Information

The study is conducted across five countries: Indonesia, Kenya, Malawi, Mozambique, and South Africa, with each country contributing to the generation of robust evidence for TB vaccine development. In Indonesia, five clinical sites are participating in the trial, with RPRI supporting operational implementation at three hospitals: RSUP Persahabatan, RS Universitas Indonesia, and RSIJ Cempaka Putih. As a high TB burden country, Indonesia plays an important role in assessing the potential public health impact of a future TB vaccine.

The study uses a randomized, double-blind, placebo-controlled design to evaluate whether the investigational M72/AS01E vaccine can prevent pulmonary tuberculosis in adolescents and adults aged 15 to 44 years who are at risk of TB infection or disease. Participants receive two injections one month apart and are followed for several years to assess vaccine efficacy, safety, and immunogenicity. Key assessments include monitoring for laboratory-confirmed pulmonary TB, evaluating antibody responses to the vaccine antigen, and documenting adverse events and serious adverse events throughout the study period.

• Gates Medical Research Institute (Gates MRI) - sponsor

• IQVIA - CRO

• RPRI - SMO

• RS Persahabatan

• RS Universitas Indonesia

• RSIJ Cempaka Putih

Type of Study

Stakeholders Involved

TB Vaccine Study

Background

Tuberculosis remains one of the leading infectious causes of death worldwide, and Indonesia continues to be among the countries with the highest number of TB cases each year. Current tools for TB prevention have important limitations, especially for adolescents and adults who carry the greatest burden of transmission. The M72/AS01E vaccine candidate demonstrated promising protective effects in an earlier Phase 2 trial. The ongoing Phase 3 study aims to determine whether the vaccine can provide reliable and reproducible protection against pulmonary TB in diverse populations and high-burden settings.

Indonesia’s participation in this global study reflects the importance of generating evidence in real-world, high-incidence contexts. Through collaboration with international research organizations and leading clinical centers in Indonesia, the trial contributes to the global effort to develop a more effective TB vaccine for adolescents and adults.

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