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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

Tracking Information
First Submitted Date August 12, 2021
First Posted Date September 14, 2021
Last Update Posted Date September 17, 2021
Actual Study Start Date August 1, 2021
Estimated Primary Completion Date May 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 10, 2021)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 10, 2021)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Safety and Immune Response of COVID-19 Vaccination in Middle-aged and Elderly Patients With Basic Disease
Official Title Safety and Immune Response of COVID-19 Vaccination in Middle-aged and Elderly Patients With Basic Disease
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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with basic diseases vaccinated with SARS-Cov-2 vaccine.
Condition
  • Diseases, Chronic
  • Covid19
  • Adverse Reaction to Vaccine
Intervention Biological: SARS-COV-2 VACCINE
the antibody titer and adverse reactions were observed.
Study Groups/Cohorts Basic diseases Patients/Healthy People
Hypertension, diabetes, chronic obstructive pulmonary disease, chronic kidney disease,Chronic Liver Diseases Patients
Intervention: Biological: SARS-COV-2 VACCINE
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 10, 2021)
2300
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 1, 2022
Estimated Primary Completion Date May 1, 2022   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 60 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: DACHUAN M CAI, PH D 18323409779 597521685@qq.com
Contact: DAZHI M ZHANG, PH D 13452382818 dzhzhang@yahoo.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT05043246
Other Study ID Numbers 2021-49
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Hong Ren, The Second Affiliated Hospital of Chongqing Medical University
Study Sponsor The Second Affiliated Hospital of Chongqing Medical University
Collaborators Not Provided
Investigators
Principal Investigator: Hong Ren, PH D The Second Affiliated Hospital of Chongqing Medical University
PRS Account The Second Affiliated Hospital of Chongqing Medical University
Verification Date September 2021