Advances In Indonesian-made Tuberculosis Vaccine Entering Phase 3 Clinical Trials

Illustration of tuberculosis (Freepik) vaccine

JAKARTA - Progress in the development of the Tuberculosis (TB) vaccine continues to show positive developments. One of the vaccines being investigated is the TB M72/AS01E vaccine, which is expected to provide protection for adolescents and adults from this disease.

National Researcher for Vaccines TB, Prof. Dr. dr. Erlina Burhan, Sp.P(K), revealed that Indonesia is currently undergoing phase three clinical trials for the TB M72 vaccine after previously successfully going through phase 2B clinical trials with an efficacy level of 50 percent.

"The phase 3 clinical trial is ongoing, and we hope that recruitment will be completed in early April. Furthermore, participants will be monitored for the next three years, so that the results can be known in 2028. Hopefully, this vaccine can be produced in parallel and available at the end of 2028," said dr. Erlina in an online meeting with the media in Jakarta.

The TB M72/AS01E vaccine has great potential in reducing cases of Tuberculosis among adolescents and adults, especially considering that the BCG vaccine that has been used for more than a century is only effective in infants.

The presence of this vaccine is a new hope in an effort to overcome the spread of Mycobacterium tuberculosis which is the cause of TB.

According to a Global Tuberculosis Report 2024 report from the World Health Organization (WHO), global TB cases in 2023 reached 10.8 million, with Indonesia being ranked second highest. In the same year, Indonesia recorded 1.09.000 TB cases with a death toll of 130,000 people, accounting for about 10 percent of the total global cases.

Research into the TB M72/AS01E vaccine is expected to provide better results in phase three clinical trials. "In phase 2, the efficacy reaches 50-54 percent. We hope that in phase 3, with a larger number of participants, the efficacy can increase higher. According to WHO standards, vaccines with efficacy above 50 percent are eligible for use," explained dr. Erlina.

Indonesia was involved in the global research of the TB M72/AS01E vaccine along with four other countries, namely South Africa, Kenya, Zambia, and Malawi. Since the end of 2022, Indonesia has started to participate in this study, which was then followed by the finalization of protocols and submission of research locations in 2023. Of the 10 proposed locations, five research locations were approved, namely:

Faculty Of Medicine, University Of Indonesia

Faculty Of Medicine, Padjadjaran University

Friendship Center General Hospital

University of Indonesia Hospital

Jakarta Islamic Hospital Cempaka Putih

After going through various administrative stages, including approval from the Ethics and Licensing Committee from BPOM, research finally got the green light in mid-2024. From September 2024 to March 6, 2025, the research team has recruited 1,839 participants, who are currently still under monitoring.

In this clinical trial, participants received two doses of the vaccine at an interval of one month. They are also given information about possible post-immunization side effects (KIPI), such as pain at the injection site, fever, headache, or itching. Light side effects that appear, such as fever and pain, can be treated with simple drugs or ice compresses.

While waiting for the final results of the clinical trial of the TB M72/AS01E vaccine, dr. Erlina invites the public to continue to apply a healthy lifestyle to prevent transmission of TB.

"We have to optimize existing prevention strategies, while waiting for this vaccine to be available in 2028," he concluded.