Liver Disease ChronicNCT05017805
COVID-19 Vaccines in Patients With Chronic Liver Disease
A study testing COVID-19 Vaccines in people with Liver Disease Chronic, run by Beijing 302 Hospital at 1 site in China.
Trial summary
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused pandemic since outbreak in 2020.Patients with chronic liver disease (CLD) are at higher risk of mortality and morbidity due to COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Disease Chronic
- What is being tested?
- COVID-19 Vaccines
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2021to 15 Aug 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Serum ALT and AST are both ≤ 80 U/L.
- HIV and TPHA screening were negative.
- Body temperature ≤37.0℃.
Who cannot join
- Patients who confirmed the diagnosis of liver cancer by imaging examination (CT/MRI/B scan).
- Patients who are allergic to any component of the vaccine, or have a serious history of vaccine allergy.
- Women who is pregnant, breastfeeding, or planning to be pregnant within 6 months.
- Patients with cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, and severe hypertension can not be well controlled by drugs.
- Patients with severe chronic diseases or diseases can not be controlled well during the progress, such as asthma, diabetes, thyroid disease, etc. Congenital or acquired angioedema / neuroedema.c.
- Patients with urticaria within a year.
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- Patients with coagulation disorder.
- Faintng during acupuncture treatment .
- Patients who received other investigational drugs within one month.
- Be receiving anti-TB treatment.
- Other conditions determined by the researcher.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, 100039
Fu-Sheng Wang, MD, 01066933328, fswang302@163.com
Fu-Sheng Wang, Principal Investigator
About this study
Official title: Safety and Immunogenicity of COVID-19 Vaccines in Patients With Chronic Liver Disease: A Multi-center Prospective Study
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused pandemic since outbreak in 2020.Patients with chronic liver disease (CLD) are at higher risk of mortality and morbidity due to COVID-19. Despite there is a large number of clinical trials of COVID-19 vaccines, only a few participants with chronic liver diseases were included.
Read the detailed description
This study is a prospective, open-label clinical trial. A total of 300 patients with different cancers including chronic hepatitis, cirrhosis .All of the patients will further accept 18 months follow-up study after vaccination. Safety and immunogenicity will be carefully recorded and detected.
- Conditions
- Liver Disease Chronic
- Being tested
- COVID-19 Vaccines
- Keywords
- Liver Disease Chronic, COVID-19 vaccination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 VaccinesBiological
One dose (0.5 mL) of coronavirus vaccine was inoculated on day 0 and day 25±3, respectively.
| Study group | Role | What they receive |
|---|---|---|
| 3 doses of vaccine | Experimental | Covid-19 vaccination on day 0, day 25±3, and 6 months after the second dose , respectively，and follow up one and half a year Receives: Biological: COVID-19 Vaccines |
| 1 dose of the third vaccination | Experimental | One dose of COVID-19 vaccine and 1 year of follow-up Receives: Biological: COVID-19 Vaccines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of coronavirus vaccine
Rate of adverse effects after COVID-19 vaccination
Measured: Within 2 months after the first dose of COVID-19 vaccination
Immunogenicity of coronavirus vaccine
Detected the dynamics and titers of anti-SARS-CoV-2 antibodies
Measured: Within 2 months after the first dose of COVID-19 vaccination
Secondary outcomes (2)
Safety of coronavirus vaccine
Rate of adverse effects after COVID-19 vaccination
Measured: Within 18 months after the first dose of COVID-19 vaccination
Immunogenicity of coronavirus vaccine
Detected the dynamics and titers of anti-SARS-CoV-2 antibodies
Measured: Within 18 months after the first dose of COVID-19 vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start15 Aug 2021
- Primary completion15 Aug 2024 (estimated)
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver Disease 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing 302 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017805
- Sponsor's protocol ID
- ky-2021-7-8-1
- Status last verified
- Aug 2021
- First submitted
- 12 Aug 2021
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cornberg M, Buti M, Eberhardt CS, Grossi PA, Shouval D. EASL position paper on the use of COVID-19 vaccines in patients with chronic liver diseases, hepatobiliary cancer and liver transplant recipients. J Hepatol. 2021 Apr;74(4):944-951. doi: 10.1016/j.jhep.2021.01.032. Epub 2021 Feb 6.
PubMed 33563499Fix OK, Blumberg EA, Chang KM, Chu J, Chung RT, Goacher EK, Hameed B, Kaul DR, Kulik LM, Kwok RM, McGuire BM, Mulligan DC, Price JC, Reau NS, Reddy KR, Reynolds A, Rosen HR, Russo MW, Schilsky ML, Verna EC, Ward JW, Fontana RJ; AASLD COVID-19 Vaccine Working Group. American Association for the Study of Liver Diseases Expert Panel Consensus Statement: Vaccines to Prevent Coronavirus Disease 2019 Infection in Patients With Liver Disease. Hepatology. 2021 Aug;74(2):1049-1064. doi: 10.1002/hep.31751.
PubMed 33577086
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of COVID-19 Vaccines in Patients With Chronic Liver Disease: A Multi-center Prospective Study
- ClinicalTrials.gov ID
- NCT05017805
- Acronym / sponsor ID
- ky-2021-7-8-1
- Conditions
- Liver Disease Chronic
- Keywords
- Liver Disease Chronic, COVID-19 vaccination
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Beijing 302 HospitalUniversity, hospital or other
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 15 Aug 2024 (estimated)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 24 Aug 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.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused pandemic since outbreak in 2020.Patients with chronic liver disease (CLD) are at higher risk of mortality and morbidity due to COVID-19. Despite there is a large number of clinical trials of COVID-19 vaccines, only a few participants with chronic liver diseases were included.
Detailed description
This study is a prospective, open-label clinical trial. A total of 300 patients with different cancers including chronic hepatitis, cirrhosis .All of the patients will further accept 18 months follow-up study after vaccination. Safety and immunogenicity will be carefully recorded and detected.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 doses of vaccine | Experimental | Biological: COVID-19 VaccinesCovid-19 vaccination on day 0, day 25±3, and 6 months after the second dose , respectively，and follow up one and half a year |
| 1 dose of the third vaccination | Experimental | Biological: COVID-19 VaccinesOne dose of COVID-19 vaccine and 1 year of follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- Serum ALT and AST are both ≤ 80 U/L.
- HIV and TPHA screening were negative.
- Body temperature ≤37.0℃.
Key exclusion criteria (11 listed)
- Patients who confirmed the diagnosis of liver cancer by imaging examination (CT/MRI/B scan).
- Patients who are allergic to any component of the vaccine, or have a serious history of vaccine allergy.
- Women who is pregnant, breastfeeding, or planning to be pregnant within 6 months.
- Patients with cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, and severe hypertension can not be well controlled by drugs.
- Patients with severe chronic diseases or diseases can not be controlled well during the progress, such as asthma, diabetes, thyroid disease, etc. Congenital or acquired angioedema / neuroedema.c.
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 |
|---|---|---|
| COVID-19 VaccinesOne dose (0.5 mL) of coronavirus vaccine was inoculated on day 0 and day 25±3, respectively. | Biological | 1 dose of the third vaccination, 3 doses of vaccine |
Primary outcome
Safety of coronavirus vaccine
Time frame: Within 2 months after the first dose of COVID-19 vaccination
Rate of adverse effects after COVID-19 vaccination
Immunogenicity of coronavirus vaccine
Time frame: Within 2 months after the first dose of COVID-19 vaccination
Detected the dynamics and titers of anti-SARS-CoV-2 antibodies
2 secondary outcomes
Safety of coronavirus vaccine
Time frame: Within 18 months after the first dose of COVID-19 vaccination
Immunogenicity of coronavirus vaccine
Time frame: Within 18 months after the first dose of COVID-19 vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Results publication: PubMed 33563499Cornberg M, Buti M, Eberhardt CS, Grossi PA, Shouval D. EASL position paper on the use of COVID-19 vaccines in patients with chronic liver diseases, hepatobiliary cancer and liver transplant recipients. J Hepatol. 2021 Apr;74(4):944-951. doi: 10.1016/j.jhep.2021.01.032. Epub 2021 Feb 6.
- Results publication: PubMed 33577086Fix OK, Blumberg EA, Chang KM, Chu J, Chung RT, Goacher EK, Hameed B, Kaul DR, Kulik LM, Kwok RM, McGuire BM, Mulligan DC, Price JC, Reau NS, Reddy KR, Reynolds A, Rosen HR, Russo MW, Schilsky ML, Verna EC, Ward JW, Fontana RJ; AASLD COVID-19 Vaccine Working Group. American Association for the Study of Liver Diseases Expert Panel Consensus Statement: Vaccines to Prevent Coronavirus Disease 2019 Infection in Patients With Liver Disease. Hepatology. 2021 Aug;74(2):1049-1064. doi: 10.1002/hep.31751.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COVID-19 Vaccines in people with Liver Disease Chronic, run by Beijing 302 Hospital 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 4 inclusion and 11 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 22 Apr 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of coronavirus vaccine (time frame: Within 2 months after the first dose of COVID-19 vaccination). The study lists 2 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 NCT05017805, which also lists 2 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 22 Apr 2022.