Safety and efficacy of a recombinant yeast-derived pre-S2 + S-containing hepatitis B vaccine (TGP-943): phase 1, 2 and 3 clinical testing.
A recombinant yeast-derived pre-S2 + S-containing hepatitis B vaccine (TGP-943) was clinically evaluated through three phases of testing in a total of 2137 volunteers. We observed the immunogenic purity of TGP-943 (phase 1), the inter-lot reproducibility of both safety and immunogenicity (phase 2), no significant side-effects, a high capability of inducing both anti-HBs and anti-pre-S2 antibodies (phases 1, 2 and 3), and an ability to induce seroconversion in the majority of vaccines who had been non-responsive to conventional hepatitis B vaccines (phases 2 and 3). In conclusion, TGP-943 is a safe and tolerable vaccine, with special merits: the ability to induce an early anti-pre-S2 response that circumvents the problem of delayed appearance of anti-HBs, and efficacy in non-responders to previous vaccination.
Suzuki
H
H
First Department of Internal Medicine, Yamanashi Medical College, Japan.
Iino
S
S
Shiraki
K
K
Akahane
Y
Y
Okamoto
H
H
Domoto
K
K
Mishiro
S
S
D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000595:Amino Acid Sequence; D002648:Child; D005260:Female; D006510:Hepatitis B Antibodies / Q000096:biosynthesis; D006514:Hepatitis B Surface Antigens / Q000276:immunology*; D017325:Hepatitis B Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D006801:Humans; D007273:Injections, Intramuscular; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D008969:Molecular Sequence Data; D011498:Protein Precursors / Q000276:immunology*; D011863:Radioimmunoassay; D015203:Reproducibility of Results; D012449:Safety; D014614:Vaccines, Synthetic / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D011498:Protein Precursors; C069095:TGP 943 vaccine; D014614:Vaccines, Synthetic