Safety and Immune Response of COVID-19 Vaccination in Overweight People With Excessive BMI

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 changes of immune function and cardiopulmonary function in overweight people, the infection and severity of these patients are higher than that of the general population during the epidemic period. More attention should be paid to personal protection and disease prevention. Vaccination with COVID-19 vaccine can effectively prevent COVID-19 infection, delay or prevent patients from developing into critical illness and reducing mortality. In order to evaluate the safety and efficacy of COVID-19 vaccine for overweight people, and to guide COVID-19 vaccination more scientifically, rationally and effectively, this study was carried out.

Detailed Description
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Due to the changes of immune function and cardiopulmonary function in overweight people, the infection and severity of these patients are higher than that of the general population during the epidemic period. More attention should be paid to personal protection and disease prevention. Vaccination of COVID-19 can effectively prevent COVID-19 virus infection and delay or prevent patients from developing into critical illness and reduce mortality. The safety and effectiveness of COVID-19 vaccine in this population were evaluated in order to play a scientific and theoretical supporting role in guiding COVID-19 vaccination more scientifically, reasonably and effectively. The samples of this study were collected and tested in the second affiliated Hospital of Chongqing Medical University. Patients with contraindications for vaccination will be excluded. The detected indexes included blood routine test, liver function, COVID-19 antibody titer, antibody duration and other indexes of healthy people (control group) and overweight people after vaccination ( 1, 3, 6 months after vaccination). The adverse reactions related to the vaccine were recorded.

Official Title
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Safety and Immune Response of COVID-19 Vaccination in Overweight People With Excessive BMI

Conditions
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Covid19, Overweight

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: - 1.Healthy group were as follows: no history of hepatitis, no history of liver cirrhosis, no history of liver cancer and receiving the whole-course COVID-19 vaccination. 2. Overweight people are defined as having a BMI of more than 24 and receiving the whole-course COVID-19 vaccination. Exclusion Criteria: Patients previously diagnosed or with a history of contact with confirmed cases

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Overweight population with basic diseases<br>Basic diseases include diabetes, hypertension. | Biological: SARS-COV-2 VACCINE<br>* The antibody titer and adverse reactions were observed.<br>|
| Overweight population with chronic liver diseases<br>Chronic liver diseases include chronic hepatitis ,liver cirrhosis, primary hepatocellular carcinoma. | Biological: SARS-COV-2 VACCINE<br>* The antibody titer and adverse reactions were observed.<br>|
| Healthy population<br>Control group | 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 after injection. | The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated. | 1 month after vaccination | 
| Number of participants with adverse events after injection. | The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated. | 3 months after vaccination | 
| Number of participants with adverse events after injection. | The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated. | 6 months after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Titer and duration of COVID-19 antibody production after vaccination | The titer and duration of COVID-19 antibody were produced at 1 month | 1 month after vaccination | 
| Titer and duration of COVID-19 antibody production after vaccination | The titer and duration of COVID-19 antibody were produced at 3 months | 3 months after vaccination | 
| Titer and duration of COVID-19 antibody production after vaccination | The titer and duration of COVID-19 antibody were produced at 6 months | 6 months after vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19