IGRA Epid Study
A multi-country, epidemiologic study to assess the interferon gamma release assay (IGRA) positivity, and to build capacity to conduct a tuberculosis (TB) vaccine efficacy study, in populations with a high TB disease burden
Background
MTB infection causing TB disease is one of the top 10 causes of death worldwide. The most effective contribution to controlling TB is vaccination. BCG is the only licensed vaccine; however, this vaccine does not provide substantial protection against pulmonary TB in adults infected with MTB. GlaxoSmithKline Biologicals, SA (GSK) has developed M72/AS01E, a TB vaccine candidate to protect against TB in adolescents and adults. The IGRA study will help refine the sample size and duration required for phase 3 studies.
Information
This study will be conducted to assess the proportion of IGRA positivity based on study location and to build capacity for conducting a pivotal phase 3 TB vaccine efficacy study.
The study will take place at 42 sites across 14 countries, including Indonesia, South Africa, Kenya, Gambia, Zambia, Uganda, Peru, Mozambique, Brazil, Congo, Vietnam, the Philippines, India, and Bangladesh.
The target number of participants is 8,000 worldwide, with 160 participants per site.
Type of Study
Observational Study
Topic
Tuberculosis
Collaborator
The Bill & Melinda Gates Medical Research Institute
