ARCT-154-01: Demonstrating Vingroup’s Clinical Trial Implementation and Management Capabilities
April 10, 2026
In 2021, as the COVID-19 pandemic remained highly complex and vaccine supplies were limited, Vingroup responded to the call of the Prime Minister and the Ministry of Health by rapidly initiating clinical trials of a COVID-19 vaccine to help protect public health (1). As the sponsor, Vinbiocare Biotechnology Joint Stock Company (a subsidiary of Vingroup) conducted the clinical trial of the self-amplifying mRNA (sa-mRNA) vaccine ARCT-154 in Vietnam. The ARCT-154-01 study quickly became one of the largest and most complex clinical trials ever conducted in the country. The implementation and management of the study by the Vinmec Healthcare System clearly demonstrated its ability to conduct clinical trials to international standards, even under the urgent conditions of the pandemic. This trial not only made a significant contribution to the development of next-generation sa-mRNA vaccines but also marked a major advancement in Vietnam’s clinical research landscape. The results reflect the strong expertise of the research teams and reaffirm Vingroup’s commitment to sustained investment in healthcare science—undertaking critical studies for the benefit of the community while elevating Vietnam’s position on the global research map.
Trial Coordination and Management Capacity
To realize this objective, Vingroup mobilized extensive human, technical, and financial resources, implementing a multi-center study design tailored to Vietnam’s epidemiological context. Notably, clinical trial experts from Vinmec-VinUni played a central role in coordinating, monitoring, and managing the entire research process.
The study was conducted in full compliance with international ICH-GCP standards, strictly adhering to current regulations and under close oversight by the Ethics Committee and the Ministry of Health.
Rapid Implementation at National Scale
The ARCT-154-01 trial was designed as a seamless Phase 1/2/3 study and conducted simultaneously across 17 medical institutions nationwide, with three key partners: Hanoi Medical University, Pasteur Institute in Ho Chi Minh City, and the Vietnam Military Medical University. Phase 1 was initiated just days after receiving approval from the Ministry of Health on August 2, 2021 (1).
A thorough health screening was conducted for volunteers before the vaccine trial began to ensure safety (Source: Báo Nhân dân)
Within less than three months, more than 19,000 volunteers were screened and enrolled across five study phases. The participant retention rate reached 88.9% (2), reflecting strong operational capabilities in trial management, with a firm commitment to safety, quality, and strict adherence to scientific and ethical standards.
Safety, Transparency, and Compliance
Volunteers were followed for one year after the second dose to comprehensively capture safety data (3). Preliminary results indicate that the vaccine was well tolerated, with mostly mild to moderate adverse reactions, while demonstrating robust immunogenicity and high efficacy in preventing severe COVID-19 (3).
Through close collaboration between the sponsor and study sites, the trial dossier successfully passed evaluations and inspections by the Japan Pharmaceuticals and Medical Devices Agency (PMDA) in August 2023 at Yen Phong Medical Center, Bac Ninh (4,5).
In June 2025, the Ministry of Health formally accepted the final study report and issued Certificate No. 31/CN-K2ĐT, confirming the safety and efficacy of the two-dose ARCT-154 regimen in adults aged 18 years and older.
Contributing to International Approval
Clinical data generated from Vietnam were transparently published in international journals and directly contributed to the regulatory submissions for ARCT-154 (trade name: Kostaive®). This led to its approval as the first self-amplifying mRNA (sa-mRNA) COVID-19 vaccine in Japan (November 2023) and the European Union (February 2025) (6,7).
The success of the ARCT-154-01 trial not only underscores the potential of self-amplifying mRNA vaccine technology, but also stands as a clear testament to Vingroup’s capability—particularly Vinmec and VinUni—in conducting large-scale, high quality clinical trials that meet international standards.
REFERENCES
- Thông Tin Báo Chí: Khởi động Chương Trình thử nghiệm Lâm Sàng Vắc Xin arct-154 Theo Công Nghệ mRNA – hoạt động CỦA địa phương (2021) Cổng thông tin Bộ Y tế. Available at: https://moh.gov.vn/hoat-dong-cua-dia-phuong/-/asset_publisher/gHbla8vOQDuS/content/thong-tin-bao-chi-khoi-ong-chuong-trinh-thu-nghiem-lam-sang-vac-xin-arct-154-theo-cong-nghe-mrna
- The ARCT-154 Self-Amplifying RNA Vaccine Efficacy Study (ARCT-154-01) (ARCT-154-01) (2021) Clinicaltrials.gov. Available at: https://clinicaltrials.gov/study/NCT05012943?a=11.
- Hồ NT, H. S. T. V. P. L. Đ. Q. N. T. P. A. T. N. Đ. M. N. L. T. Q. P. H. C. M. N. T. L. Q. T. L. V. N. T. T. L. T. V. L. A. N. A. N. N. V. H. E. J. P. S. S. B. S., 2024. Safety, immunogenicity and efficacy of the self-amplifying mRNA ARCT-154 COVID-19 vaccine: pooled phase 1, 2, 3a and 3b randomized, controlled trials. Nature Communications.
- PMDA Nhật Bản đánh Giá Cao Thử Nghiệm Lâm Sàng Vắc Xin ARCT-154 (2024) Trung tâm Dược lý lâm sàng – ĐH Y Hà Nội . Available at: https://duoclylamsang.vn/pmda-nhat-ban-danh-gia-cao-thu-nghiem-lam-sang-vac-xin-arct-154.
- Thử nghiệm Lâm Sàng Vắc Xin ARCT-154 (2024) Trung tâm Dược lý lâm sàng – ĐH Y Hà Nội . Available at: https://duoclylamsang.vn/thu-nghiem-lam-sang-vac-xin-arct-154.
- Arcturus, 2023. Japan’s Ministry of Health, Labour and Welfare Approves CSL and Arcturus Therapeutics’ ARCT-154, the First Self-Amplifying mRNA Vaccine Approved for COVID in Adults. [Online]
Available at: https://ir.arcturusrx.com/news-releases/news-release-details/japans-ministry-health-labour-and-welfare-approves-csl-and - Arcturus, 2025. European Commission Approves CSL and Arcturus Therapeutics’ KOSTAIVE®, the First Self-amplifying mRNA COVID-19 Vaccine. [Online]
Available at: https://ir.arcturusrx.com/news-releases/news-release-details/european-commission-approves-csl-and-arcturus-therapeutics
