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On 11 February 2020, the International Committee for the Classification of Viruses named the disease caused by SAï¼²S-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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Overweight population with basic diseases | Basic diseases include diabetes, hypertension. |
| |
| Overweight population with chronic liver diseases | Chronic liver diseases include chronic hepatitis ,liver cirrhosis, primary hepatocellular carcinoma. |
| |
| Healthy population | Control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SARS-COV-2 VACCINE | Biological | The antibody titer and adverse reactions were observed. |
|
| 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 |
| 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 |
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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:
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Overweight population with liver diseases or other basic diseases vaccinated with SARS-Cov-2 vaccine.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| CHUAN DA CAI, PH D | Contact | 18323409779 | 597521685@qq.com | |
| JUAN KANG, PH D | Contact | 13996112052 | 68368892@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Hong Ren, PH D | The Second Affiliated Hospital of Chongqing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China | Recruiting | Chongqing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31986264 | Background | Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. | |
| 31978945 |
| Label | URL |
|---|---|
| World Health Organization (WHO) Influenza (Seasonal) 2018 Available from | View source |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Not provided
| ID | Term |
|---|---|
| D000086663 | COVID-19 Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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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 |
| Background |
| Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24. |
| 32145190 | Background | Zhang C, Shi L, Wang FS. Liver injury in COVID-19: management and challenges. Lancet Gastroenterol Hepatol. 2020 May;5(5):428-430. doi: 10.1016/S2468-1253(20)30057-1. Epub 2020 Mar 4. No abstract available. |
| 31441906 | Background | Grohskopf LA, Alyanak E, Broder KR, Walter EB, Fry AM, Jernigan DB. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices - United States, 2019-20 Influenza Season. MMWR Recomm Rep. 2019 Aug 23;68(3):1-21. doi: 10.15585/mmwr.rr6803a1. |
| 32109013 | Background | Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28. |
| 32504052 | Result | Xu X, Sun J, Nie S, Li H, Kong Y, Liang M, Hou J, Huang X, Li D, Ma T, Peng J, Gao S, Shao Y, Zhu H, Lau JY, Wang G, Xie C, Jiang L, Huang A, Yang Z, Zhang K, Hou FF. Seroprevalence of immunoglobulin M and G antibodies against SARS-CoV-2 in China. Nat Med. 2020 Aug;26(8):1193-1195. doi: 10.1038/s41591-020-0949-6. Epub 2020 Jun 5. |
| 33257893 | Result | Shi Q, Hu Y, Peng B, Tang XJ, Wang W, Su K, Luo C, Wu B, Zhang F, Zhang Y, Anderson B, Zhong XN, Qiu JF, Yang CY, Huang AL. Effective control of SARS-CoV-2 transmission in Wanzhou, China. Nat Med. 2021 Jan;27(1):86-93. doi: 10.1038/s41591-020-01178-5. Epub 2020 Nov 30. |
| 32555424 | Result | Long QX, Tang XJ, Shi QL, Li Q, Deng HJ, Yuan J, Hu JL, Xu W, Zhang Y, Lv FJ, Su K, Zhang F, Gong J, Wu B, Liu XM, Li JJ, Qiu JF, Chen J, Huang AL. Clinical and immunological assessment of asymptomatic SARS-CoV-2 infections. Nat Med. 2020 Aug;26(8):1200-1204. doi: 10.1038/s41591-020-0965-6. Epub 2020 Jun 18. |
| 32350462 | Result | Long QX, Liu BZ, Deng HJ, Wu GC, Deng K, Chen YK, Liao P, Qiu JF, Lin Y, Cai XF, Wang DQ, Hu Y, Ren JH, Tang N, Xu YY, Yu LH, Mo Z, Gong F, Zhang XL, Tian WG, Hu L, Zhang XX, Xiang JL, Du HX, Liu HW, Lang CH, Luo XH, Wu SB, Cui XP, Zhou Z, Zhu MM, Wang J, Xue CJ, Li XF, Wang L, Li ZJ, Wang K, Niu CC, Yang QJ, Tang XJ, Zhang Y, Liu XM, Li JJ, Zhang DC, Zhang F, Liu P, Yuan J, Li Q, Hu JL, Chen J, Huang AL. Antibody responses to SARS-CoV-2 in patients with COVID-19. Nat Med. 2020 Jun;26(6):845-848. doi: 10.1038/s41591-020-0897-1. Epub 2020 Apr 29. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |