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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Nature Portfolio
2021
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oai:doaj.org-article:1e8414c5c09a4b999c0e5a4e78a1f6432021-12-02T15:08:27ZA randomized controlled trial of comparative effectiveness between the 2 dose and 3 dose regimens of hepatitis a vaccine in kidney transplant recipients10.1038/s41598-020-80052-32045-2322https://doaj.org/article/1e8414c5c09a4b999c0e5a4e78a1f6432021-01-01T00:00:00Zhttps://doi.org/10.1038/s41598-020-80052-3https://doaj.org/toc/2045-2322Abstract 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.Thaninee PrasoppokakornJakapat VanichananRoongruedee ChaiteerakijKamonwan JutivorakoolSuwasin UdomkarnjananunKrit PongpirulWipusit TaesombatSalin WattanatornYingyos AvihingsanonKriang TungsangaSomchai Eiam-OngKearkiat PraditpornsilpaNatavudh TownamchaiNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-7 (2021) |
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Medicine R Science Q 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 |
| 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. |
| format |
article |
| 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 |
| 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_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_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_sort |
randomized controlled trial of comparative effectiveness between the 2 dose and 3 dose regimens of hepatitis a vaccine in kidney transplant recipients |
| publisher |
Nature Portfolio |
| publishDate |
2021 |
| url |
https://doaj.org/article/1e8414c5c09a4b999c0e5a4e78a1f643 |
| work_keys_str_mv |
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