Phase I Open Label BCG Clinical Trial Assessing TB Drugs and Vaccines (NCT05592223) | Clinical Trial Compass
CompletedPhase 1
Phase I Open Label BCG Clinical Trial Assessing TB Drugs and Vaccines
United States20 participantsStarted 2022-12-06
Plain-language summary
The purpose of the study is to develop a BCG challenge model for use in short term Phase I human trials capable of assessing the ability of TB drugs and/or vaccine-induced immune responses to impact in vivo mycobacterial replication as a method of assessing antimycobacterial agents and/or protective immunity elicited by vaccines or host-directed therapy. The trial will illuminate the nature of local and systemic immune responses to BCG and treatment response, as well as demonstrate our local capacity for newer, more innovative study designs.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion Criteria:
* Provide written informed consent prior to initiation of any study procedures,
* Are males or non-pregnant females between the ages of 18 and 45 years, inclusive,
* Women of childbearing potential in sexual relationships with men must use an acceptable method of preventing conception from 30 days prior to 3 months after Tice® BCG administration. Not sterilized via tubal ligation, bilateral oophorectomy, hysterectomy or successful device placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or \< 1 year of the last menses if menopausal). Includes but is not limited to, sexual abstinence, monogamous relationship with vasectomized partner who has been vasectomized for 6 months or more prior to the subject receiving Tice® BCG, barrier methods such as condoms or diaphragms with spermicide or foam, effective intrauterine devices, NuvaRing ®, and licensed hormonal methods such as implants, injectables or oral contraceptives ("the pill").
* For women of childbearing potential, negative serum pregnancy test at screening and negative urine pregnancy test within 24 hours prior to enrollment and Tice® BCG administration,
* Are in good health, as judged by the investigator and determined by vital signs (oral temperature, pulse, and blood pressure), medical history and physical examination,
* Have a negative HIV-1 ELISA test,
* Have negative serology t…
What they're measuring
1
Assess Viable BCG Bacteria From Intradermal Challenge Site From Culture.