Clinical trial NCT05043272: Safety and Immune Response of COVID-19 Vaccination in Overweight People With Excessive BMI
Official title: Safety and Immune Response of COVID-19 Vaccination in Overweight People With Excessive BMI
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Overweight
Keywords: COVID-19
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2021-09-14
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Overweight population with liver diseases or other basic diseases vaccinated with SARS-Cov-2 vaccine.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with adverse events after injection.
timeFrame: 1 month after vaccination
measure: Number of participants with adverse events after injection.
timeFrame: 3 months after vaccination
measure: Number of participants with adverse events after injection.
timeFrame: 6 months after vaccination
Secondary outcomes:
measure: Titer and duration of COVID-19 antibody production after vaccination
timeFrame: 1 month after vaccination
measure: Titer and duration of COVID-19 antibody production after vaccination
timeFrame: 3 months after vaccination
measure: Titer and duration of COVID-19 antibody production after vaccination
timeFrame: 6 months after vaccination
Other outcomes:
Locations:
city: Chongqing
country: China
facility: China
Study officials:
affiliation: The Second Affiliated Hospital of Chongqing Medical University
name: Hong Ren, PH D
role: PRINCIPAL_INVESTIGATOR
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