Vietnam launches clinical trial program for ARCT-154 vaccine

Illustration photo: VNA

According to information from the Ministry of Health, on August 15, 2021, Hanoi Medical Universityiwill launch the phase 1 clinical trial program of the ARCT-154 Covid-19 vaccine for 100 volunteers from Hanoi.

Volunteers will receive two injections.

Professor Ta Thanh Van, principal researcher - Representative of Hanoi Medical University, said that the clinical trial injection process of the vaccine was carried out in accordance with the outline approved by the Ministry of Health on August 2, 2021.

Before the experimental injection, volunteers were screened and tested.

According to the clinical research protocol for the ARCT-154 vaccine approved by the Ministry of Health, phase 1 will be conducted on 100 healthy volunteers randomly assigned in a 3:1 ratio (75% ARCT-154 and 25% placebo) with the main objective of evaluating safety and immunogenicity.

Volunteers will receive two doses of ARCT-154 vaccine or placebo 28 days apart. Safety data from the first dose (day 1) to 7 days after the second dose (day 36) will be evaluated. If this data is assessed by the Ministry of Health's Ethics Council to show that the ARCT-154 vaccine is safe and well tolerated, permission will be sought from the regulatory agency to conduct phase 2 clinical trials early.

ARCT-154 is the first vaccine produced using mRNA technology in Vietnam, negotiated by VinBioCare Biotechnology Joint Stock Company under VinGroup Corporation to receive technology transfer from Arcturus Therapeutics, Inc, USA.

This vaccine is developed using advanced saRNA (self-amplifying mRNA) technology. This is a new technology that allows for lower vaccine doses while stimulating longer-lasting immunity, providing quick and simple prevention of nCoV variants, and is capable of fighting dangerous new variants such as Alpha, Beta, Delta, Gamma, etc.

The research will be carried out in 3 phases.

Following the direction of the Prime Minister and the Ministry of Health on transferring Covid-19 vaccine technology to soon have products to serve the epidemic prevention work, VinBioCare has purchased mRNA Covid-19 vaccine technology from Arcturus and invested in building a vaccine manufacturing plant in Hoa Lac High-Tech Park called ARCT-154.

On August 2, 2021, the Ministry of Health issued Decision No. 3679/QD-BYT approving the research outline for clinical trials of the ARCT-154 vaccine against Covid-19.

Identifying the development of domestic Covid-19 vaccines, including technology transfer vaccines, as an important task of the health sector at the present stage, the Ministry of Health's Special Task Force has held many meetings with Vingroup, transfer partner Arcturus, vaccine clinical trial units (Hanoi Medical University, Pasteur Institute of Ho Chi Minh City, Military Medical Academy), experts in the field of vaccine research, production and testing, and research support organizations.

The goal is to develop and unify the outline and documents for clinical trials in Vietnam. The study will be conducted in all three phases 1, 2, and 3 in Vietnam on volunteers aged 18 and over.

Phase 1: conducted at Hanoi Medical University on 100 volunteers.

Phase 2: conducted on 300 volunteers at trial organizations and in communities in the provinces where the research was carried out.

Phase 3: 20,600 subjects, including phase 3a (600 volunteers) and 3b (20,000 volunteers).

Phase 1 will start on August 15-16, 2021 with the first injection of ARCT-154 vaccine for 100 healthy volunteers at the Clinical Trial Center (Hanoi Medical University).