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  • Three double-dose reinforced hepatitis B revaccination scheme for patients with cirrhosis unresponsive to the standard regimen: an open-label randomised clinical trial

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Hepatology
Original research
Three double-dose reinforced hepatitis B revaccination scheme for patients with cirrhosis unresponsive to the standard regimen: an open-label randomised clinical trial
  1. Álvaro Giráldez-Gallego1,2,
  2. Elisa del Pilar Rodríguez-Seguel2,3,4,
  3. Raquel Valencia-Martín5,6,
  4. Áurea Morillo-García5,6,
  5. Celia Salamanca-Rivera5,6,
  6. Ricardo Ruiz-Pérez2,3,
  7. María Cuaresma-Duque2,3,
  8. Clara Rosso-Fernández7,
  9. María Teresa Ferrer-Ríos1,2,
  10. José Manuel Sousa-Martín1,2,
  11. Juan Manuel Praena-Fernández8,9,
  12. Trinidad Desongles-Corrales10,
  13. Aitana Rodríguez-Pérez10,
  14. Francisco Camino-Durán5,
  15. Antonia Gasch-Illescas5,6,11,12,
  16. Javier Ampuero-Herrojo1,2,13,14,
  17. Juan Manuel Pascasio-Acevedo1,2
  1. 1 Unit for the Clinical Management of Digestive Diseases, Virgen del Rocío University Hospital, Seville, Andalusia, Spain
  2. 2 Liver Diseases, Instituto de Biomedicina de Sevilla, IBiS/Hospital Universitario Virgen del Rocío/CSIC/Universidad de Sevilla, Seville, Andalusia, Spain
  3. 3 Digestive Diseases Research Unit, Virgen Del Rocío University Hospital, Seville, Andalusia, Spain
  4. 4 Cell Biology Department, Faculty of Biology, University of Seville, Seville, Andalusia, Spain
  5. 5 Preventive Medicine and Public Health Department, Virgen del Rocío University Hospital, Seville, Andalusia, Spain
  6. 6 Department of Preventive Medicine and Public Health, Faculty of Medicine. University of Seville, Seville, Andalusia, Spain
  7. 7 Clinical Trial Unit, Virgen del Rocío University Hospital, Seville, Andalusia, Spain
  8. 8 Statistics, Methodology and Evaluation for Clinical Investigation, Instituto de Biomedicina de Sevilla, IBiS/Hospital Universitario Virgen del Rocío/CSIC/Universidad de Sevilla, Seville, Andalusia, Spain
  9. 9 Department of Nursery, Faculty of Nursing, Physiotherapy and Podiatry. University of Seville, Seville, Andalusia, Spain
  10. 10 Pharmacy Unit, Virgen del Rocío University Hospital, Seville, Andalusia, Spain
  11. 11 Prevention in Health and Longevity Centre, Institut Pasteur de Lille, Lille, Hauts de France, France
  12. 12 Infectious and Immune System Diseases-Epidemiology and Public Health, Instituto de Biomedicina de Sevilla, IBiS/Hospital Universitario Virgen del Rocío/CSIC/Universidad de Sevilla, Seville, Andalusia, Spain
  13. 13 Department of Medicine, Faculty of Medicine. University of Seville, Seville, Andalusia, Spain
  14. 14 Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Seville, Andalusia, Spain
  1. Correspondence to Dr Álvaro Giráldez-Gallego, Hepatology, Virgen del Rocio University Hospital, Sevilla 41013, Spain; giraldezg{at}hotmail.com

Abstract

Objective We aimed to compare the response rates between two different hepatitis B virus vaccination schedules for cirrhotic subjects who were non-responders to the first three 40 µg doses (month 0-1-2), and identify factors associated with the final response.

Design A total of 120 cirrhotic patients (72.5% decompensated) were randomised at a 1:1 ratio to receive a single 40 µg booster vaccination at month 6 (classical arm) versus an additional round of three new 40 µg doses administered at monthly intervals (experimental arm). The main outcome was the rate of postvaccinal anti-hepatitis B surface antibodies levels ≥10 mIU/mL.

Results Efficacy by ITT analysis was higher in the experimental arm (46.7%) than in the classical one (25%); OR 2.63, p=0.013. The experimental arm increased response rates compared with the classical one from 31% to 68% (OR 4.72; p=0.007), from 24.4% to 50% (OR 3.09; p=0.012) and from 24.4% to 53.8% (OR 3.62; p=0.007), in Child A, Model for End-Stage Liver Disease (MELD) <15 and MELD-Na<15 patients, respectively. Patients with more advanced liver disease did not benefit from the reinforced scheme. Both regimens showed similar safety profiles. Multivariable analysis showed that the experimental treatment was independently response associated when adjusted across three logistic regression models indicating equivalent cirrhosis severity.

Conclusion For cirrhotic patients, the revaccination of non-responders to the first three dose cycle, with three additional 40 µg doses, achieved significantly better response rates to those obtained with an isolated 40 µg booster dose.

Trial registration number NCT01884415.

  • CIRRHOSIS
  • LIVER TRANSPLANTATION
  • HEPATITIS B

Data availability statement

Data are available on reasonable request.

https://doi.org/10.1136/gutjnl-2022-328222

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    Data availability statement

    Data are available on reasonable request.

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    Footnotes

    • ÁG-G, EdPR-S and JMP-A are joint first authors.

    • ÁG-G, EdPR-S and JMP-A are joint senior authors.

    • Twitter @CRosso

    • ÁG-G, EdPR-S and JMP-A contributed equally.

    • Correction notice This article has been corrected since it published Online First. The headings in table 3 have been amended and affiliations updated.

    • Contributors ÁG-G, EdPR-S and JMP: study concept and design, data acquisition, data analysis and interpretation, manuscript preparation, critical manuscript revision for important intellectual content, statistical analysis, obtained funding, provided technical and/or material support and study supervision. ÁG-G is also the guarantor, responsible for the overall content and accepts full responsibility for the work and the conduct of the study. RV-M, ÁM-G and CS-R: data acquisition, analysis and data interpretation, manuscript preparation, critical manuscript revision for important intellectual content, obtained funding, provided technical and/or material support and study supervision. RR-P, MC-D and CR-F: study concept and design, data acquisition, critical manuscript revision for important intellectual content, statistical analysis and obtained funding, provided technical and/or material support. MTF-R, JMS and JA: data acquisition, analysis and interpretation of data, manuscript preparation, critical manuscript revision for important intellectual content and study supervision. JMP-F: data analysis and interpretation, manuscript preparation, critical manuscript revision for important intellectual content and statistical analysis. TD-C and AR-P: manuscript preparation, critical manuscript revision for important intellectual content, obtained funding, provided technical and/or material support. FC-D and AG-I: data acquisition, critical manuscript revision for important intellectual content, obtained funding, provided technical and/or material support. All the authors read and approved the final version of the paper.

    • Funding This study project was awarded competitive public funding for Independent Research from the Spanish Government Ministry of Health and Social Politics in 2011 via the Carlos III Health Institute (EC11-452). Javier Ampuero is supported by grants from the Carlos III Health Institute (GLD19/00100 and PI19/01404). IBiS was created as a partnership between the Junta of Andalusia Department of Health, the Department of Innovation, Science and Business of the Junta of Andalusia, the Andalusian Health Service, the University of Seville and the Spanish National Research Council.

    • Disclaimer These funding bodies had no influence on study design, data collection and analysis, the decision to publish or manuscript preparation.

    • Competing interests ÁG-G has received speaker fees from Gilead, Gore, MSD, BMS and Abbvie. MTF-R has received speaker fees from Bayer, Gilead, Abbvie and MSD. JMS-M has received lecture fees from Gilead, Abbvie and Intercept. JA has received speaker fees from Abbvie and Gilead, is an Advisory Board member of Intercept, GMP-Orphan and Novo Nordisk, and is supported by grants from Gilead. JMP-A has received lecture fees from Gilead, Abbvie and Astellas, and is supported by grants from Gilead. For all authors, both fees and grants were unrelated to the submitted work.

    • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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