Vaccine HesitancyNCT05532592
Investigation on the Hesitancy of COVID-19 Vaccination Among Liver Transplant Recipients in China
An observational study of Vaccine Hesitancy, run by RenJi Hospital at 1 site in China.
Trial summary
On WeChat platform, through a point-to-point connection, and carry on the questionnaire survey to collect information of liver transplant recipients followed-up by the department of Liver Surgery, Renji Hospital Shanghai Jiao Tong University. Patients meeting inclusion and exclusion criteria will be selected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vaccine Hesitancy
- What is being tested?
- Perceptions and attitudes towards COVID-19 and COVID-19 vaccine
- Type of treatment
- Vaccines
- How many people
- 449 participants
- Where
- 1 siteChina
- Study dates
- 27 Apr 2022to 30 May 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The subjects of this study were adult recipients who were followed up after liver transplantation in the department of Liver Surgery, Renji Hospital Shanghai Jiao Tong University.
Who may be able to join
- age ≥ 18
- recipients after liver transplantation surgery
Who cannot join
- Incomplete data (missing questionnaire information), such as lack of age, gender, indication for transplantation, time after transplantation and other indicators
- loss to follow-up
- COVID-19 vaccination before liver transplantation
Trial locations and contacts
1 site in 1 country.
China1 site
The department of Liver Surgery, Renji Hospital Shanghai Jiao Tong University.
Shanghai, Shanghai Municipality, 200127
About this study
On WeChat platform, through a point-to-point connection, and carry on the questionnaire survey to collect information of liver transplant recipients followed-up by the department of Liver Surgery, Renji Hospital Shanghai Jiao Tong University. Patients meeting inclusion and exclusion criteria will be selected. Conduct statistical analysis to describe the incidence of adverse reactions related to COVID-19 vaccine after liver transplantation, and to compare and evaluate the factors leading to COVID-19 vaccine hesitancy.
Read the detailed description
On WeChat platform, through a point-to-point connection, and carry on the questionnaire survey to collect information of liver transplant recipients followed-up by the department of Liver Surgery, Renji Hospital Shanghai Jiao Tong University. Questionnaire items including demographic characteristics, understanding of COVID-19, attitude toward COVID-19 vaccine. Patients meeting inclusion and exclusion criteria will be selected. Conduct statistical analysis to describe the incidence of adverse reactions related to COVID-19 vaccine after liver transplantation, and to compare and evaluate the factors leading to COVID-19 vaccine hesitancy.
- Conditions
- Vaccine Hesitancy
- Being tested
- Perceptions and attitudes towards COVID-19 and COVID-19 vaccine
- Keywords
- COVID-19, vaccine, vaccine hesitancy, liver transplant recipients, China
- Medical subject headings
- Vaccination Hesitancy, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perceptions and attitudes towards COVID-19 and COVID-19 vaccineOther
Attitude towards COVID-19; Knowledge about COVID-19 vaccine
| Study group | Role | What they receive |
|---|---|---|
| no hesitancy group (NHG) | Participants who got vaccine after transplantation or were willing to be vaccinated. Receives: Other: Perceptions and attitudes towards COVID-19 and COVID-19 vaccine | |
| hesitancy group (HG) | Participants who were uncertain or refused to be vaccinated. Receives: Other: Perceptions and attitudes towards COVID-19 and COVID-19 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with COVID-19 Vaccine Hesitancy
In the questionnaire, participants who expressed hesitancy or explicitly refused to receive the COVID-19 vaccine were considered vaccine hesitancy.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start27 Apr 2022
- Primary completion10 May 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Vaccine HesitancyStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 449 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongbing Qian, RenJi Hospital
- Investigators
- Yongbing Qian, Prof, Study director, The department of Liver Surgery, Renji Hospital Shanghai Jiao Tong University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05532592
- Sponsor's protocol ID
- KY2022-138-B
- Status last verified
- Sep 2022
- First submitted
- 5 Sep 2022
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This retrospective study involves the privacy of the participants. We need to keep it confidential and do not plan to share the data. If you want to know the relevant information, you can contact the principal person in charge of the study
Publications
Azzi Y, Bartash R, Scalea J, Loarte-Campos P, Akalin E. COVID-19 and Solid Organ Transplantation: A Review Article. Transplantation. 2021 Jan 1;105(1):37-55. doi: 10.1097/TP.0000000000003523.
PubMed 33148977Stucchi RSB, Lopes MH, Kumar D, Manuel O. Vaccine Recommendations for Solid-Organ Transplant Recipients and Donors. Transplantation. 2018 Feb;102(2S Suppl 2):S72-S80. doi: 10.1097/TP.0000000000002012. No abstract available.
PubMed 29381581Russo FP, Piano S, Bruno R, Burra P, Puoti M, Masarone M, Montagnese S, Ponziani FR, Petta S, Aghemo A; Italian Association for the Study of the Liver. Italian association for the study of the liver position statement on SARS-CoV2 vaccination. Dig Liver Dis. 2021 Jun;53(6):677-681. doi: 10.1016/j.dld.2021.03.013. Epub 2021 Apr 30.
PubMed 33941488Cornberg 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 33577086Facciola A, Visalli G, Orlando A, Bertuccio MP, Spataro P, Squeri R, Picerno I, Di Pietro A. Vaccine hesitancy: An overview on parents' opinions about vaccination and possible reasons of vaccine refusal. J Public Health Res. 2019 Mar 11;8(1):1436. doi: 10.4081/jphr.2019.1436. eCollection 2019 Mar 11.
PubMed 30997357MacDonald NE; SAGE Working Group on Vaccine Hesitancy. Vaccine hesitancy: Definition, scope and determinants. Vaccine. 2015 Aug 14;33(34):4161-4. doi: 10.1016/j.vaccine.2015.04.036. Epub 2015 Apr 17.
PubMed 25896383Chen T, Li X, Li Q, Huang L, Cai Q, Wang Y, Jiang Y, Xu Q, Lv Q, Wang J. COVID-19 vaccination hesitancy and associated factors among solid organ transplant recipients in China. Hum Vaccin Immunother. 2021 Dec 2;17(12):4999-5006. doi: 10.1080/21645515.2021.1984133. Epub 2021 Sep 29.
PubMed 34586945Costantino A, Invernizzi F, Centorrino E, Vecchi M, Lampertico P, Donato MF. COVID-19 Vaccine Acceptance among Liver Transplant Recipients. Vaccines (Basel). 2021 Nov 11;9(11):1314. doi: 10.3390/vaccines9111314.
PubMed 34835245
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on the Hesitancy of COVID-19 Vaccination Among Liver Transplant Recipients in China
- ClinicalTrials.gov ID
- NCT05532592
- Acronym / sponsor ID
- KY2022-138-B
- Conditions
- Vaccine Hesitancy
- Keywords
- COVID-19, vaccine, vaccine hesitancy, liver transplant recipients, China
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 449 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- 10 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 8 Sep 2022 (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 WeChat platform, through a point-to-point connection, and carry on the questionnaire survey to collect information of liver transplant recipients followed-up by the department of Liver Surgery, Renji Hospital Shanghai Jiao Tong University. Patients meeting inclusion and exclusion criteria will be selected. Conduct statistical analysis to describe the incidence of adverse reactions related to COVID-19 vaccine after liver transplantation, and to compare and evaluate the factors leading to COVID-19 vaccine hesitancy.
Detailed description
On WeChat platform, through a point-to-point connection, and carry on the questionnaire survey to collect information of liver transplant recipients followed-up by the department of Liver Surgery, Renji Hospital Shanghai Jiao Tong University. Questionnaire items including demographic characteristics, understanding of COVID-19, attitude toward COVID-19 vaccine. Patients meeting inclusion and exclusion criteria will be selected. Conduct statistical analysis to describe the incidence of adverse reactions related to COVID-19 vaccine after liver transplantation, and to compare and evaluate the factors leading to COVID-19 vaccine hesitancy.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no hesitancy group (NHG) | – | Other: Perceptions and attitudes towards COVID-19 and COVID-19 vaccineParticipants who got vaccine after transplantation or were willing to be vaccinated. |
| hesitancy group (HG) | – | Other: Perceptions and attitudes towards COVID-19 and COVID-19 vaccineParticipants who were uncertain or refused to be vaccinated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects of this study were adult recipients who were followed up after liver transplantation in the department of Liver Surgery, Renji Hospital Shanghai Jiao Tong University.
Key inclusion criteria (2 listed)
- age ≥ 18
- recipients after liver transplantation surgery
Key exclusion criteria (3 listed)
- Incomplete data (missing questionnaire information), such as lack of age, gender, indication for transplantation, time after transplantation and other indicators
- loss to follow-up
- COVID-19 vaccination before liver transplantation
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 |
|---|---|---|
| Perceptions and attitudes towards COVID-19 and COVID-19 vaccineAttitude towards COVID-19; Knowledge about COVID-19 vaccine | Other | hesitancy group (HG), no hesitancy group (NHG) |
Primary outcome
Number of Participants with COVID-19 Vaccine Hesitancy
Time frame: through study completion, an average of 1 year
In the questionnaire, participants who expressed hesitancy or explicitly refused to receive the COVID-19 vaccine were considered vaccine hesitancy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Background: PubMed 33148977Azzi Y, Bartash R, Scalea J, Loarte-Campos P, Akalin E. COVID-19 and Solid Organ Transplantation: A Review Article. Transplantation. 2021 Jan 1;105(1):37-55. doi: 10.1097/TP.0000000000003523.
- Background: PubMed 29381581Stucchi RSB, Lopes MH, Kumar D, Manuel O. Vaccine Recommendations for Solid-Organ Transplant Recipients and Donors. Transplantation. 2018 Feb;102(2S Suppl 2):S72-S80. doi: 10.1097/TP.0000000000002012. No abstract available.
- Background: PubMed 33941488Russo FP, Piano S, Bruno R, Burra P, Puoti M, Masarone M, Montagnese S, Ponziani FR, Petta S, Aghemo A; Italian Association for the Study of the Liver. Italian association for the study of the liver position statement on SARS-CoV2 vaccination. Dig Liver Dis. 2021 Jun;53(6):677-681. doi: 10.1016/j.dld.2021.03.013. Epub 2021 Apr 30.
- Background: 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.
- Background: 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.
- Background: PubMed 30997357Facciola A, Visalli G, Orlando A, Bertuccio MP, Spataro P, Squeri R, Picerno I, Di Pietro A. Vaccine hesitancy: An overview on parents' opinions about vaccination and possible reasons of vaccine refusal. J Public Health Res. 2019 Mar 11;8(1):1436. doi: 10.4081/jphr.2019.1436. eCollection 2019 Mar 11.
- Background: PubMed 25896383MacDonald NE; SAGE Working Group on Vaccine Hesitancy. Vaccine hesitancy: Definition, scope and determinants. Vaccine. 2015 Aug 14;33(34):4161-4. doi: 10.1016/j.vaccine.2015.04.036. Epub 2015 Apr 17.
- Background: PubMed 34586945Chen T, Li X, Li Q, Huang L, Cai Q, Wang Y, Jiang Y, Xu Q, Lv Q, Wang J. COVID-19 vaccination hesitancy and associated factors among solid organ transplant recipients in China. Hum Vaccin Immunother. 2021 Dec 2;17(12):4999-5006. doi: 10.1080/21645515.2021.1984133. Epub 2021 Sep 29.
- Background: PubMed 34835245Costantino A, Invernizzi F, Centorrino E, Vecchi M, Lampertico P, Donato MF. COVID-19 Vaccine Acceptance among Liver Transplant Recipients. Vaccines (Basel). 2021 Nov 11;9(11):1314. doi: 10.3390/vaccines9111314.
- World Health Organization (WHO). Draft landscape of COVID-19 candidate vaccines. 2021 June 15.Link provided by the sponsor.
- Individual participant dataSharing planned: No. This retrospective study involves the privacy of the participants. We need to keep it confidential and do not plan to share the data. If you want to know the relevant information, you can contact the principal person in charge of the study
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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.
Yongbing Qian, Prof study director
The department of Liver Surgery, Renji Hospital Shanghai Jiao Tong 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 Vaccine Hesitancy, run by RenJi 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 8 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with COVID-19 Vaccine Hesitancy (time frame: through study completion, an average of 1 year). 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 NCT05532592, which also lists 9 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 8 Sep 2022.