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

NCT05043246 | Unknown

• 1 other identifier: 2021-49
• Study Type: observational
• Target: 2,300
• Locations: 1 country
• Sites: 1

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.

Conditions

Diseases, Chronic; Covid19; Adverse Reaction to Vaccine

Keywords

COVID-19; vaccine; basic diseases; cancer diseases

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

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

Interventions

SARS-COV-2 VACCINE BIOLOGICAL

the antibody titer and adverse reactions were observed.

Basic diseases Patients/Healthy People

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The second affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

RECRUITING

Related Publications (3)

• Yang L, Xiang F, Wang D, Guo Q, Deng B, Jiang D, Ren H. The safety and immunogenicity of inactivated COVID-19 vaccine in old pulmonary tuberculosis patients. Eur J Clin Microbiol Infect Dis. 2023 Apr;42(4):503-512. doi: 10.1007/s10096-023-04566-0. Epub 2023 Feb 28.

  PMID: 36849838 DERIVED

• Xiang F, Long B, He J, Cheng F, Zhang S, Liu Q, Chen Z, Li H, Chen M, Peng M, Yin W, Liu D, Ren H. Impaired antibody responses were observed in patients with type 2 diabetes mellitus after receiving the inactivated COVID-19 vaccines. Virol J. 2023 Feb 7;20(1):22. doi: 10.1186/s12985-023-01983-7.

  PMID: 36750902 DERIVED

• Guo Q, Yang L, Peng R, Gao T, Chu X, Jiang D, Ke D, Ren H. Safety and immunogenicity of inactivated COVID-19 vaccine in patients with metabolic syndrome: A cross-sectional observational study. Front Public Health. 2022 Dec 23;10:1067342. doi: 10.3389/fpubh.2022.1067342. eCollection 2022.

  PMID: 36620297 DERIVED

MeSH Terms

Conditions

Chronic Disease; COVID-19

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Hong Ren, PH D

  The Second Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

DACHUAN M CAI, PH D

CONTACT

18323409779; 597521685@qq.com

DAZHI M ZHANG, PH D

CONTACT

13452382818; dzhzhang@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr/ Prof.

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: September 14, 2021
• Study Start: August 1, 2021
• Primary Completion: May 1, 2023
• Study Completion: August 1, 2023
• Last Updated: August 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)