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

Vaccine Hesitancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05532592
• Other study ID #: KY2022-138-B
• Status: Completed
• Start date: April 27, 2022
• Est. completion date: May 30, 2022

Study information

• Verified date: September 2022
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 449
• Est. completion date: May 30, 2022
• Est. primary completion date: May 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. age = 18

2. recipients after liver transplantation surgery

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

Related Conditions & MeSH terms

• COVID-19
• Vaccine Hesitancy

Intervention

Other:
• Perceptions and attitudes towards COVID-19 and COVID-19 vaccine
Attitude towards COVID-19; Knowledge about COVID-19 vaccine

Locations

Country	Name	City	State
China	The department of Liver Surgery, Renji Hospital Shanghai Jiao Tong University.	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

References & Publications (9)

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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). pii: 1314. doi: 10.3390/vaccines9111314. — View Citation

Facciolà 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through study completion, an average of 1 year

External Links

•   World Health Organization (WHO). Draft landscape of COVID-19 candidate vaccines. 2021 June 15.