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

NCT05532592 | Completed DMC

• 1 other identifier: KY2022-138-B
• Study Type: observational
• Target: 449
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vaccine Hesitancy

Keywords

COVID-19; vaccine; vaccine hesitancy; liver transplant recipients; China

Outcome Measures

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.

  through study completion, an average of 1 year

Study Arms (2)

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

Perceptions and attitudes towards COVID-19 and COVID-19 vaccine OTHER

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

hesitancy group (HG); no hesitancy group (NHG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• age ≥ 18
• recipients after liver transplantation surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

The department of Liver Surgery, Renji Hospital Shanghai Jiao Tong University.

Shanghai, Shanghai Municipality, 200127, China

Location

Related 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.

  PMID: 33148977 BACKGROUND

• 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.

  PMID: 29381581 BACKGROUND

• 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.

  PMID: 33941488 BACKGROUND

• 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.

  PMID: 33563499 BACKGROUND

• 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.

  PMID: 33577086 BACKGROUND

• 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.

  PMID: 30997357 BACKGROUND

• 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.

  PMID: 25896383 BACKGROUND

• 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.

  PMID: 34586945 BACKGROUND

• 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.

  PMID: 34835245 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Vaccination Hesitancy; COVID-19

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Vaccination Refusal; Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Yongbing Qian, Prof

  The department of Liver Surgery, Renji Hospital Shanghai Jiao Tong University.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: September 5, 2022
• First Posted: September 8, 2022
• Study Start: April 27, 2022
• Primary Completion: May 10, 2022
• Study Completion: May 30, 2022
• Last Updated: September 8, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)