Ministry Of Health Recruits 2,095 M72 Vaccine Clinical Trial Participants

ILLUSTRATION BETWEEN

JAKARTA - The Ministry of Health has recruited 2,095 participants for phase 3 clinical trials of M72 Tuberculosis (TBC) vaccine candidates, from youth and adult groups as part of the global study which is also held in South Africa, Kenya, Zambia and Malawi.

Head of the Communication and Public Information Bureau of the Ministry of Health, Aji Muhawarman, said that this clinical trial aims to evaluate the safety and effectiveness of the M72 vaccine in preventing pulmonary tuberculosis in adult individuals with latent TB infections who are not infected with HIV.

"This vaccine mandate has been developed since the beginning of 2000 and shows good safety profiles in previous studies," said Aji as quoted by ANTARA, Thursday, May 8.

The total participants in phase 3 clinical trials, he said, amounted to 20,081 people from five countries. South Africa became the largest contributor to 13,071 participants, followed by Kenya (3,579), Indonesia (2,095), Zambia (889), and Malawi (447).

In Indonesia, he continued, this activity was carried out in various leading medical institutions, including the Faculty of Medicine, University of Indonesia (FKUI), RS University of Indonesia (RSUI), Friendship Hospital, Cempaka Putih Islamic Hospital in Jakarta, and Padjadjaran University of Medicine Faculty (FK UNPAD) in Bandung.

The implementation of clinical trials began on September 3, 2024, and the recruitment of participants has officially been completed as of April 16, 2025.

To date, said Aji, there are about 15 TB vaccine candidates being developed globally, including M72 which has reached phase 3, namely the last stage before the vaccine can be widely used.

The development of this vaccine is supported by the Gates Foundation, he said, and it is hoped that the entire series of clinical trials will be completed by the end of 2028.

"Clinical trials are a crucial stage in the vaccine development process to ensure safety, effectiveness, and identify potential side effects before being used by the community," he said.

The vaccine clinical trial process is carried out in stages, starting from pre-clinical testing in animals, then phase 1 in a small number of human participants (2050 people), phase 2 in larger groups (200300 people), to phase 3 involving tens of thousands of cross-border participants.

Phase 3, he said, was the main basis in the regulatory evaluation process before the vaccine received a distribution permit.

He said that all M72 vaccine clinical trials in Indonesia were closely monitored by the World Health Organization (WHO), the Food and Drug Supervisory Agency (BPOM), the Ministry of Health, as well as national and global TB vaccine experts.

Aji assessed that Indonesia's involvement in this research reflects a strong commitment to supporting the global efforts to eradicate TB, an infectious disease that is still one of the highest causes of death in the world.