A candidate vaccine based on the hepatitis C E1 protein: tolerability and immunogenicity in healthy volunteers

• DOI: 10.1016/j.vaccine.2004.02.002
• Publication Date: 2004-02-24T05:16:02Z
• Authors: Geert Leroux-Roels; Erik Depla; Frank Hulstaert; Leen Tobback; Stéphanie Dincq; Jaques Desmet; Isabelle Desombere; Geert Maertens
• Keywords: Adult; Male; 0301 basic medicine; Immunity, Cellular; Vaccines, Synthetic; Adolescent; T-Lymphocytes; Immunization, Secondary; Viral Vaccines; Hepatitis C Antibodies; Middle Aged; Hepatitis C; Injections, Intramuscular; 3. Good health; Interferon-gamma; 03 medical and health sciences; Viral Envelope Proteins; Antibody Formation; Humans; Lymphocyte Count; Interleukin-5

The tolerability and immunogenicity of the hepatitis C virus E1 protein as a candidate vaccine was examined in a Phase I, single-arm study. Twenty healthy male volunteers were injected in the deltoid muscle at weeks 0, 3 and 6 with 20 microg recombinant E1 adsorbed on alum. A fourth (booster) dose was administered to 19 subjects at week 26. The candidate therapeutic vaccine was well tolerated. Three vaccine doses induced a clear humoral anti-E1 response that was boosted by a fourth dose. A strong, specific cellular immune response towards E1 was elicited in all vaccine recipients, which included a clear Th1 type response in all but one of the subjects.