Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06205589
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-01-04
Brief Title:
Therapeutic ID93 GLA-SE Vaccination in Participants With Rifampicin-Susceptible Pulmonary TB
Sponsor:
Advancing Clinical Therapeutics Globally for HIVAIDS and Other Infections
Organization:
Advancing Clinical Therapeutics Globally for HIVAIDS and Other Infections
Study Overview
Official Title:
A Phase 2a2b Study Evaluating Safety Immunogenicity and Therapeutic Efficacy of ID93 GLA-SE Vaccination in Participants With Rifampicin-Susceptible Pulmonary TB
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is being done to test an experimental study vaccine compared to a placebo The experimental study vaccine is called ID93 GLA-SE ID93 GLA-SE has been used in humans in research but has not been approved for use in medical care This study will be the first to test ID93 GLA-SE in people living with HIV PLWH The injections during the study will be given to different groups of participants while they are using standard TB treatment One of the research questions is to understand the differences in immune system responses depending on the timing of giving the injections after people begin taking standard TB treatment Researchers also want to continue to look at whether the study vaccine is safe when tested in a larger group of people and if getting the study vaccine in addition to standard TB treatment can help to lower the number of poor TB outcomes that people might have
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UM1AI068636 | NIH | None | httpsreporternihgovquickSearchUM1AI068636 |