Diseases, ChronicSIM-PBDNCT05043246
Safety and Immune Response of COVID-19 Vaccination in Patients With Basic Disease
An observational study of Diseases, Chronic and Covid19, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diseases, Chronic, Covid19, Adverse Reaction to Vaccine
- What is being tested?
- SARS-COV-2 VACCINE
- Type of treatment
- Vaccines
- How many people
- 2,300 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2021to 1 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with basic diseases vaccinated with SARS-Cov-2 vaccine.
Who may be able to join
- The selection criteria should follow the disease diagnosis guidelines developed by various colleges and the consensus of expert recommendations on vaccination.
Who cannot join
- The exclusion criteria should follow the disease diagnosis guidelines developed by various colleges and the consensus of expert recommendations on vaccination.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The second affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
DACHUAN M CAI, PH D, 18323409779, 597521685@qq.com
About this study
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.
Read the 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.
- Conditions
- Diseases, Chronic, Covid19, Adverse Reaction to Vaccine
- Being tested
- SARS-COV-2 VACCINE
- Keywords
- COVID-19, vaccine, basic diseases, cancer diseases
- Medical subject headings
- Chronic Disease, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-COV-2 VACCINEBiological
the antibody titer and adverse reactions were observed.
| Study group | Role | What they receive |
|---|---|---|
| Basic diseases Patients/Healthy People | Hypertension, diabetes, chronic obstructive pulmonary disease, chronic kidney disease,Chronic Liver Diseases, Cancer diseases Patients Receives: Biological: SARS-COV-2 VACCINE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 180 days：Detect the levels of B cells and related subgroups, Treg and CTL
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start1 Aug 2021
- Primary completion1 May 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diseases, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Ren, The Second Affiliated Hospital of Chongqing Medical University
- Investigators
- Hong Ren, PH D, Principal investigator, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05043246
- Sponsor's protocol ID
- 2021-49
- Acronym
- SIM-PBD
- Status last verified
- Aug 2022
- First submitted
- 12 Aug 2021
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36849838Xiang 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.
PubMed 36750902Guo 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.
PubMed 36620297
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immune Response of COVID-19 Vaccination in Patients With Basic Disease
- ClinicalTrials.gov ID
- NCT05043246
- Acronym / sponsor ID
- SIM-PBD / 2021-49
- Conditions
- Diseases, Chronic, Covid19, Adverse Reaction to Vaccine
- Keywords
- COVID-19, vaccine, basic diseases, cancer diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,300 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 14 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Basic diseases Patients/Healthy People | – | Biological: SARS-COV-2 VACCINEHypertension, diabetes, chronic obstructive pulmonary disease, chronic kidney disease,Chronic Liver Diseases, Cancer diseases Patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with basic diseases vaccinated with SARS-Cov-2 vaccine.
Key inclusion criteria (1 listed)
- The selection criteria should follow the disease diagnosis guidelines developed by various colleges and the consensus of expert recommendations on vaccination.
Key exclusion criteria (1 listed)
- The exclusion criteria should follow the disease diagnosis guidelines developed by various colleges and the consensus of expert recommendations on vaccination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SARS-COV-2 VACCINEthe antibody titer and adverse reactions were observed. | Biological | Basic diseases Patients/Healthy People |
Primary outcome
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.
5 secondary outcomes
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Derived from this study: PubMed 36849838Yang 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.
- Derived from this study: PubMed 36750902Xiang 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.
- Derived from this study: PubMed 36620297Guo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hong Ren, PH D principal investigator
The Second Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diseases, Chronic and Covid19, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DACHUAN M CAI, PH D (18323409779, 597521685@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05043246, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.