Nat Med: Immunogenicity and safety of CoronaVac inactivated vaccine in patients with autoimmune rheumatism: Phase 4 clinical trial 

So far, the new crown virus has infected millions of people all over the world
.

Among them, Brazil is one of the countries with the largest number of confirmed cases and deaths of SARS-CoV-2.

Infect

The second wave of infection was driven by a variant of the gamma coronavirus, which is believed to be 2.
5 times more infectious than the original strain, and may be related to a higher risk of hospitalization and intensive care for patients under 60
.

The second peak in March and April 2021 resulted in more than twice the number of reported cases of COVID-19 infection than the first peak in 2020

COVID-19

CoronaVac, an inactivated virus vaccine against SARS-CoV-2, has been approved for emergency use by the World Health Organization (WHO) in many countries, including three of the six most populous countries in the world-Brazil, China and Turkey, this is very important for global control of this disease
.

The results of its Phase 3 clinical trials in China, Hong Kong, Indonesia, Brazil, Chile, the Philippines and Turkey are still being consolidated

At present, CoronaVac has accounted for about 75% of the vaccines injected in Brazil
.

It can be stored in cold storage, which is a huge advantage for deployment in developing countries

immunity

At present, the immunogenicity of CoronaVac in individuals with low immunity has not been well confirmed
.

To this end, the researchers initiated a prospective phase 4 controlled trial (No.

The main result of this clinical trial was that compared with the CG group, the ARD group had anti-SARS-CoV-2 IgG seroconversion (SC) and neutralizing antibodies (NAb) 6 weeks after the second dose (day 69 (D69)) The positive rate decreased by ≥15%
.

The secondary results are the IgG SC and NAb positive rate of D28, the IgG titers and neutralizing activity of D28 and D69, and the safety of the vaccine

Anti-SARS-CoV-2 S1/S2 IgG titers on D0, D28 and D69 in ARD patients and CG subjects

Anti-SARS-CoV-2 S1/S2 IgG titer of ARD patients and CG subjects at D0, D28 and D69 Anti-SARS-CoV-2 S1/S2 IgG of ARD patients and CG subjects at D0, D28 and D69 Titer

The results showed that the pre-specified endpoint has been reached.
The anti-SARS-Cov-2 IgG SC (70.
4% vs.
95.
5%, P<0.
001) and NAb positive rate (56.
3% vs.
79.
3%, P<0.
001) of the ARD group in D69 were both Below CG
.

In addition, the IgG titer (12.

The anti-SARS-Cov-2 IgG SC (70.

The IgG frequency (18.

Short-term immunogenicity is reduced but acceptable Short-term immunogenicity is reduced but acceptable

 

Original source:

Original source:

Ana C.
Medeiros-Ribeiro et al.
Immunogenicity and safety of the CoronaVac inactivated vaccine in patients with autoimmune rheumatic diseases: a phase 4 trial.
Nature Medicine (2 021).
 

Ana C.
Medeiros-Ribeiro et al.
Immunogenicity and safety of the CoronaVac inactivated vaccine in patients with autoimmune rheumatic diseases: a phase 4 trial.
Nature Medicine Immunogenicity and safety of the CoronaVac inactivated vaccine in patients with autoimmune rheumatic diseases: a phase 4 trial .
(2 021).
  

 

 

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