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Health Ministry approves research protocol for clinical trial of ARCT-154 vaccine

by NDO03 August 2021 Last updated at 10:35 AM

The ARCT-154 Phase 1/2/3 clinical study will be implemented in Vietnam with the participation of about 21,000 volunteers aged 18 or above. (Illustrative image)
The ARCT-154 Phase 1/2/3 clinical study will be implemented in Vietnam with the participation of about 21,000 volunteers aged 18 or above. (Illustrative image)

The Ministry of Health (MOH) issued Decision No. 3679/QD-BYT on August 2, approving a research protocol for a clinical trial of mRNA-based COVID-19 vaccine candidate ARCT-154, transferred from the United States’ Arcturus Therapeutics Holdings Inc.

Under the direction of the Prime Minister and MOH leaders on promoting vaccine technology transfer in order to soon have products for pandemic prevention and control, Vingroup, through its subsidiary VinBioCare, has approached and negotiated with Arcturus on the purchase of the COVID-19 mRNA vaccine technology, and will construct a factory to manufacture the aforementioned vaccine at the Hoa Lac Hi-tech Park in suburban Hanoi.

Determining the domestic development of COVID-19 vaccines, including vaccines through technology transfer, as an important task of the health sector in the current period, the MOH’s special working group has held meetings with Vingroup; its transfer partner Arcturus; vaccine clinical trial units including the Hanoi Medical University, Pasteur Institute in Ho Chi Minh City, and Vietnam Military Medical Academy; experts in the field of vaccine research, production and testing; and research support organisations to design and agree on the research protocol and record for a clinical trial in Vietnam.

Accordingly, the ARCT-154 Phase 1/2/3 clinical study will be implemented in the Southeast Asian country with the participation of about 21,000 volunteers aged 18 or above.

Phase 1 will be carried out at the Hanoi Medical University with more than 100 volunteers, while Phase 2 features over 300 participants at trial organisations and from the community in the provinces implementing the research. Phase 3 will go ahead with 20,600 volunteers, comprising Phase 3a (600 volunteers) and Phase 3b (20,000).

According to the plan, the ARCT-154 COVID-19 vaccine clinical trial programme will be kick-started at the Hanoi Medical University on August 8.

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