HVTN or ACTG CRS and willingness to be followed for the planned duration of the study.
•For volunteers 18 years of age or older: ability and willingness to provide informed consent.
•For volunteers less than 18 years of age: parent or legal guardian is willing and able to provide informed consent for potential participant's study participation; in addition, when applicable per ethics committee policies and procedures, potential participant is willing and able to provide written assent for study participation.
•Assessment of Understanding (AoU): volunteer demonstrates understanding of this study and completes a questionnaire prior to vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly.
•Prior receipt of BCG vaccine in infancy as determined by the site investigator.
•Agrees not to enroll in another study of an investigational study product until after the last scheduled clinic visit. If a potential participant is already enrolled in another clinical trial, approvals from the other trial sponsor and the HVTN 605/A5421 PSRT are required prior to enrollment into HVTN 605/A
•Good general health as shown by medical history, physical exam, and screening laboratory tests and assessed by the site investigator.
•Willingness to receive HIV-related test results.
•For volunteers living without HIV:

排除标准

•Weight less than 40 kg
•Known significant exposure to TB or receipt of tuberculin skin test in the six months prior enrollment, as determined by the site investigator based on potential participant/parent/guardian report and available medical records. \[Note: Significant exposure is defined as close contact with a person who has active TB and has not completed TB treatment. Close contact is defined as sleeping in the same contiguous house/dwelling, and/or working or socializing in close proximity in an enclosed space frequently (eg, several times a week).\]
•History of prior active TB disease, as determined by the site investigator based on participant/parent/guardian report and available medical, laboratory or radiographic records.
•Evidence of active TB disease as determined by the site investigator based on participant/parent/guardian report and available medical records, results from physical examination, two-view chest X-ray, and M.tb nucleic acid testing from an expectorated sputum, including a review of any available radiography; and, for volunteers living with HIV and a CD4 count \<200 cells/mm3, a positive urine LAM test.
•Receipt of TB preventive therapy within 28 days prior to enrollment or expected to initiate TB preventive therapy during the study as determined by the site investigator based on participant/parent/guardian report and available medical records Note: Clinical indication for receipt of TB preventive therapy will be determined by the site investigator consistent with local standard guidelines. Potential participants on TB preventive therapy during screening may be enrolled once the exclusionary timeframes indicated above have elapsed. If the screening period is exceeded while this requirement is being met, a new screening attempt should be initiated.
•For volunteers living with HIV: current active AIDS-defining condition as determined by the site investigator based on participant/parent/guardian report and available medical records
•Blood products received within 120 days before vaccination.
•Investigational study products (non-vaccine) received within 28 days before vaccination.
•Pregnant or breastfeeding.
•Investigational TB vaccine(s) received in a prior TB vaccine trial or BCG vaccination outside infancy. For volunteers who have received control/placebo in a TB vaccine trial, the HVTN 605/A5421 PSRT will determine eligibility on a case-by-case basis.

研究组 & 干预措施

1.1a - Adolescents and adults without HIV and negative interferon-gamma release assay

Participants will receive MTBVAC as a 0.1 mL intradermal (ID) injection, in the upper arm once at Week 0.

干预措施: MTBVAC