We are waiting for the results of Phase II
Chinese COVID-19 vaccine successfully tested on volunteers
Svetlana Maslova, Hi-tech+
The Ad5-nCoV vaccine caused a rapid immune response in all 108 volunteers, as well as good tolerability and safety for humans, the scientists said. The second phase of testing with the participation of 500 people has already been launched. In this group, the focus is on testing the vaccine on the elderly.
Scientists from The Beijing Institute of Biotechnology presented the results of the first phase of clinical trials of the Ad5-nCoV vaccine. They rated the results as promising: the vaccine showed safety and a rapid immune response against SARS-CoV-2 in all participants. A total of 108 men and women with an average age of 36 years took part in this stage. Their work is published in the Lancet journal (Zhu et al., Safety, tolerance, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomized, first-in-human trial).
The vaccine based on the adenovirus vector was administered intramuscularly – once in three different dosages in each group.
The level of neutralizing antibodies increased on day 14 after vaccination and peaked on day 28.
Scientists also recorded an increase in the number of binding antibodies in all participants, depending on the dosage of the vaccine. In particular, it stimulated a rapid T-cell response in most of the subjects, they stressed. The greatest response was in the groups with medium and high dosage.
The authors presented the results of side effects, which they assessed at the level of good tolerability. The most common reactions were injection site pain (in 54% of participants), fever (46%), fatigue (44%), headache (39%) and muscle pain (17%). One participant in the high-dose group had more serious reactions in the form of fatigue, shortness of breath and muscle pain, but they persisted only for two days.
The team has already launched the second phase of research involving 500 people.
At this stage, the vaccine will also be tested for participants over 60 years of age, who are considered the main risk group of COVID-19.
Scientists plan to evaluate only low and medium dosages. The main results and side effects will be measured within six months after vaccination.
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