HCV E1E2-MF59 vaccine in chronic hepatitis C patients treated with PEG-IFNα2a and Ribavirin: A randomized controlled trial

P. Colombatto, M. R. Brunetto, A. M. Maina, V. Romagnoli, P. Almasio, M. G. Rumi, A. Ascione, G. Pinzello, M. Mondelli, L. Muratori, R. Rappuoli, D. Rosa, M. Houghton, S. Abrignani, F. Bonino

Research output: Contribution to journalArticle

Abstract

Summary Hepatitis C virus (HCV) vaccines may be able to increase viral clearance in combination with antiviral therapy. We analysed viral dynamics and HCV-specific immune response during retreatment for experienced patients in a phase Ib study with E1E2MF59 vaccine. Seventy-eight genotype 1a/1b patients [relapsers (30), partial responders (16) and nonresponders (32) to interferon-(IFN)/ribavirin-(RBV)] were randomly assigned to vaccine (V:23), Peg-IFNα2a-180-ug/qw and ribavirin 1000-1200-mg/qd for 48 weeks (P/R:25), or their combination (P/R + V:30). Vaccine (100 μg/0.5 mL) was administered intramuscularly at week 0-4-8-12-24-28-32-36. Neutralizing of binding (NOB) antibodies and lymphocyte proliferation assay (LPA) for E1E2-specific-CD4 + T cells were performed at week 0-12-16-48. Viral kinetics were analysed up to week 16. The vaccine was safe, and a sustained virological response (SVR) was achieved in 4 P/R + V and 2 P/R patients. Higher SVR rates were observed in prior relapsers (P/R + V = 27.3%; P/R = 12.5%). Higher NOB titres and LPA indexes were found at week 12 and 16 in P/R + V as compared to P/R patients (P = 0.023 and 0.025, P = 0.019 and

Original languageEnglish
Pages (from-to)458-465
Number of pages8
JournalJournal of Viral Hepatitis
Volume21
Issue number7
DOIs
Publication statusPublished - 2014

Keywords

  • HCV
  • immune response
  • interferon
  • neutralizing antibodies
  • vaccine
  • viral kinetics

ASJC Scopus subject areas

  • Hepatology
  • Infectious Diseases
  • Virology
  • Medicine(all)

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    Colombatto, P., Brunetto, M. R., Maina, A. M., Romagnoli, V., Almasio, P., Rumi, M. G., Ascione, A., Pinzello, G., Mondelli, M., Muratori, L., Rappuoli, R., Rosa, D., Houghton, M., Abrignani, S., & Bonino, F. (2014). HCV E1E2-MF59 vaccine in chronic hepatitis C patients treated with PEG-IFNα2a and Ribavirin: A randomized controlled trial. Journal of Viral Hepatitis, 21(7), 458-465. https://doi.org/10.1111/jvh.12163