A candidate vaccine based on the hepatitis C E1 protein: tolerability and immunogenicity in healthy volunteers.
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.
Leroux-Roels
Geert
G
Center for Vaccinology, Ghent University and Hospital, De Pintelaan 185, B-9000 Ghent, Belgium.
Depla
Erik
E
Hulstaert
Frank
F
Tobback
Leen
L
Dincq
Stéphanie
S
Desmet
Jaques
J
Desombere
Isabelle
I
Maertens
Geert
G
D000293:Adolescent; D000328:Adult; D000917:Antibody Formation / Q000276:immunology; D006526:Hepatitis C / Q000276:immunology* / Q000517:prevention & control*; D018937:Hepatitis C Antibodies / Q000032:analysis / Q000096:biosynthesis; D006801:Humans; D007111:Immunity, Cellular / Q000276:immunology; D007117:Immunization, Secondary; D007273:Injections, Intramuscular; D007371:Interferon-gamma / Q000032:analysis / Q000096:biosynthesis; D015848:Interleukin-5 / Q000032:analysis / Q000096:biosynthesis; D018655:Lymphocyte Count; D008297:Male; D008875:Middle Aged; D013601:T-Lymphocytes / Q000276:immunology; D014614:Vaccines, Synthetic / Q000276:immunology; D014759:Viral Envelope Proteins / Q000009:adverse effects / Q000276:immunology*; D014765:Viral Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*
C087035:E1 protein, Hepatitis C virus; D018937:Hepatitis C Antibodies; D015848:Interleukin-5; D014614:Vaccines, Synthetic; D014759:Viral Envelope Proteins; D014765:Viral Vaccines; D007371:Interferon-gamma