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

C

Chongqing Medical University

Status

Unknown

Conditions

Overweight
Covid19

Treatments

Biological: SARS-COV-2 VACCINE

Study type

Observational

Funder types

Other

Identifiers

NCT05043272
2021-76

Details and patient eligibility

About

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.

Full description

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.

Enrollment

450 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.
  1. 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

Trial design

450 participants in 3 patient groups

Overweight population with basic diseases
Description:
Basic diseases include diabetes, hypertension.
Treatment:
Biological: SARS-COV-2 VACCINE
Overweight population with chronic liver diseases
Description:
Chronic liver diseases include chronic hepatitis ,liver cirrhosis, primary hepatocellular carcinoma.
Treatment:
Biological: SARS-COV-2 VACCINE
Healthy population
Description:
Control group
Treatment:
Biological: SARS-COV-2 VACCINE

Trial contacts and locations

1

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Central trial contact

CHUAN DA CAI, PH D; JUAN KANG, PH D

Data sourced from clinicaltrials.gov

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