Clinical trial · Observational
Safety and Immune Response of COVID-19 Vaccination in Patients With Basic Disease
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adverse Reaction to Vaccine | — | UNRESOLVED | — |
| Covid19 | — | UNRESOLVED | — |
| Diseases, Chronic | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SARS-COV-2 VACCINE | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Basic diseases Patients/Healthy People
- description
- Hypertension, diabetes, chronic obstructive pulmonary disease, chronic kidney disease,Chronic Liver Diseases, Cancer diseases Patients
- interventionNames
- Biological: SARS-COV-2 VACCINE
Primary outcomes (10)
- measure
- Number of participants with adverse events 15 days after vaccination
- timeFrame
- 15 days：Record the number of adverse reactions such as fever, dizziness, nausea, headache, fatigue, myalgia, etc.
- description
- 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.
- measure
- Number of participants with adverse events 30 days after vaccination
- timeFrame
- 30 days:Record the number of adverse reactions such as fever, dizziness, nausea, headache, fatigue, myalgia, etc.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (3)
- DERIVEDYang 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
- DERIVEDXiang 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
- DERIVEDGuo 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