Safety and Immune Response of COVID-19 Vaccination in Patients With Basic Disease

Covid19 Clinical Trial

— SIM-PBD  

Official title:

Safety and Immune Response of COVID-19 Vaccination in Patients With Basic Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05043246
• Other study ID #: 2021-49
• Status: Recruiting
• Start date: August 1, 2021
• Est. completion date: August 1, 2023

Study information

• Verified date: August 2022
• Source: The Second Affiliated Hospital of Chongqing Medical University
• Contact: DACHUAN M CAI, PH D
• Phone: 18323409779
• Email: 597521685[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2300
• Est. completion date: August 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 exclusion criteria should follow the disease diagnosis guidelines developed by various colleges and the consensus of expert recommendations on vaccination.

Related Conditions & MeSH terms

• Adverse Reaction to Vaccine
• COVID-19
• Covid19

Intervention

Biological:
• SARS-COV-2 VACCINE
the antibody titer and adverse reactions were observed.

Locations

Country	Name	City	State
China	The second affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.	180 days:Record the number of adverse reactions such as fever, dizziness, nausea, headache, fatigue, myalgia, etc.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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