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

NCT ID: NCT05043246

Last Updated: 2022-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-01

Study Completion Date

2023-08-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diseases, Chronic Covid19 Adverse Reaction to Vaccine

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Basic diseases Patients/Healthy People

Hypertension, diabetes, chronic obstructive pulmonary disease, chronic kidney disease,Chronic Liver Diseases, Cancer diseases Patients

SARS-COV-2 VACCINE

Intervention Type BIOLOGICAL

the antibody titer and adverse reactions were observed.

Interventions

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SARS-COV-2 VACCINE

the antibody titer and adverse reactions were observed.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Second Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Hong Ren

Dr/ Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hong Ren, PH D

Role: PRINCIPAL_INVESTIGATOR

The Second Affiliated Hospital of Chongqing Medical University

Locations

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The second affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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DACHUAN M CAI, PH D

Role: CONTACT

18323409779

DAZHI M ZHANG, PH D

Role: CONTACT

13452382818

Facility Contacts

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DACHUAN M CAI, PH D

Role: primary

18323409779

References

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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.

Reference Type DERIVED
PMID: 36849838 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36750902 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36620297 (View on PubMed)

Other Identifiers

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2021-49

Identifier Type: -

Identifier Source: org_study_id

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