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the antibody titer and adverse reactions were observed.

SARS-COV-2 VACCINE

DACHUAN M CAI, PH D

DAZHI M ZHANG, PH D

Hong Ren, PH D

On 11 February 2020, the International Committee for the Classification of Viruses named the disease caused by SAＲS-CoV-2 infection in humans as the new coronavirus pneumonia (coronavirus disease 2019, COVID-19).Due to the decline of immunity and cardiopulmonary function in patients with basic diseases (hypertension, diabetes, chronic obstructive pulmonary disease, chronic kidney disease, cancer diseases, etc.), COVID-19 's severe illness and mortality mainly increase in these special population. Vaccination of COVID-19 vaccine can effectively prevent COVID-19 virus infection and delay or prevent patients from developing into critical illness and reduce mortality.To evaluate the safety and effectiveness of the population vaccinated with COVID-19 vaccine, and to play a scientific and theoretical supporting role in guiding COVID-19 vaccination scientifically, reasonably and effectively, so this study was carried out.

Due to the decline of immunity and cardiopulmonary function in patients with basic diseases (hypertension, diabetes, chronic obstructive pulmonary disease, chronic kidney disease, cancer diseases, etc.), COVID-19 's severe illness and mortality mainly increase in these special population. At present, there is no evidence that these special population have been vaccinated against COVID-19, but CDC vaccination and the guidelines and consensus of various professional societies hold that: (1) the people with underlying diseases have low immunity and are easy to develop into severe patients with high mortality; (2) although there is no direct evidence of evidence-based medicine, it is best to be vaccinated with COVID-19 vaccine in the absence of disease progression activities to reduce high risk. To evaluate the safety and effectiveness of the population vaccinated with COVID-19 vaccine, and to play a scientific and theoretical supporting role in guiding COVID-19 vaccination scientifically, reasonably and effectively, so this study was carried out.

Safety and Immune Response of COVID-19 Vaccination in Patients With Basic Disease

Evaluate the safety of the vaccine by observing the occurrence of adverse events(such as fever, dizziness, nausea, headache，fatigue, myalgia, etc) and recording the number of subjects with adverse events.

The titer and duration of COVID-19 antibody were produced at 15 days, 30 days, 90 days, 180 days after vaccination, so as to clarify whether the level of immune response to COVID-19 vaccine was affected in people with basic disease.

After the entire vaccination process was completed, blood was drawn and samples were collected at four nodes 15 days, 30 days, 90 days, and 180 days for the levels of B cells and related subgroups、Treg and CTL.

The Second Affiliated Hospital of Chongqing Medical University

Dr/ Prof.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Safety and Immune Response of COVID-19 Vaccination in Patients With Basic Disease	NCT05043246	Diseases, Chron... Covid19 Adverse Reactio...	SARS-COV-2 VACC...	18 Years - 80 Years	The Second Affiliated Hospital of Chongqing Medical University
Safety and Immune Response of COVID-19 Vaccination in Patients With Basic Disease	NCT05043246	Diseases, Chron... Covid19 Adverse Reactio...	SARS-COV-2 VACC...	18 Years - 80 Years	The Second Affiliated Hospital of Chongqing Medical University

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