|ARTC-154, the third home-made vaccine against COVID-19 will start human clinical trials on August 15. Photo ncov.moh.gov.vn|
HÀ NỘI – Việt Nam is going to start clinical trials of the ARCT-154 vaccine, the third home-made vaccine against COVID-19, on August 15, the Ministry of Health has announced.
Nguyễn Ngô Quang, Deputy Director of the ministry’s Department of Science, Technology and Training, said that the trial unit started to recruit adult volunteers for clinical trials of ARCT-154 vaccine.
People between 18-59, without underlying illnesses and not taking regular medication, not infected with severe respiratory illnesses such as SARS, MERS, SARS-CoV-2 and have not been vaccinated against COVID-19 can register to be volunteers for the trials.
Volunteers are required to commit to follow the study's procedures and perform at least eight clinical visits according to the study schedules at the Centre for Clinical Pharmacology in Hà Nội Medical University.
Volunteers can sign up in three ways, including via telephone numbers of consultants, email firstname.lastname@example.org or the website: https://duoclylamsang.vn.
As many as 100 volunteers are needed.
According to the ministry, ARCT-154 is a self-amplifying mRNA vaccine designed to act against SARS-CoV-2 variants, including the Delta variant.
The clinical trials will be carried out in three phases with the participation of 21,000 volunteers, including more than 100 in phase one, 300 in phase two and 20,600 in phase three.
Previously, on August 2, the ministry approved a proposal on clinical trials of the ARCT-154 vaccine. The vaccine was purchased with technology transferred to VinBioCare Biotechnology JSC, a unit of Việt Nam's leading multisectoral conglomerate Vingroup, from Arcturus Therapeutics Holding Incorporation, USA.
This is a vaccine developed on mRNA technology to prevent COVID-19.
VinBioCare has invested in building a vaccine factory in Hòa Lạc Hi-Tech Park in Hà Nội with total investment capital of more than US$200 million and a capacity of 200 million doses per year.
The installation of equipment for the factory is expected to be completed in November.
After completing the three-phase clinical trials, the unit said it would send the results to the ministry for approval for emergency use across the country in December. The first batch of vaccines is expected to be available in early 2022.
ARCT-154 is the third COVID-19 vaccine to be put into clinical trials in Việt Nam.
The first COVID-19 vaccine tested on humans is Nanocovax, a product of Nanogen Pharmaceutical Biotechnology JSC based on recombinant DNA/protein technology. The vaccine has gone through three phases of the clinical trials with more than 13,620 volunteers. Results from the first two trial phases showed that all volunteers developed antibodies against SARS-CoV-2.
The second vaccine, Covivac, from the Institute of Vaccines and Medical Biologicals (IVAC), is expected to enter phase three in September 2021. VNS