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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05043272
Enrollment
450
Registered
2021-09-14
Start date
2021-08-01
Completion date
2022-08-01
Last updated
2021-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, Overweight

Keywords

COVID-19

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.

Interventions

The antibody titer and adverse reactions were observed.

Sponsors

The Second Affiliated Hospital of Chongqing Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with adverse events after injection.1 month after vaccinationThe vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated.

Secondary

MeasureTime frameDescription
Titer and duration of COVID-19 antibody production after vaccination1 month after vaccinationThe titer and duration of COVID-19 antibody were produced at 1 month

Countries

China

Contacts

Primary ContactCHUAN DA CAI, PH D
597521685@qq.com18323409779
Backup ContactJUAN KANG, PH D
68368892@qq.com13996112052

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026