A Pilot Study of Therapeutic Vaccination With Envelope Protein E1 in 35 Patients With Chronic Hepatitis C

• DOI: 10.1053/jhep.2003.50474
• Publication Date: 2003-10-23T14:25:20Z
• Authors: Frederik Nevens; Tania Roskams; Hans Van Vlierberghe; Yves Horsmans; Dirk Sprengers; Ann Elewaut; Valeer Desmet; Geert Leroux-Roels; Emmanuel Quinaux; Erik Depla; Stephanie Dincq; Christine Vander ...; Geert Maertens; Frank Hulstaert
• Keywords: Male; Viral Structural Proteins; 0301 basic medicine; Alanine Transaminase; Pilot Projects; Hepacivirus; Hepatitis C, Chronic; Middle Aged; Fibrosis; 3. Good health; 03 medical and health sciences; Antibody Formation; Humans; RNA, Viral; Female

New treatments are needed for chronic hepatitis C patients in whom viral clearance cannot be achieved. Thirty–five (genotype 1) were randomized to receive 20 μg of recombinant HCV E1 (E1) (n = 26) or placebo 9) intramuscularly at weeks 0, 4, 8, 12, and 24. Thirty–four then received open–label vaccine 50, 53, 56, 59, 62, 65. Twenty–four (12 men, 12 women; mean age, 52 y; 18 interferon–based treatment failures; baseline alanine aminotransferase [ALT] level, 118 IU/L) underwent a biopsy before after 2 courses E1, 17 months later. Liver histology was scored by blinded pathologists according the Ishak Metavir systems. Postinjection reactions similar (alum only). Nine 24 (38%) had improvement points more, 10 (41%) remained stable, 5 (21%) showed worsening total score. improved both on fibrosis scores. Plasma HCV–RNA levels unchanged, whereas ALT trend toward decrease during treatment. All but 3 developed significant de novo E1–specific T–cell response. The increase anti–E1 antibody correlated with score relative decreases level (all P ≤ .01). In conclusion, therapeutic vaccination is well tolerated observed effects warrant further study.