Lancet Infect Dis: Candidate Covid-19 inactivated vaccine Coronac has a good effect

CoronaVac is a candidate Covid-19 inactivated vaccine containing inactivated Severe Acute Respiratory Syndrome Coronavirus 2 (sars-cov-2).
recently looked at the safety, tolerance and immunogenicity of the CoronaVac vaccine.
study was conducted in a randomized, double-blind, placebo-controlled Phase 1/2 clinical trial in Suining County, Jiangsu Province, China, to recruit healthy adults aged 18-59.
trial vaccine used in Phase 1 trials was made using a cell factory process, while the experimental vaccine used in Phase 2 was produced through a bioreacter process.
phase I trial is a dose increment test.
At the time of the screening, participants were divided into two vaccination plan queues, day 0 and day 14, and day 0 and 28, respectively, in which participants received a low dose of TheonaVac vaccine (3 sg) containing aluminium hydroxide ad adhesive, a high dose of the vaccine (6 sg) or the same dose of placebo.
In the Phase 2 trial, participants were divided into vaccination queues on days 0 and 14, vaccination queues on days 0 and 28, and received low-dose, high-dose CoronaVac or placebo.
safety endpoint of the study was adverse reactions of all participants within 28 days of injection.
primary immunogenicity is the neutralized antibody serum conversion rate of SARS-CoV-2 after 14 or 28 days after vaccination.
144 participants participated in the first phase of the trial, and a total of 600 participants participated in the second phase of the trial.
in phase 1 trials, the risk of adverse reactions in the 3 sg group was 29%, in the 6 sg group 38%, and in the placebo group 8%.
in the 0th and 28th days of the queue, the rate of adverse events was 13 percent in the 3 sg group, 17 percent in the 6 sg group, and 13 percent in the placebo group.
On the 14th day after the 0th and 14th days of the vaccination program, the serum conversion rate was 46% in the 3μg group and 50% in the 6?g group, while the serum conversion of the antibody was non-participants in the placebo group, and on the 28th day after the 0th and 28th day of the vaccination program, the serum conversion rate in the 3μg group was 83%, and in the 6μg group 79%, and in the placebo group 4%.
In the Phase 2 trial, the rate of adverse reactions in the 0th and 14th days of the queue was 33 per cent in the 3 sg group, 35 per cent in the 6 sg group and 22 per cent in the placebo group;
on the 14th day after vaccination in the 0th and 14th days group, 92% of the participants in the 3μg group showed serotonin transformation of the antibody, 98% in the 6μg group, and 3% of the participants in the placebo group showed blood in the antibody On the 28th day after the 0th and 28th days of the vaccination program, 97% of the participants in the 3 sg group had serum conversion, 100% of the participants in the 6 sg group had serum transformation, and no serum transformation was seen in the placebo group.
clinical studies have confirmed that the candidate Covid-19 inactivated vaccine Coronac has better safety and immunogenicity, and will be used in future 3 μg doses for subsequent Phase 3 clinical studies.