The results of the phase I clinical trial of the first domestic mRNA covid-19 vaccine were announced

China's first mRNA COVID-19 vaccine, ARCoV, announced the results of a Phase I clinical trial.

On January 24, the results of a double-blind, randomized, placebo-controlled Phase I clinical trial of ARCoV, developed by Watson Biologics, Abbott Biologics, and the Academy of Military Medical Sciences, were published in The Lancet.

Source: Lancet

There were 120 participants in 6 groups (5 dose levels + placebo groups) with dose levels of 5 micrograms, 10 micrograms, 15 micrograms, 20 micrograms, and 25 micrograms.

The results showed that subjects receiving two doses of 15 μg produced the highest titer of neutralizing antibodies, about twice as many as in patients who recovered from COVID-19. But increasing the dose thereafter did not increase the antibody titer, which is similar to Pfizer's mRNA vaccine.

No serious adverse events occurred during the trial, with the most common grade 3 adverse reaction being fever, with a similar incidence to Pfizer's mRNA vaccine. Grade 3 adverse reactions are severe or clinically apparent reactions that are not immediately fatal and require hospital intervention or prolonged hospital stay.

The study had three limitations: the first was that the sample size was small, the second was that the subjects were limited to Chinese adults aged 18 to 59 years, and the third was that the safety and efficacy of the vaccine remained to be evaluated.

Currently, Phase III clinical trials are underway.

Curated: Ground cat

Executive Producer: Gyouza

Source: The Lancet