A randomized controlled trial of comparative effectiveness between the 2 dose and 3 dose regimens of hepatitis a vaccine in kidney transplant recipients

Abstract Hepatitis A virus (HAV) is able to cause a spectrum of illnesses ranging from no symptom to fulminant hepatitis which may lead to acute kidney injury. Although hepatitis A vaccine is recommended in non-immune solid organ transplant recipients who live in or travel to endemic areas, the stan...

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Main Authors: Thaninee Prasoppokakorn, Jakapat Vanichanan, Roongruedee Chaiteerakij, Kamonwan Jutivorakool, Suwasin Udomkarnjananun, Krit Pongpirul, Wipusit Taesombat, Salin Wattanatorn, Yingyos Avihingsanon, Kriang Tungsanga, Somchai Eiam-Ong, Kearkiat Praditpornsilpa, Natavudh Townamchai
Format: Article
Language:English
Published: Nature Portfolio 2021-01-01
Series:Scientific Reports
Online Access:https://doi.org/10.1038/s41598-020-80052-3
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author Thaninee Prasoppokakorn
Jakapat Vanichanan
Roongruedee Chaiteerakij
Kamonwan Jutivorakool
Suwasin Udomkarnjananun
Krit Pongpirul
Wipusit Taesombat
Salin Wattanatorn
Yingyos Avihingsanon
Kriang Tungsanga
Somchai Eiam-Ong
Kearkiat Praditpornsilpa
Natavudh Townamchai
author_facet Thaninee Prasoppokakorn
Jakapat Vanichanan
Roongruedee Chaiteerakij
Kamonwan Jutivorakool
Suwasin Udomkarnjananun
Krit Pongpirul
Wipusit Taesombat
Salin Wattanatorn
Yingyos Avihingsanon
Kriang Tungsanga
Somchai Eiam-Ong
Kearkiat Praditpornsilpa
Natavudh Townamchai
author_sort Thaninee Prasoppokakorn
collection DOAJ
description Abstract Hepatitis A virus (HAV) is able to cause a spectrum of illnesses ranging from no symptom to fulminant hepatitis which may lead to acute kidney injury. Although hepatitis A vaccine is recommended in non-immune solid organ transplant recipients who live in or travel to endemic areas, the standard 2-dose vaccination regimen demonstrated less favorable immunogenicity among these population. The 3-dose regimen showed higher response rate and immune durability in patients with human immunodeficiency virus. However, this strategy has never been studied in solid organ transplant recipients. A single-center, open-labeled, computer-based randomized controlled trial (RCT) with a 2:1 allocation ratio was conducted from August 2017 to December 2018. The study compared the seroconversion rate after receiving 2- or 3-dose regimen of hepatitis A vaccine at 0, 6 and 0, 1, 6 months, respectively, in non-immune kidney transplant recipients. A total of 401 adult kidney transplant recipients were screened for anti-HAV IgG and 285 subjects had positive results so the seroprevalence was 71.1%. Of 116 seronegative recipients, 93 (80.2%) completed vaccination; 60 and 33 participants completed 2- and 3-dose vaccination, respectively. The baseline characteristics were comparable between both groups. The seroconversion rate at 1 month after vaccination was 51.7% in the standard 2-dose regimen and 48.5% in the 3-dose regimen (p = 0.769). Overall, the seroconversion rate appeared to be associated with high estimated glomerular infiltration rate, high serum albumin, and low intensity immunosuppressive regimen. Seroconversion rate after hepatitis A vaccination in kidney transplant recipients was less favorable than healthy population. Three-dose regimen did not show superior benefit over the standard 2-dose regimen. Other strategies of immunization may increase immunogenicity among kidney transplant recipients.
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spelling doaj.art-1e8414c5c09a4b999c0e5a4e78a1f6432022-12-21T21:19:45ZengNature PortfolioScientific Reports2045-23222021-01-011111710.1038/s41598-020-80052-3A randomized controlled trial of comparative effectiveness between the 2 dose and 3 dose regimens of hepatitis a vaccine in kidney transplant recipientsThaninee Prasoppokakorn0Jakapat Vanichanan1Roongruedee Chaiteerakij2Kamonwan Jutivorakool3Suwasin Udomkarnjananun4Krit Pongpirul5Wipusit Taesombat6Salin Wattanatorn7Yingyos Avihingsanon8Kriang Tungsanga9Somchai Eiam-Ong10Kearkiat Praditpornsilpa11Natavudh Townamchai12Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial HospitalDivision of Infectious Diseases, Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial HospitalDivision of Gastroenterology, Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial HospitalDivision of Infectious Diseases, Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial HospitalDivision of Nephrology, Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial HospitalDepartment of Preventive and Social Medicine, Faculty of Medicine, Chulalongkorn UniversityExcellence Center for Solid Organ Transplantation, King Chulalongkorn Memorial HospitalDivision of Nephrology, Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial HospitalDivision of Nephrology, Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial HospitalDivision of Nephrology, Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial HospitalDivision of Nephrology, Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial HospitalDivision of Nephrology, Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial HospitalDivision of Nephrology, Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial HospitalAbstract Hepatitis A virus (HAV) is able to cause a spectrum of illnesses ranging from no symptom to fulminant hepatitis which may lead to acute kidney injury. Although hepatitis A vaccine is recommended in non-immune solid organ transplant recipients who live in or travel to endemic areas, the standard 2-dose vaccination regimen demonstrated less favorable immunogenicity among these population. The 3-dose regimen showed higher response rate and immune durability in patients with human immunodeficiency virus. However, this strategy has never been studied in solid organ transplant recipients. A single-center, open-labeled, computer-based randomized controlled trial (RCT) with a 2:1 allocation ratio was conducted from August 2017 to December 2018. The study compared the seroconversion rate after receiving 2- or 3-dose regimen of hepatitis A vaccine at 0, 6 and 0, 1, 6 months, respectively, in non-immune kidney transplant recipients. A total of 401 adult kidney transplant recipients were screened for anti-HAV IgG and 285 subjects had positive results so the seroprevalence was 71.1%. Of 116 seronegative recipients, 93 (80.2%) completed vaccination; 60 and 33 participants completed 2- and 3-dose vaccination, respectively. The baseline characteristics were comparable between both groups. The seroconversion rate at 1 month after vaccination was 51.7% in the standard 2-dose regimen and 48.5% in the 3-dose regimen (p = 0.769). Overall, the seroconversion rate appeared to be associated with high estimated glomerular infiltration rate, high serum albumin, and low intensity immunosuppressive regimen. Seroconversion rate after hepatitis A vaccination in kidney transplant recipients was less favorable than healthy population. Three-dose regimen did not show superior benefit over the standard 2-dose regimen. Other strategies of immunization may increase immunogenicity among kidney transplant recipients.https://doi.org/10.1038/s41598-020-80052-3
spellingShingle Thaninee Prasoppokakorn
Jakapat Vanichanan
Roongruedee Chaiteerakij
Kamonwan Jutivorakool
Suwasin Udomkarnjananun
Krit Pongpirul
Wipusit Taesombat
Salin Wattanatorn
Yingyos Avihingsanon
Kriang Tungsanga
Somchai Eiam-Ong
Kearkiat Praditpornsilpa
Natavudh Townamchai
A randomized controlled trial of comparative effectiveness between the 2 dose and 3 dose regimens of hepatitis a vaccine in kidney transplant recipients
Scientific Reports
title A randomized controlled trial of comparative effectiveness between the 2 dose and 3 dose regimens of hepatitis a vaccine in kidney transplant recipients
title_full A randomized controlled trial of comparative effectiveness between the 2 dose and 3 dose regimens of hepatitis a vaccine in kidney transplant recipients
title_fullStr A randomized controlled trial of comparative effectiveness between the 2 dose and 3 dose regimens of hepatitis a vaccine in kidney transplant recipients
title_full_unstemmed A randomized controlled trial of comparative effectiveness between the 2 dose and 3 dose regimens of hepatitis a vaccine in kidney transplant recipients
title_short A randomized controlled trial of comparative effectiveness between the 2 dose and 3 dose regimens of hepatitis a vaccine in kidney transplant recipients
title_sort randomized controlled trial of comparative effectiveness between the 2 dose and 3 dose regimens of hepatitis a vaccine in kidney transplant recipients
url https://doi.org/10.1038/s41598-020-80052-3
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