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2021-08-17| Asia-PacificCOVID-19

Vietnam Starts the Country’s First mRNA COVID-19 Human Trial

by Tyler Chen
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Vietnam begins the country’s first mRNA COVID-19 vaccine human trial with ARCT-154, the vaccine developed by the US biotech Arcturus Therapeutics. ARCT-154 is designed to target the WHO-listed Variant of Concern (VOC) of the COVID-19 virus.

 

Positive Preclinical Data Against the Delta Variant

Preclinical data have shown that in non-human primates, ARCT-154 induced 14.4 to 25.9-fold higher neutralizing antibodies against the Alpha, Beta, and Gamma variants. What’s more, it generates 17.8-fold neutralizing antibody titers against the Delta variant, which is considered the most infectious variant at the moment.

 

Expecting to Gain a EUA in December

ARCT-154 will undergo Phase 1/2/3 trials in Vietnam. Led by the Hanoi Medical University, it will recruit 100 people for Phase 1, 300 people for Phase 2, and 20,600 for Phase 3. Arcturus aims for a EUA from the Vietnam Ministry of Health (MoH) at the end of 2021 and expects to produce the first batch in early 2022.

To support the commercial production, the firm has teamed up with Vinbiocare Biotechnology Joint Stock Company (Vinbiocare) to build an mRNA vaccine production site in Vietnam in August.

As Arcturus revealed in its second-quarter financial report, ARCT-154 also commenced a Phase 1/2 trial in Singapore, testing the efficacy and safety as the primary shot and the booster shot for Pfizer’s COVID-19 vaccine.

 

Other COVID-19 Vaccine Trials in Vietnam

Besides ARCT-154, Vietnam has launched two other COVID-19 vaccine human trials. They are recombinant vaccine Nanocovax by Nanogen Pharmaceutical Biotechnology JSC and inactivated vaccine Covivac by Vietnam’s Institute of Vaccines and Medical Biologicals (IVAC). Currently, the former is in Phase 3 trial, and the latter is in Phase 2 trial and expected to enter Phase 3 in September.

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