The Hanoi Medical University will start on August 15 Phase 1 of clinical trial of the mRNA COVID-19 vaccine named ARCT-154 vaccine with 100 volunteers from Hanoi. (Photo: VNA) Hanoi (VNA) – The Hanoi Medical University will start on August 15 Phase 1 of clinical trial of the mRNA COVID-19 vaccine named ARCT-154 vaccine with 100 volunteers from Hanoi.
The self-amplifying mRNA vaccine is developed by the US-based Arcturus Therapeutics who partners with VinGroup's VinBioCare for support in clinical trials and manufacturing (at a facility in Hoa Lạc Hi-tech Park, Hanoi).
Volunteers to get two shots
According to Professor Ta Thanh Van, chief researcher and representative from the Hanoi Medical University, the clinical trials will be conducted in line with a research project approved by the Ministry of Health on August 2, 2021.
Before the injection, volunteers will undergo screen tests and other medical checks-up.
"When testing the Covivac vaccine, the research team had to rely on the press to publish information about recruiting volunteers widely for several days to have enough people. But for the ARCT-154 vaccine, after only two days announcing the recruitment of volunteers, we received more than 800 people. Through screening, more than 100 qualified people have been selected,” he said.
According to the project, the first phase will be carried out on 100 healthy volunteers randomly assigned in a ratio of 3:1 (75 percent to get ARCT-154 and 25 percent to get placebo), aiming to evaluate the safety and immunogenicity of the vaccine.
Volunteers will receive two doses of ARCT-154 vaccine or a placebo 28 days apart. Safety data from the first dose (Day 1) until the seventh day after the second shot (Day 36) will be evaluated.
If the health ministry’s Ethics Committee confirms the safety and tolerability of ARCT-154 vaccine, further procedures will be carried out to seek permission from management agencies for Phase 2.
COVID-19 vaccines using Arcturus' mRNA technology have been under Phases 1, 2 and 3 of clinical trials in the US, Singapore and many other countries around the world.
The technology allows a lower dose of vaccine, while the immune stimulation lasts longer, for a quick and simple prevention of the COVID-19, and is capable of fighting dangerous new variants of coronavirus such as Alpha, Beta, Delta and Gamma.
Three-phase trials
The clinical trials will be carried out in three phases with the participation of 21,000 volunteers, including 100 in Phase 1, 300 in Phase 2, and 20,600 in Phase 3.
On August 2, the MoH approved a proposal on human clinical trials of the ARCT-154 vaccine. The vaccine's production technology was bought by VinBioCare Biotechnology JSC, a subsidy of Vietnam's leading multisectoral conglomerate Vingroup.
VinBioCare has begun the construction of a vaccine production facility in Hanoi’s Hoa Lac Hi-Tech Park with a total investment of more than 200 million USD. The facility has a designed capacity of 200 million doses per year.
The installation of equipment for the facility is expected to be completed in November.
After completing the three-phase human clinical trial, VinBioCare 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 put into human clinical trials in Vietnam and the first developed with mRNA technology.
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, developed by the Institute of Vaccines and Medical Biologicals (IVAC), is expected to enter Phase 3 in September 2021./.
