Government Continues Dengue Vaccine Clinical Trial In Indonesia

UNSPLASH/Mufid Majnun ILLUSTRATION

JAKARTA - The government continues the process of clinical trials of dengue vaccines in order to minimize dengue infections and economic burdens in Indonesia.

"The V181-005 vaccine clinical trial has the potential to provide innovation to improve propriety and accelerate protection for children. BPOM has issued approval for this clinical trial in August 2025," said Head of the Food and Drug Supervisory Agency (BPOM) Taruna Ikrar as reported by ANTARA, Wednesday, December 3,

Advanced clinical trials for the development of dengue vaccines continued with data belonging to the World Health Organization (WHO) in 2024 recording more than 257,000 cases and 1,400 deaths due to dengue found in Indonesia. Meanwhile, a study found cases of dengue infection in Indonesia gave an economic burden of 381.15 million US dollars in 2015.

Therefore, RSUPN Dr Cipto Mangunkusumo and the Faculty of Medicine team of the University of Indonesia supported by the Ministry of Health, BPOM and MSD are working together to start further clinical trials for the development of dengue vaccines with age coverage starting from 2 years, and only requiring one dose.

The V181-005 Vaccine Clinical Trial aims to evaluate the safety, immunogenicity, and efficacy of dengue vaccines to provide more relevant and efficient protection to prevent dengue infection in the long term.

BPOM will oversee the implementation of this clinical trial through inspection of Good Clinical Trial Methods (CUKB). BPOM is also committed to supporting research on the development of drugs and raw materials for drugs, including vaccines through ABG collaboration, namely Academia, Business, and the government and overseeing the acceleration of downstreaming of research products and the availability and independence of national drugs to realize the nation's independence in the Indonesian health sector.

This clinical trial was led by Dr. dr. Mulya Rahma Karyanti, Sp.A(K), M.Sc., Ph.D who acted as the Main Researcher and went through a rigorous stage of research, starting from phases 1 and 2 on adult subjects to assess safety, determine doses and assess the immune response.

Currently clinical trials are entering phase 3 which will involve more than 10,000 healthy participants, including children aged 2'17, with a duration of five years and taking place in several countries.

At this stage, researchers assess the safety, immunogenicity, and efficacy of vaccines in the long term. The entire process is carried out in accordance with the CUKB and supervised by regulators and ethics committees to ensure data security and integrity.

"In the third phase in Indonesia, as many as 1,000 respondents will participate through a rigorous selection process, accompanied by consent (informed consent) from participants and parents, as well as ongoing medical monitoring," he said.

Furthermore, this clinical trial is a significant scientific step to obtain valid data on the safety, immune response, and efficacy of dengue vaccines.

Managing Director of MSD Indonesia George Stylianou said dengue infection is an increasing public health threat, and we are working with full urgency to advance clinical trials and innovations aimed at helping protect millions of people at risk of dengue infection.