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The new coronary pneumonia vaccine is currently the most clinically urgent medical resource, and researchers from China recently evaluated the safety and immunogenicity of the inactivated all-virus Covid-19 vaccine.
The study was a Phase I-II clinical study in which 96 participants were recruited to receive three doses of the vaccine (2.5, 5 and 10 sg/times) or a placebo group of 24 people in each group, with subjects receiving three intramuscular injections on days 0, 28 and 56.
Phase II study phase, 224 adult volunteers received 5 sg/secondary vaccine in two groups, one on the 0th and 14th days (n=84) or a placebo (n=28), and the 2nd group received the vaccine (n=84) or a placebo (n=28) on the 0th and 21st days.
safety endpoint of the study was adverse events 7 days after injection, and the end point of efficacy was the mid-antibody response within 14 days of vaccination.
age of participants was 42.8 years, with 62.5 per cent female.
Phase I study phase, in the placebo group, the low-dose vaccine group, the medium-dose vaccine group and the high-dose vaccine group, adverse events occurred in 3 cases (12.5%), 5 cases (20.8%), 4 cases (16.7%) and 6 cases (25.0%) within 7 days. in the
II study phase, four people in the placebo group (14.3%) and five people in the vaccine group (6.0%) had adverse events after receiving the vaccine, and five people in the placebo group (17.9%) and 16 people in the vaccine group (19.0%) had adverse events after receiving the vaccine.
most common adverse events include pain at the injection site, followed by fever, mostly mild and self-limiting adverse events, with no serious adverse reactions. In the phase
I study, the geometric average titration of the meso-antibody was 316, 206 and 297 in the low-to-high-dose group after 3 doses of vaccination, and in the Phase II study, the geometric average titration of the meso-antibody after the first group was inoculated was 121, the second group was 247, and the placebo group did not detect the meso-antibody.
I-II study, the inactivated all-virus Covid-19 vaccine is safe and induces healthy volunteers to produce immune antibodies.
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