CClinicalTrials.gg
CompletedNCT05532592Updated Sep 8, 2022

Investigation on the Hesitancy of COVID-19 Vaccination Among Liver Transplant Recipients in China

An observational study in Vaccine Hesitancy, sponsored by RenJi Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-08.

Sponsored by RenJi Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
449
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Vaccine Hesitancy

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Keywords

  • COVID-19
  • vaccine
  • vaccine hesitancy
  • liver transplant recipients
  • China
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 449 is above the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  1. age ≥ 18
  2. recipients after liver transplantation surgery

Exclusion criteria

Exclusion Criteria:

  1. Incomplete data (missing questionnaire information), such as lack of age, gender, indication for transplantation, time after transplantation and other indicators
  2. loss to follow-up
  3. COVID-19 vaccination before liver transplantation
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
449 participants (actual)
Patient registry
No

Groups and cohorts

  • no hesitancy group (NHG)

    Participants who got vaccine after transplantation or were willing to be vaccinated.

    Other: Perceptions and attitudes towards COVID-19 and COVID-19 vaccine

  • hesitancy group (HG)

    Participants who were uncertain or refused to be vaccinated.

    Other: Perceptions and attitudes towards COVID-19 and COVID-19 vaccine

Interventions

  • OtherPerceptions and attitudes towards COVID-19 and COVID-19 vaccine

    Attitude towards COVID-19; Knowledge about COVID-19 vaccine

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: through study completion, an average of 1 year

07

Study locations

1 site
  • The department of Liver Surgery, Renji Hospital Shanghai Jiao Tong University.
    Shanghai, Shanghai 200127, China
08

References and documents

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 33148977 ↗
  • Stucchi 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 29381581 ↗
  • Russo 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 33941488 ↗
  • 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 33563499 ↗
  • Fix 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 ↗
  • Facciola 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 30997357 ↗
  • MacDonald 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 25896383 ↗
  • Chen 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 34586945 ↗
  • Costantino 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 ↗

Individual participant data

Plan to share: 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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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05532592
Lead sponsor
RenJi Hospital
Responsible party
Yongbing Qian (associate chief physician, RenJi Hospital) — Principal investigator
First posted
Sep 8, 2022
Start date
Apr 27, 2022
Primary completion
May 10, 2022
Completion
May 30, 2022
Last update
Sep 8, 2022

Study contacts

Yongbing Qian, Prof
study director · The department of Liver Surgery, Renji Hospital Shanghai Jiao Tong University.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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