Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06272812
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-22
First Post:
2024-02-09
Brief Title:
A Study to Evaluate the Efficacy Safety and Immunogenicity of MTBVAC in IGRA Positive Adolescents and Adults Living in a TB Endemic Region
Sponsor:
International AIDS Vaccine Initiative
Organization:
International AIDS Vaccine Initiative
Study Overview
Official Title:
A Phase 2b Double-blind Randomized Placebo-controlled Study to Evaluate the Efficacy Safety and Immunogenicity of a Candidate Tuberculosis TB Vaccine MTBVAC Against TB Disease in Interferon Gamma Release Assay Positive Adolescents and Adults Aged 14-45 Years Living in a TB Endemic Region
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
A Phase 2b double-blind randomized placebo-controlled study to evaluate the efficacy safety and immunogenicity of a candidate tuberculosis TB vaccine MTBVAC against TB disease in interferon gamma release assay positive adolescents and adults aged 14-45 years living in a TB endemic region
Detailed Description:
Phase 2b double-blind randomized placebo-controlled safety and efficacy study in 4300 healthy adults and with a positive interferon gamma release assay IGRA test result Most participants are likely to have received previous BCG vaccination in infancy The investigational product is MTBVAC administered intradermally at 5x105 CFU
Participants meeting the enrolment criteria will be randomized in a 11 ratio to receive a single dose of MTBVAC or placebo administered intradermally on Study Day 1
Participants will be followed up for efficacy following vaccination via regular visits and contacts to screen for possible TB Participants will also be trained to recognize signs and symptoms consistent with pulmonary TB disease and to report them for clinical evaluation Participants with clinical presumption of pulmonary TB will be assessed with confirmatory diagnostic testing using a Nucleic Acid Amplification Test Xpert MTBRIF Ultra assay and microbiological culture in sputum sampled on 3 separate days within a 1-week period Participants diagnosed with pulmonary TB will be referred for TB treatment according to local clinical practice
Only HIV-negative participants will be eligible for enrolment Participants will be tested for HIV seroconversion at the end of each year of follow-up and at the presumptive TB visits Participants who test positive for HIV will be referred for TB preventive treatment and antiretroviral treatment according to local clinical practice
A sub-cohort of approximately 640 participants 320 in each study arm will be selected for follow-up for solicited adverse events AE and selected chemistry and complete blood count CBC Additionally a sub-cohort of approximately 430 participants 215 in each study arm will be selected for specific immunogenicity assessments The strategy for participant sub-cohort selection will be described in the Study Operations Manual SOM
Participants meeting the enrolment criteria will be randomized in a 11 ratio to receive a single dose of MTBVAC or placebo administered intradermally on Study Day 1
Participants will be followed up for efficacy following vaccination via regular visits and contacts to screen for possible TB Participants will also be trained to recognize signs and symptoms consistent with pulmonary TB disease and to report them for clinical evaluation Participants with clinical presumption of pulmonary TB will be assessed with confirmatory diagnostic testing using a Nucleic Acid Amplification Test Xpert MTBRIF Ultra assay and microbiological culture in sputum sampled on 3 separate days within a 1-week period Participants diagnosed with pulmonary TB will be referred for TB treatment according to local clinical practice
Only HIV-negative participants will be eligible for enrolment Participants will be tested for HIV seroconversion at the end of each year of follow-up and at the presumptive TB visits Participants who test positive for HIV will be referred for TB preventive treatment and antiretroviral treatment according to local clinical practice
A sub-cohort of approximately 640 participants 320 in each study arm will be selected for follow-up for solicited adverse events AE and selected chemistry and complete blood count CBC Additionally a sub-cohort of approximately 430 participants 215 in each study arm will be selected for specific immunogenicity assessments The strategy for participant sub-cohort selection will be described in the Study Operations Manual SOM
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?:
None
Is an FDA AA801 Violation?:
None