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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 decline of immunity and cardiopulmonary function in patients with basic diseases (hypertension, diabetes, chronic obstructive pulmonary disease, chronic kidney disease, cancer diseases, etc.), COVID-19 's severe illness and mortality mainly increase in these special population. Vaccination of COVID-19 vaccine can effectively prevent COVID-19 virus infection and delay or prevent patients from developing into critical illness and reduce mortality.To evaluate the safety and effectiveness of the population vaccinated with COVID-19 vaccine, and to play a scientific and theoretical supporting role in guiding COVID-19 vaccination scientifically, reasonably and effectively, so this study was carried out.
Due to the decline of immunity and cardiopulmonary function in patients with basic diseases (hypertension, diabetes, chronic obstructive pulmonary disease, chronic kidney disease, cancer diseases, etc.), COVID-19 's severe illness and mortality mainly increase in these special population. At present, there is no evidence that these special population have been vaccinated against COVID-19, but CDC vaccination and the guidelines and consensus of various professional societies hold that: (1) the people with underlying diseases have low immunity and are easy to develop into severe patients with high mortality; (2) although there is no direct evidence of evidence-based medicine, it is best to be vaccinated with COVID-19 vaccine in the absence of disease progression activities to reduce high risk. To evaluate the safety and effectiveness of the population vaccinated with COVID-19 vaccine, and to play a scientific and theoretical supporting role in guiding COVID-19 vaccination scientifically, reasonably and effectively, so this study was carried out.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Basic diseases Patients/Healthy People | Hypertension, diabetes, chronic obstructive pulmonary disease, chronic kidney disease,Chronic Liver Diseases, Cancer diseases Patients |
|
| 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 15 days after vaccination | Evaluate the safety of the vaccine by observing the occurrence of adverse events(such as fever, dizziness, nausea, headache，fatigue, myalgia, etc) and recording the number of subjects with adverse events. | 15 days：Record the number of adverse reactions such as fever, dizziness, nausea, headache, fatigue, myalgia, etc. |
| Number of participants with adverse events 30 days after vaccination | Evaluate the safety of the vaccine by observing the occurrence of adverse events(such as fever, dizziness, nausea, headache，fatigue, myalgia, etc) and recording the number of subjects with adverse events. | 30 days:Record the number of adverse reactions such as fever, dizziness, nausea, headache, fatigue, myalgia, etc. |
| Number of participants with adverse events 60 days after vaccination | Evaluate the safety of the vaccine by observing the occurrence of adverse events(such as fever, dizziness, nausea, headache，fatigue, myalgia, etc) and recording the number of subjects with adverse events. | 60 days:Record the number of adverse reactions such as fever, dizziness, nausea, headache, fatigue, myalgia, etc. |
| Number of participants with adverse events 90 days after vaccination | Evaluate the safety of the vaccine by observing the occurrence of adverse events(such as fever, dizziness, nausea, headache，fatigue, myalgia, etc) and recording the number of subjects with adverse events. | 90 days:Record the number of adverse reactions such as fever, dizziness, nausea, headache, fatigue, myalgia, etc. |
| Number of participants with adverse events 180 days after vaccination | Evaluate the safety of the vaccine by observing the occurrence of adverse events(such as fever, dizziness, nausea, headache，fatigue, myalgia, etc) and recording the number of subjects with adverse events. |
| Measure | Description | Time Frame |
|---|---|---|
| Study on the immune mechanism related to the production of neutralizing antibodies 15 days after vaccination | After the entire vaccination process was completed, blood was drawn and samples were collected at four nodes 15 days, 30 days, 90 days, and 180 days for the levels of B cells and related subgroups、Treg and CTL. | 15 days:Detect the levels of B cells and related subgroups, Treg and CTL |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with basic diseases vaccinated with SARS-Cov-2 vaccine.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| DACHUAN M CAI, PH D | Contact | 18323409779 | 597521685@qq.com | |
| DAZHI M ZHANG, PH D | Contact | 13452382818 | dzhzhang@yahoo.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 |
|---|---|---|---|---|---|---|
| The second affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | Chongqing Municipality | 400010 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36849838 | Derived | Yang L, Xiang F, Wang D, Guo Q, Deng B, Jiang D, Ren H. The safety and immunogenicity of inactivated COVID-19 vaccine in old pulmonary tuberculosis patients. Eur J Clin Microbiol Infect Dis. 2023 Apr;42(4):503-512. doi: 10.1007/s10096-023-04566-0. Epub 2023 Feb 28. | |
| 36750902 | Derived | Xiang F, Long B, He J, Cheng F, Zhang S, Liu Q, Chen Z, Li H, Chen M, Peng M, Yin W, Liu D, Ren H. Impaired antibody responses were observed in patients with type 2 diabetes mellitus after receiving the inactivated COVID-19 vaccines. Virol J. 2023 Feb 7;20(1):22. doi: 10.1186/s12985-023-01983-7. |
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| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011024 | Pneumonia, Viral |
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| ID | Term |
|---|---|
| D000086663 | COVID-19 Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| 180 days:Record the number of adverse reactions such as fever, dizziness, nausea, headache, fatigue, myalgia, etc. |
| Titer and duration of COVID-19 antibody production 15 days after vaccination | The titer and duration of COVID-19 antibody were produced at 15 days, 30 days, 90 days, 180 days after vaccination, so as to clarify whether the level of immune response to COVID-19 vaccine was affected in people with basic disease. | 15 days:Detect the titer and duration of COVID-19 antibodies in the body. |
| Titer and duration of COVID-19 antibody production 30 days after vaccination | The titer and duration of COVID-19 antibody were produced at 15 days, 30 days, 90 days, 180 days after vaccination, so as to clarify whether the level of immune response to COVID-19 vaccine was affected in people with basic disease. | 30 days:Detect the titer and duration of COVID-19 antibodies in the body. |
| Titer and duration of COVID-19 antibody production 60 days after vaccination | The titer and duration of COVID-19 antibody were produced at 15 days, 30 days, 90 days, 180 days after vaccination, so as to clarify whether the level of immune response to COVID-19 vaccine was affected in people with basic disease. | 60 days:Detect the titer and duration of COVID-19 antibodies in the body. |
| Titer and duration of COVID-19 antibody production 90 days after vaccination | The titer and duration of COVID-19 antibody were produced at 15 days, 30 days, 90 days, 180 days after vaccination, so as to clarify whether the level of immune response to COVID-19 vaccine was affected in people with basic disease. | 90 days:Detect the titer and duration of COVID-19 antibodies in the body. |
| Titer and duration of COVID-19 antibody production180 days after vaccination | The titer and duration of COVID-19 antibody were produced at 15 days, 30 days, 90 days, 180 days after vaccination, so as to clarify whether the level of immune response to COVID-19 vaccine was affected in people with basic disease. | 180 days:Detect the titer and duration of COVID-19 antibodies in the body. |
| Study on the immune mechanism related to the production of neutralizing antibodies 30 days after vaccination | After the entire vaccination process was completed, blood was drawn and samples were collected at four nodes 15 days, 30 days, 90 days, and 180 days for the levels of B cells and related subgroups、Treg and CTL. | 30 days：Detect the levels of B cells and related subgroups, Treg and CTL |
| Study on the immune mechanism related to the production of neutralizing antibodies 60 days after vaccination | After the entire vaccination process was completed, blood was drawn and samples were collected at four nodes 15 days, 30 days, 90 days, and 180 days for the levels of B cells and related subgroups、Treg and CTL. | 60 days：Detect the levels of B cells and related subgroups, Treg and CTL |
| Study on the immune mechanism related to the production of neutralizing antibodies 90 days after vaccination | After the entire vaccination process was completed, blood was drawn and samples were collected at four nodes 15 days, 30 days, 90 days, and 180 days for the levels of B cells and related subgroups、Treg and CTL. | 90 days：Detect the levels of B cells and related subgroups, Treg and CTL |
| Study on the immune mechanism related to the production of neutralizing antibodies 180 days after vaccination | After the entire vaccination process was completed, blood was drawn and samples were collected at four nodes 15 days, 30 days, 90 days, and 180 days for the levels of B cells and related subgroups、Treg and CTL. | 180 days：Detect the levels of B cells and related subgroups, Treg and CTL |
| 36620297 | Derived | Guo Q, Yang L, Peng R, Gao T, Chu X, Jiang D, Ke D, Ren H. Safety and immunogenicity of inactivated COVID-19 vaccine in patients with metabolic syndrome: A cross-sectional observational study. Front Public Health. 2022 Dec 23;10:1067342. doi: 10.3389/fpubh.2022.1067342. eCollection 2022. |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |