A Study to Evaluate the Efficacy, Safety and Immunogenicity of MTBVAC in IGRA Positive Adolescents and Adults Living in a TB Endemic Region.

Tuberculosis (TB) Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

Phase 2b, double-blind, randomized, placebo-controlled, safety and efficacy study in 4,300 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 5x10^5 CFU. Participants meeting the enrolment criteria will be randomized in a 1:1 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 MTB/RIF 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06272812
Study type	Interventional
Source	International AIDS Vaccine Initiative
Contact	Elana Van Brakel, MD
Phone	27.21.344.1200
Email	evanbrakel@iavi.org
Status	Not yet recruiting
Phase	Phase 2
Start date	September 2024
Completion date	March 2028

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.