Safety and Immune Response of COVID-19 Vaccination in Patients With Basic Disease (SIM-PBD)

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.

Study Overview

• Status: Recruiting
• Conditions: Covid19; Adverse Reaction to Vaccine; Diseases, Chronic
• Intervention / Treatment: Biological: SARS-COV-2 VACCINE

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.

• Study Type: Observational
• Enrollment (Anticipated): 2300

Contacts and Locations

• Study Contact: Name: DACHUAN M CAI, PH D; Phone Number: 18323409779; Email: 597521685@qq.com
• Study Contact Backup: Name: DAZHI M ZHANG, PH D; Phone Number: 13452382818; Email: dzhzhang@yahoo.com

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400010
      • Recruiting
      • The Second Affiliated Hospital of Chongqing Medical University
      • Contact: DACHUAN M CAI, PH D; Phone Number: 18323409779; Email: 597521685@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with basic diseases vaccinated with SARS-Cov-2 vaccine.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	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.

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2021
• Primary Completion (ANTICIPATED): May 1, 2023
• Study Completion (ANTICIPATED): August 1, 2023

Study Registration Dates

• First Submitted: August 12, 2021
• First Submitted That Met QC Criteria: September 10, 2021
• First Posted (ACTUAL): September 14, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 10, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: vaccine; COVID-19; basic diseases; cancer diseases
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2021-49

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No