Confirmation of antibody production in early clinical trial of new coronavirus vaccine, peer-reviewed paper published by Chinese research team
Research laboratories and companies all over the world are doing their best to research and develop new coronavirus (SARS-CoV-2) vaccines, and some of them are already in the clinical trial stage. A Chinese research team published a peer-reviewed paper, stating, 'Antibody production was confirmed in a clinical trial of the SARS-CoV-2 vaccine under development.'
Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial
(PDF file)
Phase I Clinical Trial of a COVID-19 Vaccine in 18-60 Healthy Adults-Full Text View-ClinicalTrials.gov
https://clinicaltrials.gov/ct2/show/NCT04313127
Early study of Covid-19 vaccine developed in China sees mixed results
https://www.statnews.com/2020/05/22/early-study-of-covid-19-vaccine-developed-in-china-sees-mixed-results/
A vaccine developed by a collaborative research team of the Chinese Academy of Military Medical Sciences, Hubei Center for Disease Control and Prevention, Jiangsu Center for Disease Control and Prevention expresses a spiked glycoprotein on the surface of SARS-CoV-2. It is ' Ad5-nCoV ' in which the gene to be incorporated into adenovirus type 5.
Adenovirus, which is a DNA virus , is a completely different kind of virus from SARS-CoV-2, which is an RNA virus , but SARS-CoV- The spike protein of 2 is produced and immunity is acquired by using this as an antigen. In addition, since many people have immunity to adenovirus type 5 itself, 'I think that the immune system reacts not with SARS-CoV-2 but with adenovirus type 5 and the effectiveness of the vaccine may be lost.' Because of this concern, many research groups have forgotten the adoption of adenovirus type 5.
The Ad5-nCoV Phase I clinical trial started in mid-March 2020 and involved 108 healthy people aged 18 to under 60. About half of the subjects already had strong immunity to adenovirus type 5.
The research team divided the subjects into three groups and administered the vaccine to each group in three stages: high dose, medium dose, and low dose. Production of antibodies against spike proteins was confirmed 14 days after vaccination, and a significant increase in antibody levels could be confirmed in 105 out of 108 patients by 28 days after administration. In addition, T-cell responses to spike proteins were also observed, the team reports.
In addition, side effects such as inflammation at the injection site, fever, fatigue, and myalgia were observed, and 75% of subjects in the high-dose group had side effects. However, these side effects are within the range that can be predicted by vaccination using adenovirus type 5. In fact, people with high antibody levels against adenovirus type 5 tended to have fewer side effects. However, the research team also reported that the immune system's response to spike proteins was slightly diminished when there was strong immune memory for adenovirus type 5.
This paper is only an interim presentation, and clinical trials of Ad5-nCoV will continue, and the condition of the subjects administered this time will be continuously tracked until December 2020.
The SARS-CoV-2 vaccine ' mRNA-1273 ' developed by an American pharmaceutical company, Modelna, has started clinical trials almost at the same time as Ad5-nCoV. I got the result. ' mRNA-1273 is a vaccine that uses a different approach from Ad5-nCoV, in which mRNA that expresses spike proteins is directly administered to the body to target immunity.
Modelna's Corona Vaccine “Promising Results” in Initial Trial All 45 Patients Acquire Antibodies | World | Latest Articles | Newsweek Japan Official Site
https://www.newsweekjapan.jp/stories/world/2020/05/45-12.php
However, a medical science media Stat published an article suspicious about the effect of mRNA-1273 that 'the initial clinical trial of mRNA-1273 is small and has no significant meaning in evaluating efficacy'. It is reported that Moderna's stock price has fallen sharply as a result of this article.
Dow averages down $ 390, stalled by reports over Corona vaccine-Reuters
https://jp.reuters.com/article/ny-stx-us-idJPKBN22V347
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