Vietnam begins clinical trials of ARCT-154 Covid-19 vaccine

The first phase of clinical trials of the ARCT-154 Covid-19 vaccine kicked off on August 15 at the Hanoi Medical University.

ARCT-154, the next generation STARR™ mRNA vaccine candidate targeting SARS-CoV-2 variants of concern, is jointly produced by VinBioCare, a member of property developer Vingroup and the US-based company Arcturus Therapeutics.

ARCT-154 is a two-dose self-amplifying mRNA vaccine to be produced under the collaboration of VinBioCare (a member of Vingroup, the largest private conglomerate in Vietnam) and Arcturus.

According to Professor Ta Thanh Van, chairman of the Council of Hanoi Medical University, the vaccine’s clinical trials will be carried out in three phases in Vietnam.

"The first trial phase will be conducted with 100 volunteers, while 300 and 20,600 people will participate in the second and third phases, respectively," Van said.

Deputy Minister of Health Tran Van Thuan and Chairman of the Council of Hanoi Medical University Ta Thanh Van witnessed the first test injection of ARCT-154 vaccine for a volunteer. Photo: Nam Tran

The first-phase volunteers began to receive the first shots at the university’s Clinical Testing Center today. Volunteers had to be healthy adults aged 18 to 59 and had no underlying medical conditions or history of SARS, MERS, or Covid-19. They are also required not to take any medications on a regular basis and who are not vaccinated against the novel coronavirus, Van noted.

According to Deputy Minister of Health Tran Van Thuan, ARCT-154 is the third Covid-19 vaccine undergoing human clinical trials in Vietnam and the first to be developed with mRNA technology under the instruction of the Vietnamese Government.

"I believe that the clinical trial of the ARCT-154 vaccine will soon be successful and Vietnam will soon become self-sufficient in the Covid-19 vaccine," said the deputy minister.

On August 2, Vietnam’s Ministry of Health approved the clinical trials of the ARCT-154 when it had entered clinical trials in the US, Singapore, and other countries.

Upon completion of the three-phase human clinical trial in Vietnam, Vinbiocare will submit the results to the ministry for approval for emergency use of the vaccine across the country in December. The first batch of vaccines is expected to be available in early 2022.

The first made-in-Vietnam Covid-19 vaccine tested on humans is Nano Covax, developed domestically by Nanogen Pharmaceutical Biotechnology JSC based on recombinant DNA/protein technology. The vaccine has gone through three phases of clinical trials with more than 13,620 volunteers. Results from the first two trial phases showed that all volunteers developed antibodies against the novel coronavirus.

The second vaccine candidate, Covivac, developed by the Institute of Vaccines and Medical Biologicals (IVAC), is expected to enter the third testing phase in September 2021.

The country is accelerating immunization to drive back the Covid-19 spread, with the number of people receiving the first and second shots exceeding 14 million and 1.4 million, the health ministry reported.

Vietnam has targeted to secure 150 million doses of vaccines to inoculate two-thirds of its 98-million population to reach herd immunity, the ministry said, adding that the country has so far obtained only over 20.5 million doses from different sources, including the COVAX Facility, contractual purchases, and donations.