Chiron Corp HCV E1/E2 Vaccine

Summary

The purposes of this study are to evaluate the safety, tolerability, and effectiveness of a vaccine (the HCV E1/E2/MF59 vaccine) against hepatitis C (HCV). The vaccine will be given to 60 healthy adult volunteers (aged 18-45 years) and the study will compare the immune system (the body's protective response) response to the HCV E1/E2 vaccine given at different dosage levels: 4 micrograms, 20 micrograms, or 100 micrograms in MF59 adjuvant (substance that can improve vaccine effectiveness). The volunteers will be assigned randomly (by chance) to 1 of 4 different groups. Volunteers in each group will receive a shot of the vaccine or a placebo (shot with no medication). Participants will be involved in study related procedures for up to 71 weeks, which includes blood samples, recording symptoms on a diary card, and 4 vaccine or placebo injections.

Timeline

Start

2003-08

Primary completion

2005-08

Completion

2005-08

Publications

• Nguyen YTK, Chen F, Giang E, Saha S, Ueno LA, Chen C, Watson CT, Tzarum N, Wilson IA, Law M, Stanfield RL. Structural and genetic signatures of two classes of HCV E2 neutralizing face antibodies from non-human primates immunized with a recombinant E1E2. NPJ Vaccines. 2026 Apr 21. doi: 10.1038/s41541-026-01449-1. Online ahead of print.
• Nguyen YTK, Chen F, Giang E, Saha S, Ueno LA, Chen C, Watson CT, Tzarum N, Wilson IA, Law M, Stanfield R. Structural and genetic signatures of two classes of HCV E2 neutralizing face antibodies from non-human primates immunized with a recombinant E1E2. bioRxiv [Preprint]. 2025 Oct 7:2025.10.07.680784. doi: 10.1101/2025.10.07.680784.
• Chen F, Nagy K, Chavez D, Willis S, McBride R, Giang E, Honda A, Bukh J, Ordoukhanian P, Zhu J, Frey S, Lanford R, Law M. Antibody Responses to Immunization With HCV Envelope Glycoproteins as a Baseline for B-Cell-Based Vaccine Development. Gastroenterology. 2020 Mar;158(4):1058-1071.e6. doi: 10.1053/j.gastro.2019.11.282. Epub 2019 Dec 4.
• Kachko A, Frey SE, Sirota L, Ray R, Wells F, Zubkova I, Zhang P, Major ME. Antibodies to an interfering epitope in hepatitis C virus E2 can mask vaccine-induced neutralizing activity. Hepatology. 2015 Dec;62(6):1670-82. doi: 10.1002/hep.28108. Epub 2015 Oct 16.
• Frey SE, Houghton M, Coates S, Abrignani S, Chien D, Rosa D, Pileri P, Ray R, Di Bisceglie AM, Rinella P, Hill H, Wolff MC, Schultze V, Han JH, Scharschmidt B, Belshe RB. Safety and immunogenicity of HCV E1E2 vaccine adjuvanted with MF59 administered to healthy adults. Vaccine. 2010 Aug 31;28(38):6367-73. doi: 10.1016/j.vaccine.2010.06.084. Epub 2010 Jul 7.

Drugs

Indications