SAFETY AND EFFICACY OF A RECOMBINANT YEAST-DERIVED PRE-S2 PLUS S-CONTAINING HEPATITIS-B VACCINE (TGP-943) - PHASE-1, PHASE-2 AND PHASE-3 CLINICAL-TESTING

被引：30

作者：

SUZUKI, H

IINO, S

SHIRAKI, K

AKAHANE, Y

OKAMOTO, H

DOMOTO, K

MISHIRO, S

机构：

[1] INST IMMUNOL,BUNKYO KU,TOKYO 112,JAPAN

[2] YAMANASHI MED COLL,DEPT INTERNAL MED 1,TAMAHO,YAMANASHI 40938,JAPAN

[3] ST MARIANNA UNIV,SCH MED,CTR REFRACTORY DIS,KAWASAKI,KANAGAWA 216,JAPAN

[4] TOTTORI UNIV,SCH MED,DEPT PEDIAT,YONAGO,TOTTORI 683,JAPAN

[5] JICHI MED SCH,DIV IMMUNOL,MINAMI KAWACHI,TOCHIGI 32904,JAPAN

[6] TAKEDA CHEM IND,DIV PHARMACEUT DEV,CHUO KU,TOKYO 103,JAPAN

来源：

VACCINE | 1994年 / 12卷 / 12期

关键词：

HEPATITIS B VACCINE; PRE-S2; PROTEIN; TGP-943; ANTI-PRE-S2; ANTIBODY; ANTI-HBS ANTIBODY; NONRESPONDERS;

D O I：

10.1016/0264-410X(94)90178-3

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

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 vaccinees 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.

引用

页码：1090 / 1096

页数：7

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