COVID-19 VaccinesNCT05831826
Effectiveness and Safety of the Inactivated COVID-19 Vaccine in Thousands of Patients With Autoimmune Diseases in China
An observational study of COVID-19 Vaccines and Autoimmune Diseases, run by Zhejiang Chinese Medical University at 1 site in China.
Trial summary
According to the comprehensive evaluation, the completion of vaccination and the prevention and treatment strategy of integrated traditional Chinese and western medicine have obvious advantages in improving the symptoms of infection in patients with autoimmune diseases, shortening the course of disease and controlling… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Vaccines, Autoimmune Diseases
- What is being tested?
- the inactivated COVID-19 vaccines
- Type of treatment
- Vaccines
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2020to Dec 2024
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with ADs (≥18 years old) were recruited into the study according to the following inclusion criteria: rheumatoid arthritis (RA) / American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2010 classification criteria; ankylosing spondylitis (AS) / the 1984 modified New York criteria; systemic lupus erythematosus (SLE) / 2019 EULAR/ACR classification criteria; Sjögren's Syndrome (SS) / 2016 ACR/EULAR Classification Criteria; systemic vasculitis. Patients were instructed to continue taking all drugs during the vaccination period, except for biotherapy that was delayed after the vaccination by physician's suggestion. The HC were healthy volunteers who did not receive immunosuppressive therapy.
Who may be able to join
- ≥18 years old
- The ADs group were diagnosed with autoimmune diseases according to the following inclusion criteria: rheumatoid arthritis (RA) / American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2010 classification criteria; ankylosing spondylitis (AS) / the 1984 modified New York criteria; systemic lupus erythematosus (SLE) / 2019 EULAR/ACR classification criteria; Sjögren's Syndrome (SS) / 2016 ACR/EULAR Classification Criteria; systemic vasculitis / Chapel Hill Consensus Conference definitions; idiopathic inflammatory myositis (IIM) / 2017 EULAR/ACR classification criteria; psoriatic arthritis (PsA) / 2006 Classification Criteria for PsA; systemic sclerosis (SSc) / 2013 ACR/EULAR collaborative initiative; polymyalgia rheumatica (PMR) / 2012 provisional classification criteria.
- The HC group were volunteers who did not have history of autoimmune diseases and did not receive immunosuppressive therapy.
Who cannot join
- history of COVID-19 infection
- history of vaccination allergy
- history of mental disabilities
- pregnancy
- unwillingness to sign informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Zhejiang Chinese Medicine University
Hangzhou, Zhejiang
Wumeng Jin, jwm8956@126.com
About this study
Official title: Multicenter Clinical and Basic Research on the Prevention and Treatment of 2019-nCoV by Integrated Traditional Chinese and Western Medicine
According to the comprehensive evaluation, the completion of vaccination and the prevention and treatment strategy of integrated traditional Chinese and western medicine have obvious advantages in improving the symptoms of infection in patients with autoimmune diseases, shortening the course of disease and controlling disease activity, and can play a positive role in the whole process of epidemic prevention and treatment. Now the investigators plan to conduct multi-center clinical and basic research to observe the preventive effect and safety of the vaccine on COVID-19, as well as the preventive effect of the combination of traditional Chinese medicine, in order to obtain high-quality evidence-based evidence and provide scientific basis for the clinical value of the drug.
Read the detailed description
Autoimmune diseases are disorders of the body's immune function, involving multiple organs and tissues of the whole body, and characterized by a variety of specific or non-specific autoantibodies and inflammatory factors overexpression. However, during the global COVID-19 pandemic, patients with autoimmune diseases, especially those receiving immunosuppressive therapy, face a high burden of novel coronavirus pneumonia (COVID-19) and are at higher risk for severe infection and disease progression. At present, patients with autoimmune diseases should give priority to the prevention and treatment strategy of COVID-19, among which the vaccination of novel coronavirus vaccine is the most important means to actively build herd immunity and control the epidemic of novel coronavirus pneumonia, and the combination of traditional Chinese and western medicine is an essential and effective way to prevent and treat COVID-19 infection. According to the comprehensive evaluation, the completion of vaccination and the prevention and treatment strategy of integrated traditional Chinese and western medicine have obvious advantages in improving the symptoms of infection in patients with autoimmune diseases, shortening the course of disease and controlling disease activity, and can play a positive role in the whole process of epidemic prevention and treatment. Now the investigators plan to conduct multi-center clinical and basic research to observe the preventive effect and safety of the vaccine on COVID-19, as well as the preventive effect of the combination of traditional Chinese medicine, in order to obtain high-quality evidence-based evidence and provide scientific basis for the clinical value of the drug.
- Conditions
- COVID-19 Vaccines, Autoimmune Diseases
- Being tested
- the inactivated COVID-19 vaccines
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the inactivated COVID-19 vaccinesBiological
receive the doses of inactivated COVID-19 vaccines
| Study group | Role | What they receive |
|---|---|---|
| healthy controls | Healthy controls are ≥18 years old, no previous history of SARS-CoV-2 infection, and no previous history of autoimmune diseases. All the HC group were injected with 2 or 3 doses of inactivated SARS-CoV-2 vaccines. Receives: Biological: the inactivated COVID-19 vaccines | |
| the vaccinated patients with ADs | The vaccinated patients with ADs are ≥18 years old, no previous history of SARS-CoV-2 infection, and diagnosed with autoimmune diseases. All the group were injected with the inactivated SARS-CoV-2 vaccines. Receives: Biological: the inactivated COVID-19 vaccines | |
| the unvaccinated patients with ADs | The vaccinated patients with ADs are ≥18 years old, no previous history of SARS-CoV-2 infection, and diagnosed with autoimmune diseases. All the group were not injected with the inactivated SARS-CoV-2 vaccines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of local and systemic adverse events
One of the primary end point was the safety of the inactivated COVID-19 vaccine in adult patients with ADs compared with controls.
Measured: 3 years
Concentration of anti-SARS-CoV-2 spike protein
One of the primary end point was the immunogenicity of the inactivated COVID-19 vaccine in adult patients with ADs compared with controls.
Measured: 3 years
Infection rate of COVID-19
One of the primary end point was the efficacy of the inactivated COVID-19 vaccine in adult patients with ADs.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start1 Jun 2020
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 VaccinesStudies 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
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Chinese Medical University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Chengping Wen, Zhejiang Chinese Medical University
- Investigators
- Wumeng Jin, Principal investigator, Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05831826
- Sponsor's protocol ID
- ZhejiangCMU 2020-KL-0601-1
- Status last verified
- Oct 2023
- First submitted
- 25 Apr 2023
- Last updated
- 24 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Clinical and Basic Research on the Prevention and Treatment of 2019-nCoV by Integrated Traditional Chinese and Western Medicine
- ClinicalTrials.gov ID
- NCT05831826
- Acronym / sponsor ID
- ZhejiangCMU 2020-KL-0601-1
- Conditions
- COVID-19 Vaccines, Autoimmune Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Zhejiang Chinese Medical UniversityOther government
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 26 Apr 2023 (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.
According to the comprehensive evaluation, the completion of vaccination and the prevention and treatment strategy of integrated traditional Chinese and western medicine have obvious advantages in improving the symptoms of infection in patients with autoimmune diseases, shortening the course of disease and controlling disease activity, and can play a positive role in the whole process of epidemic prevention and treatment. Now the investigators plan to conduct multi-center clinical and basic research to observe the preventive effect and safety of the vaccine on COVID-19, as well as the preventive effect of the combination of traditional Chinese medicine, in order to obtain high-quality evidence-based evidence and provide scientific basis for the clinical value of the drug.
Detailed description
Autoimmune diseases are disorders of the body's immune function, involving multiple organs and tissues of the whole body, and characterized by a variety of specific or non-specific autoantibodies and inflammatory factors overexpression. However, during the global COVID-19 pandemic, patients with autoimmune diseases, especially those receiving immunosuppressive therapy, face a high burden of novel coronavirus pneumonia (COVID-19) and are at higher risk for severe infection and disease progression. At present, patients with autoimmune diseases should give priority to the prevention and treatment strategy of COVID-19, among which the vaccination of novel coronavirus vaccine is the most important means to actively build herd immunity and control the epidemic of novel coronavirus pneumonia, and the combination of traditional Chinese and western medicine is an essential and effective way to prevent and treat COVID-19 infection. According to the comprehensive evaluation, the completion of vaccination and the prevention and treatment strategy of integrated traditional Chinese and western medicine have obvious advantages in improving the symptoms of infection in patients with autoimmune diseases, shortening the course of disease and controlling disease activity, and can play a positive role in the whole process of epidemic prevention and treatment. Now the investigators plan to conduct multi-center clinical and basic research to observe the preventive effect and safety of the vaccine on COVID-19, as well as the preventive effect of the combination of traditional Chinese medicine, in order to obtain high-quality evidence-based evidence and provide scientific basis for the clinical value of the drug.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| healthy controls | – | Biological: the inactivated COVID-19 vaccinesHealthy controls are ≥18 years old, no previous history of SARS-CoV-2 infection, and no previous history of autoimmune diseases. All the HC group were injected with 2 or 3 doses of inactivated SARS-CoV-2 vaccines. |
| the vaccinated patients with ADs | – | Biological: the inactivated COVID-19 vaccinesThe vaccinated patients with ADs are ≥18 years old, no previous history of SARS-CoV-2 infection, and diagnosed with autoimmune diseases. All the group were injected with the inactivated SARS-CoV-2 vaccines. |
| the unvaccinated patients with ADs | – | –The vaccinated patients with ADs are ≥18 years old, no previous history of SARS-CoV-2 infection, and diagnosed with autoimmune diseases. All the group were not injected with the inactivated SARS-CoV-2 vaccines. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ADs (≥18 years old) were recruited into the study according to the following inclusion criteria: rheumatoid arthritis (RA) / American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2010 classification criteria; ankylosing spondylitis (AS) / the 1984 modified New York criteria; systemic lupus erythematosus (SLE) / 2019 EULAR/ACR classification criteria; Sjögren's Syndrome (SS) / 2016 ACR/EULAR Classification Criteria; systemic vasculitis. Patients were instructed to continue taking all drugs during the vaccination period, except for biotherapy that was delayed after the vaccination by physician's suggestion. The HC were healthy volunteers who did not receive immunosuppressive therapy.
Key inclusion criteria (3 listed)
- ≥18 years old
- The ADs group were diagnosed with autoimmune diseases according to the following inclusion criteria: rheumatoid arthritis (RA) / American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2010 classification criteria; ankylosing spondylitis (AS) / the 1984 modified New York criteria; systemic lupus erythematosus (SLE) / 2019 EULAR/ACR classification criteria; Sjögren's Syndrome (SS) / 2016 ACR/EULAR Classification Criteria; systemic vasculitis / Chapel Hill Consensus Conference definitions; idiopathic inflammatory myositis (IIM) / 2017 EULAR/ACR classification criteria; psoriatic arthritis (PsA) / 2006 Classification Criteria for PsA; systemic sclerosis (SSc) / 2013 ACR/EULAR collaborative initiative; polymyalgia rheumatica (PMR) / 2012 provisional classification criteria.
- The HC group were volunteers who did not have history of autoimmune diseases and did not receive immunosuppressive therapy.
Key exclusion criteria (5 listed)
- history of COVID-19 infection
- history of vaccination allergy
- history of mental disabilities
- pregnancy
- unwillingness to sign informed consent.
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 |
|---|---|---|
| the inactivated COVID-19 vaccinesreceive the doses of inactivated COVID-19 vaccines | Biological | healthy controls, the vaccinated patients with ADs |
Primary outcome
Incidence of local and systemic adverse events
Time frame: 3 years
One of the primary end point was the safety of the inactivated COVID-19 vaccine in adult patients with ADs compared with controls.
Concentration of anti-SARS-CoV-2 spike protein
Time frame: 3 years
One of the primary end point was the immunogenicity of the inactivated COVID-19 vaccine in adult patients with ADs compared with controls.
Infection rate of COVID-19
Time frame: 3 years
One of the primary end point was the efficacy of the inactivated COVID-19 vaccine in adult patients with ADs.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
Related trials for COVID-19 Vaccines
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Active, not recruitingObservational study
SCIVAX: Biomarkers of Immune Dysfunction and Vaccine Responsiveness in Chronic SCI
Spinal Cord Injuries, Traumatic Spinal Cord Injury
RecruitingPhase 4
A Study to Investigate the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Formulations
SARS-CoV-2
Active, not recruitingObservational study
Vaccine Responses to SARS-CoV-2 and Other Emerging Infectious Diseases
COVID-19, Vaccination
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.
Wumeng Jin principal investigator
Zhejiang Chinese 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 COVID-19 Vaccines and Autoimmune Diseases, run by Zhejiang Chinese 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 3 inclusion and 5 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 24 Oct 2023. 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 Wumeng Jin (+8615824198956, jwm8956@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of local and systemic adverse events (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Oct 2023.