Post-vaccination hepatitis B seroprotection among kidney transplant recipients in Saudi Arabia: a retrospective cohort study
DOI:
https://doi.org/10.18203/2320-6012.ijrms20262796Keywords:
Hepatitis B vaccination, Seroprotection, Kidney transplantation, Anti-HBs antibodies, Vaccine nonresponseAbstract
Background: Evidence regarding post-vaccination hepatitis B virus (HBV) seroprotection among kidney transplant recipients in Saudi Arabia remains limited. This study estimated the prevalence of seroprotection and evaluated factors associated with vaccine nonresponse.
Methods: This single-center retrospective cohort study included adult kidney transplant recipients followed at Prince Sultan Military Medical City, Riyadh, Saudi Arabia, who had documented hepatitis B vaccination and subsequent quantitative measurement of antibodies to hepatitis B surface antigen (anti-HBs). Seroprotection was defined as an anti-HBs concentration of at least 10 mIU/ml. Participant characteristics were compared according to seroprotection status. Multivariable logistic regression was used to evaluate associations between non-seroprotection and total number of hepatitis B vaccine doses.
Results: Among 100 kidney transplant recipients, the mean (SD) age was 41.4 (15.2) years, and 66 participants (66.0%) were male. Overall, 69 recipients achieved seroprotection (69.0%; 95% CI, 59.4-77.2%), whereas 31 (31.0%) remained non-seroprotected. Vaccine dose category differed significantly by seroprotection status (p=0.014); 80.6% of non-seroprotected recipients had received only 1 to 2 doses compared with 50.7% of seroprotected recipients. In the adjusted model, no variable was independently associated with non-seroprotection. Each 10-year increase in age was associated with higher, but not statistically significant, odds of non-seroprotection (aOR, 1.44; 95% CI, 0.96-2.16; p=0.079).
Conclusions: Nearly one-third of vaccinated kidney transplant recipients lacked serological protection against HBV. Routine post-vaccination anti-HBs testing and individualized booster or revaccination strategies should be considered, particularly for older recipients and those who have received fewer vaccine doses.
References
World Health Organization. Global hepatitis report 2024: action for access in low- and middle-income countries. 2024. Available at: https://www.who.int/publications/i/item/9789240091672. Accessed on 15 May 2026.
Alghamdi IG, Alghamdi RM, Alghamdi MS, Alghamdi AM, Alghamdi MI, Alghamdi ZI, et al. Epidemiology of hepatitis B in Saudi Arabia from 2006 to 2021. Hepat Med. 2023;15:233-47.
Abdo AA, Sanai FM, Al-Faleh FZ. Epidemiology of viral hepatitis in Saudi Arabia: are we off the hook? Saudi J Gastroenterol. 2012;18:349-57.
Chancharoenthana W, Traitanon O, Leelahavanichkul A, Ronco C. Optimizing hepatitis B vaccination in chronic kidney disease: a comprehensive scoping review of strategies across CKD stages, dialysis, and transplant populations. Ren Fail. 2025;47:2541873.
Kidney Disease: Improving Global Outcomes Transplant Work Group. KDIGO clinical practice guideline for the care of kidney transplant recipients. Am J Transplant 2009;9(3):S1-155.
Dadhania DM, Cravedi P, Blumberg E, Stryniak G, Montez-Rath ME, Maltzman JS. Age-related decline in anti-HBV antibodies in vaccinated kidney transplant recipients. Transpl Infect Dis. 2023;25:e14090.
Yin S, Zhang F, Wu J, Lin T, Wang X. Incidence, risk factors, and clinical outcomes of HBV reactivation in non-liver solid organ transplant recipients with resolved HBV infection: a systematic review and meta-analysis. PLoS Med. 2023;20:e1004196.
Chen J, Wu B, Chen J, Chu Q. Incidence and risk factors for hepatitis B virus reactivation in kidney transplant recipients: a systematic review and meta-analysis. BMC Nephrol. 2026;27:325.
Schillie S, Vellozzi C, Reingold A, Harris AM, Haber P, Ward JW, et al. Prevention of hepatitis B virus infection in the United States: recommendations of the Advisory Committee on Immunization Practices. MMWR Recomm Rep. 2018;67:1-31.
World Health Organization. Consolidated guidelines on hepatitis B and C prevention, testing, treatment, service delivery and monitoring: an implementation handbook for a public health approach. 2026. Available at: https://www.who.int/publications/i/item/9789240119529. Accessed on 15 May 2026.
Al Saran K, Sabry A, Al Halawany Z, Ismail M. Factors affecting response to hepatitis B vaccine among hemodialysis patients in a large Saudi hemodialysis center. Saudi J Kidney Dis Transpl. 2014;25:185-91.
von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP, et al. The Strengthening the Reporting of Observational Studies in Epidemiology statement: guidelines for reporting observational studies. Lancet. 2007;370:1453-7.
Benchimol EI, Smeeth L, Guttmann A, Harron K, Moher D, Petersen I, et al. The REporting of studies Conducted using Observational Routinely-collected health Data statement. PLoS Med. 2015;12:e1001885.
Lau G, Yu ML, Wong G, Thompson A, Ghazinian H, Hou JL, et al. APASL clinical practice guideline on hepatitis B reactivation related to the use of immunosuppressive therapy. Hepatol Int. 2021;15:1031-48.
Weng MK, Doshani M, Khan MA, Frey S, Ault K, Moore KL, et al. Universal hepatitis B vaccination in adults aged 19-59 years: updated recommendations of the Advisory Committee on Immunization Practices—United States, 2022. MMWR Morb Mortal Wkly Rep. 2022;71:477-83.
Conners EE, Panagiotakopoulos L, Hofmeister MG, Spradling PR, Hagan LM, Harris AM, et al. Screening and testing for hepatitis B virus infection: CDC recommendations—United States, 2023. MMWR Recomm Rep. 2023;72:1-25.
Altman DG, Royston P. The cost of dichotomising continuous variables. BMJ. 2006;332:1080.
Firth D. Bias reduction of maximum likelihood estimates. Biometrika. 1993;80:27-38.
Heinze G, Schemper M. A solution to the problem of separation in logistic regression. Stat Med. 2002;21:2409-19.
Brown LD, Cai TT, DasGupta A. Interval estimation for a binomial proportion. Stat Sci. 2001;16:101-33.
Harrell FE Jr. Regression modeling strategies: with applications to linear models, logistic regression, and survival analysis. New York, NY: Springer; 2001.
Christodoulou E, Ma J, Collins GS, Steyerberg EW, Verbakel JY, Van Calster B. A systematic review shows no performance benefit of machine learning over logistic regression for clinical prediction models. J Clin Epidemiol. 2019;110:12-22.
Jain SR, Kumar D. Vaccination for the post-kidney transplant population. Curr Opin Nephrol Hypertens. 2019;28:581-6.
Chiu CY, Sampathkumar P, Brumble LM, Vikram HR, Watt KD, Beam E. Optimizing hepatitis B virus seroprotection in thoracic organ transplantation: the role of the HepB-CpG vaccination schedule. Vaccine. 2025;47:126705.
Chiu CY, Sampathkumar P, Brumble LM, Vikram HR, Watt KD, Beam E. Hepatitis B vaccine compliance, serologic response, and durability in adult thoracic organ transplant recipients. Clin Transplant. 2024;38:e15464.
Velikova T, Gerasoudis S, Batselova H. Vaccination for solid organ transplanted patients: recommendations, efficacy, and safety. World J Transplant. 2024;14:92172.
Waller KMJ, De La Mata N, Hedley JA, Sharma T, Davies R, Garrett E, et al. Transmission risk of intentional transplantation of kidneys from donors with active hepatitis B to recipients without active hepatitis B: a systematic review and meta-analysis. Transplantation. 2026;110:e912-22.
Iwata K, Ikegaki S, Hyodo Y, Miyake H. Hepatitis B boosters using a different product versus the same product for kidney transplant recipients: a retrospective study with Bayesian inference. Clin Transplant. 2025;39:e70307.
Chancharoenthana W, Leelahavanichkul A, Udomkarnjananun S, Wattanatorn S, Avihingsanon Y, Praditpornsilpa K, et al. Durability of antibody response against the hepatitis B virus in kidney transplant recipients: a proposed immunization guideline from a 3-year follow-up clinical study. Open Forum Infect Dis. 2019;6:ofy342.
Yin S, Chen X, Li X, Zhang F, Wu J, Lin T. Was antiviral prophylaxis necessary after kidney transplantation utilizing anti-HBc-positive donors? A systematic review and meta-analysis. Transplant Rev (Orlando). 2024;38:100840.
Paschereit A, Greese V, Sakurayama K, Duerr M, Halleck F, Liefeldt L, et al. Impact of hepatitis B infection on patient and graft survival after kidney transplantation. J Clin Med. 2025;14:2124.