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Safety and Immune Response of COVID-19 Vaccination in Middle-aged and Elderly Patients With Basic Disease (SIM-MIEPBD)

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ClinicalTrials.gov Identifier: NCT05043246
Recruitment Status : Recruiting
First Posted : September 14, 2021
Last Update Posted : September 17, 2021
Sponsor:
Information provided by (Responsible Party):
Hong Ren, The Second Affiliated Hospital of Chongqing Medical University

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 the middle-aged and elderly, COVID-19 's severe illness and mortality mainly occur in the middle-aged and elderly over the age of 60, especially those with basic diseases (hypertension, diabetes, chronic obstructive pulmonary disease, chronic kidney disease, etc.). 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.

Condition or disease Intervention/treatment
Diseases, Chronic Covid19 Adverse Reaction to Vaccine Biological: SARS-COV-2 VACCINE

Detailed Description:
Due to the decline of immunity and cardiopulmonary function in the middle-aged and elderly, COVID-19 's severe illness and mortality mainly occur in the middle-aged and elderly over the age of 60, especially those with basic diseases (hypertension, diabetes, chronic obstructive pulmonary disease, chronic kidney disease, etc.). At present, there is no evidence that the middle-aged and elderly people with these types of diseases have been vaccinated against COVID-19, but CDC vaccination and the guidelines and consensus of various professional societies hold that: (1) the middle-aged and elderly are susceptible; (2) the people with underlying diseases have low immunity and are easy to develop into severe patients with high mortality; (3) 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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Study Type : Observational
Estimated Enrollment : 2300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Safety and Immune Response of COVID-19 Vaccination in Middle-aged and Elderly Patients With Basic Disease
Actual Study Start Date : August 1, 2021
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : August 1, 2022

Group/Cohort Intervention/treatment
Basic diseases Patients/Healthy People
Hypertension, diabetes, chronic obstructive pulmonary disease, chronic kidney disease,Chronic Liver Diseases Patients
Biological: SARS-COV-2 VACCINE
the antibody titer and adverse reactions were observed.




Primary Outcome Measures :
  1. Number of participants with adverse events 15 days after vaccination [ Time Frame: 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.

  2. Number of participants with adverse events 30 days after vaccination [ Time Frame: 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.

  3. Number of participants with adverse events 60 days after vaccination [ Time Frame: 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.

  4. Number of participants with adverse events 90 days after vaccination [ Time Frame: 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.

  5. Number of participants with adverse events 180 days after vaccination [ Time Frame: 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.

  6. Titer and duration of COVID-19 antibody production 15 days after vaccination [ Time Frame: 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.

  7. Titer and duration of COVID-19 antibody production 30 days after vaccination [ Time Frame: 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.

  8. Titer and duration of COVID-19 antibody production 60 days after vaccination [ Time Frame: 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.

  9. Titer and duration of COVID-19 antibody production 90 days after vaccination [ Time Frame: 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.

  10. Titer and duration of COVID-19 antibody production180 days after vaccination [ Time Frame: 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.


Secondary Outcome Measures :
  1. Study on the immune mechanism related to the production of neutralizing antibodies 15 days after vaccination [ Time Frame: 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.

  2. Study on the immune mechanism related to the production of neutralizing antibodies 30 days after vaccination [ Time Frame: 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.

  3. Study on the immune mechanism related to the production of neutralizing antibodies 60 days after vaccination [ Time Frame: 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.

  4. Study on the immune mechanism related to the production of neutralizing antibodies 90 days after vaccination [ Time Frame: 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.

  5. Study on the immune mechanism related to the production of neutralizing antibodies 180 days after vaccination [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with basic diseases vaccinated with SARS-Cov-2 vaccine.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05043246


Contacts
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Contact: DACHUAN M CAI, PH D 18323409779 597521685@qq.com
Contact: DAZHI M ZHANG, PH D 13452382818 dzhzhang@yahoo.com

Locations
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China, Chongqing
The second affiliated Hospital of Chongqing Medical University Recruiting
Chongqing, Chongqing, China, 400010
Contact: DACHUAN M CAI, PH D    18323409779    597521685@qq.com   
Sponsors and Collaborators
The Second Affiliated Hospital of Chongqing Medical University
Investigators
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Principal Investigator: Hong Ren, PH D The Second Affiliated Hospital of Chongqing Medical University
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Responsible Party: Hong Ren, Dr/ Prof., The Second Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier: NCT05043246    
Other Study ID Numbers: 2021-49
First Posted: September 14, 2021    Key Record Dates
Last Update Posted: September 17, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hong Ren, The Second Affiliated Hospital of Chongqing Medical University:
COVID-19
vaccine
elderly population
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases