Suzuki H, Iino S, Shiraki K, Akahane Y, Okamoto H, Domoto K, Mishiro S
First Department of Internal Medicine, Yamanashi Medical College, Japan.
Vaccine. 1994 Sep;12(12):1090-6. doi: 10.1016/0264-410x(94)90178-3.
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.
一种重组酵母衍生的含前S2+S的乙型肝炎疫苗（TGP-943）在总共2137名志愿者中进行了三个阶段的临床评估。我们观察到了TGP-943的免疫原性纯度（1期）、批次间安全性和免疫原性的可重复性（2期）、无明显副作用、诱导抗-HBs和抗前S2抗体的高能力（1期、2期和3期），以及在大多数对传统乙型肝炎疫苗无反应的接种者中诱导血清转化的能力（2期和3期）。总之，TGP-943是一种安全且耐受性良好的疫苗，具有特殊优点：能够诱导早期抗前S2反应，从而规避抗-HBs出现延迟的问题，以及对先前接种无反应者有效。
