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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Covid19, Diseases, Chronic, Adverse Reaction to Vaccine

Intervention / Treatment
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* Biological: SARS-COV-2 VACCINE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The selection criteria should follow the disease diagnosis guidelines developed by various colleges and the consensus of expert recommendations on vaccination. Exclusion Criteria: The exclusion criteria should follow the disease diagnosis guidelines developed by various colleges and the consensus of expert recommendations on vaccination.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Basic diseases Patients/Healthy People<br>Hypertension, diabetes, chronic obstructive pulmonary disease, chronic kidney disease,Chronic Liver Diseases, Cancer diseases Patients | Biological: SARS-COV-2 VACCINE<br>* the antibody titer and adverse reactions were observed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events 15 days after vaccination | 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. | 15 days：Record the number of adverse reactions such as fever, dizziness, nausea, headache, fatigue, myalgia, etc. | 
| Number of participants with adverse events 30 days after vaccination | 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. | 30 days:Record the number of adverse reactions such as fever, dizziness, nausea, headache, fatigue, myalgia, etc. | 
| Number of participants with adverse events 60 days after vaccination | 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. | 60 days:Record the number of adverse reactions such as fever, dizziness, nausea, headache, fatigue, myalgia, etc. | 
| Number of participants with adverse events 90 days after vaccination | 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. | 90 days:Record the number of adverse reactions such as fever, dizziness, nausea, headache, fatigue, myalgia, etc. | 
| Number of participants with adverse events 180 days after vaccination | 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. | 180 days:Record the number of adverse reactions such as fever, dizziness, nausea, headache, fatigue, myalgia, etc. | 
| Titer and duration of COVID-19 antibody production 15 days after vaccination | 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. | 15 days:Detect the titer and duration of COVID-19 antibodies in the body. | 
| Titer and duration of COVID-19 antibody production 30 days after vaccination | 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. | 30 days:Detect the titer and duration of COVID-19 antibodies in the body. | 
| Titer and duration of COVID-19 antibody production 60 days after vaccination | 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. | 60 days:Detect the titer and duration of COVID-19 antibodies in the body. | 
| Titer and duration of COVID-19 antibody production 90 days after vaccination | 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. | 90 days:Detect the titer and duration of COVID-19 antibodies in the body. | 
| Titer and duration of COVID-19 antibody production180 days after vaccination | 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. | 180 days:Detect the titer and duration of COVID-19 antibodies in the body. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study on the immune mechanism related to the production of neutralizing antibodies 15 days after vaccination | 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. | 15 days:Detect the levels of B cells and related subgroups, Treg and CTL | 
| Study on the immune mechanism related to the production of neutralizing antibodies 30 days after vaccination | 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. | 30 days：Detect the levels of B cells and related subgroups, Treg and CTL | 
| Study on the immune mechanism related to the production of neutralizing antibodies 60 days after vaccination | 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. | 60 days：Detect the levels of B cells and related subgroups, Treg and CTL | 
| Study on the immune mechanism related to the production of neutralizing antibodies 90 days after vaccination | 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. | 90 days：Detect the levels of B cells and related subgroups, Treg and CTL | 
| Study on the immune mechanism related to the production of neutralizing antibodies 180 days after vaccination | 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. | 180 days：Detect the levels of B cells and related subgroups, Treg and CTL | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, vaccine, basic diseases, cancer diseases