The picture shows the Watson biological mRNA test vaccine
The highly anticipated clinical results of phase I of the first domestic new crown mRNA vaccine (ARCoV) were announced and published in the journal Lancet Microbiology on January 24.
For more information, please see thesis link: https://doi.org/10.1016/S2666-5247(21)00280-9
The COVID-19 mRNA vaccine was developed by Watson Biologics, Abbott Biologics and the Academy of Military Medical Sciences. Phase I clinical trials of the ARCoV vaccine to assess the vaccine's initial safety, tolerability, and immunogenicity.
The main results of the clinical trial and related main information are as follows:
1. The Phase I clinical trial of the ARCoV vaccine was conducted in Shulan Hospital in Hangzhou, Zhejiang Province, and the trial was single-centered, double-blind, randomized, placebo-controlled, and dose-increasing.
2. During the period from October 30 to December 2, 2020, a total of 230 people were recruited, and then 120 eligible subjects were randomly selected from healthy adults aged 18-59 years old with negative covid-19 infection;
3. Subjects were randomly divided into 6 groups, 5 dose-level test groups and placebo (20 people per group), and the dose levels were 5 μg, 10 μg, 15 μg, 20 μg and 25 μg in turn.
4. All subjects received the first vaccination, and 118 people received the second dose. Within 56 days of vaccination, no serious adverse events were reported and most adverse events were mild or moderate.
5. Fever is the most common adverse reaction in the trial: 1 case in the 5 μg group (proportion of 5%), 13 cases in the 10 μg group (proportion of 65%), 17 cases in the 15 μg group (proportion of 5%), 19 cases in the 20 μg group (proportion of 95%), 16 cases in the 25 μg group (proportion of 100%);
The incidence of systemic adverse events of grade 6.3 was 0% in the 5 μg group, 15% in the 10 μg group, 30% in the 15 μg group, 35% in the 20 μg group, 31% in the 25 μg group, and 0% in the placebo group. (Note: The so-called grade 3 adverse reactions, which are serious or clinically obvious, but not immediately fatal, require hospital intervention or prolonged hospital stay)
7. The fever subsided within 2 days after vaccination in all trial groups, and the incidence of adverse events caused by the first and second vaccinations of the ARCoV vaccine was similar.
8. Humoral immunity including anti-RBD IgG and neutralizing antibodies increased significantly 7 days after the second dose, after which it peaked at 14 to 28 days. The specific T-cell response peaks between 7 and 14 days after full vaccination (two doses).
The 9.15 μg test group induced the highest titer of neutralizing antibodies, about twice as many as those in patients who recovered from COVID-19.
10. Finally, the Lancet paper points out that the ARCoV vaccine is safe, well tolerated in 5 dose groups, and can induce a strong humoral and cellular immune response.
Founded in January 2019, Aibo Biotech is a clinical-stage innovative biomedical company focusing on the research and development of messenger ribonucleic acid (mRNA) drugs.
Soon after the outbreak of the new crown epidemic, Aibo Bio launched the research and development of a new crown vaccine. As early as September 2020, InBev, CEO of Aibo Biotech, said at a conference that they had obtained a Phase I clinical trial, but the results were undecided.
On April 19, 2021, the Phase II clinical trial of the new crown mRNA vaccine jointly developed by Watson Biology, Abbott Biology and the Military Medical Research Institute of the Academy of Military Sciences is nearing completion. At the same time, they have begun overseas trials of phase III clinical trials of the new crown mRNA vaccine.
In September 2021, Watson Biotech announced to the outside world that its phase III clinical trial of the new coronavirus mRNA vaccine ARCoVaX (ARCoV) developed in cooperation with Aibo Biologics was approved by the Drug Regulatory Authorities of Mexico and Indonesia respectively.
Hopefully, we will not be too far away from the domestic COVID-19 mRNA vaccine.
The following are the key data of this clinical trial:
Introduction of subjects
Adverse reaction profile data
Antibodies and neutralization reactions in the ARCoV Phase I trial
T cell immune responses induced in the ARCoV Phase I trial