Vietnam to test ARCT-154 vaccine on volunteers
ARCT-154 is the third Covid-19 vaccine that has been approved for human clinical trials in Vietnam.
Hanoi Medical University is recruiting volunteers for the first phase of a clinical trial of the ARCT-154 vaccines, manufactured based on technology transferred by an American company.
The Ministry of Health made the announcement on August 9 after approving a proposal on human clinical trials of the vaccine by VinBioCare, an affiliate of Vingroup, a leading multisectoral conglomerate of Vietnam.
The testing will be carried out in three phases on adult volunteers at Hanoi Medical University, Ho Chi Minh City Pasteur Institute, and Vietnam Military Medical University. It aims to assess the safety, immunogenicity, and efficacy of the SARS-CoV-2 self-amplifying mRNA vaccine and will enroll up to 21,000 participants across the three phases.
It is expected that from August 15, the ARCT-154 vaccine's first phase of clinical trials will begin with 100 volunteers, conducted at Hanoi Medical University.
Currently, the university has started to recruit healthy volunteers, aged 15-59 years, with no history of SARS, MERS, or SARS-CoV-2 infections.
Besides, volunteers in the first phase must agree to follow the study's procedures and perform at least eight clinical visits in accordance with the study schedule at the Center for Clinical Pharmacology under Hanoi Medical University.
Vietnam to test the US ARCT-154 vaccines on volunteers. Photo: The Ministry of Health
The second phase will be conducted with over 300 volunteers from registered organizations and the community. The third phase will test on 20,600 volunteers.
Earlier, VinBioCare and the US-based Arcturus Therapeutics Holdings Inc. entered a partnership in early August to establish a manufacturing facility in Vietnam for the manufacture of Arcturus’ investigational Covid-19 vaccines, for sale and use within Vietnam.
Vingroup will invest more than US$200 million in the facility in Hanoi-based Hoa Lac Hi-Teck Park, which is designed to produce 200 million doses of the vaccine per year, with the first batch set to be rolled out in early 2022.
The ARCT-154 vaccine uses the latest mRNA technology, which has been improved to be able to fight Delta variable.
ARCT-154 is the third Covid-19 vaccine that has been approved for human clinical trials in Vietnam, after Nanocovax of Nanogen company and Covivac of IVAC.
The first vaccine candidate, Nano Covax, is entering the third phase of the trials, and the second candidate, Covivac, is in the second phase.
Nanogen that develops Nano Covax, has proposed the Ministry of Health approve its vaccine for emergency use in Vietnam following initial evaluation reports that show the vaccine is approximately 90% effective against the SARS-CoV-2 virus.
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