Adverse Reaction to Vaccine, Covid19, Diseases, Chronic
Conditions
Keywords
COVID-19, vaccine, basic diseases, cancer diseases
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 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.
Detailed description
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.
Interventions
BIOLOGICALSARS-COV-2 VACCINE
the antibody titer and adverse reactions were observed.
Sponsors
The Second Affiliated Hospital of Chongqing Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* The selection criteria should follow the disease diagnosis guidelines developed by various colleges and the consensus of expert recommendations on vaccination.
Exclusion criteria
* The
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Titer and duration of COVID-19 antibody production180 days after vaccination | 180 days:Detect the titer and duration of COVID-19 antibodies in the body. | 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. |
| Number of participants with adverse events 180 days after vaccination | 180 days:Record the number of adverse reactions such as fever, dizziness, nausea, headache, fatigue, myalgia, etc. | 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. |
| Titer and duration of COVID-19 antibody production 15 days after vaccination | 15 days:Detect the titer and duration of COVID-19 antibodies in the body. | 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. |
| Titer and duration of COVID-19 antibody production 30 days after vaccination | 30 days:Detect the titer and duration of COVID-19 antibodies in the body. | 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. |
| Titer and duration of COVID-19 antibody production 60 days after vaccination | 60 days:Detect the titer and duration of COVID-19 antibodies in the body. | 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. |
| Titer and duration of COVID-19 antibody production 90 days after vaccination | 90 days:Detect the titer and duration of COVID-19 antibodies in the body. | 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. |
| Number of participants with adverse events 15 days after vaccination | 15 days：Record the number of adverse reactions such as fever, dizziness, nausea, headache, fatigue, myalgia, etc. | 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. |
| Number of participants with adverse events 30 days after vaccination | 30 days:Record the number of adverse reactions such as fever, dizziness, nausea, headache, fatigue, myalgia, etc. | 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. |
| Number of participants with adverse events 60 days after vaccination | 60 days:Record the number of adverse reactions such as fever, dizziness, nausea, headache, fatigue, myalgia, etc. | 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. |
| Number of participants with adverse events 90 days after vaccination | 90 days:Record the number of adverse reactions such as fever, dizziness, nausea, headache, fatigue, myalgia, etc. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Study on the immune mechanism related to the production of neutralizing antibodies 30 days after vaccination | 30 days：Detect the levels of B cells and related subgroups, Treg and CTL | 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. |
| Study on the immune mechanism related to the production of neutralizing antibodies 60 days after vaccination | 60 days：Detect the levels of B cells and related subgroups, Treg and CTL | 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. |
| Study on the immune mechanism related to the production of neutralizing antibodies 90 days after vaccination | 90 days：Detect the levels of B cells and related subgroups, Treg and CTL | 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. |
| Study on the immune mechanism related to the production of neutralizing antibodies 180 days after vaccination | 180 days：Detect the levels of B cells and related subgroups, Treg and CTL | 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. |
| Study on the immune mechanism related to the production of neutralizing antibodies 15 days after vaccination | 15 days:Detect the levels of B cells and related subgroups, Treg and CTL | 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. |
Countries
China
Contacts
Primary ContactDACHUAN M CAI, PH D
Backup ContactDAZHI M ZHANG, PH D
Outcome results
None listed