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HEPATITIS B VACCINE

Foreign code F190009745
File No. S2017-0862-C0
Posted date May 7, 2019
Country WIPO
International application number 2018JP027412
International publication number WO 2019013361
Date of international filing Jul 13, 2018
Date of international publication Jan 17, 2019
Priority data
  • P2017-138047 (Jul 14, 2017) JP
Title HEPATITIS B VACCINE
Abstract This hepatitis B vaccine includes surface antigen particles formed in which only L-proteins of the hepatitis B virus, or mutants of said L-proteins, collect on the lipid membrane.
Outline of related art and contending technology BACKGROUND ART
(HBV) hepatitis B virus surface antigen is, L antigen (Pre-S1, Pre-S2 and S formed from a region), the antigen M (Pre-S2 and S formed from a region) and the antigen S (S is formed only from) there are two types of 3 (each of these antigens, antigen HBs-L, an antigen HBs-M, also referred to as antigen HBs-S.). Hepatitis B vaccine is, the antigen S are mainly used, in part, M antigens have been used. HBV surface antigens of the protein that functions as, Pre-S1 region recognizes human hepatocytes HBV virus, is coupled to the sensor. Therefore, the function of the Pre-S1 region against Hepatitis B vaccine is neutralizing antibodies as well as promising, HBV spread of the virus body to prevent important as a vaccine treatment means.
L a gene encoding a protein (referred to as L antigen gene) is, a single translation start site and 3 have a common termination codon. Therefore L CHO cell antigen gene is expressed in a cell of the animal, L, M and S of the two proteins 3 are formed. The 3 one protein in the lipid particles can be presented to one of L, M and S protein antigen is mixed with the particles will be formed. Under such circumstances, one of the 3 antigen is an antigen L, M and S using a mixture of an antigen and antigen vaccine has been known (for example, a prophylactic vaccine is commercially available (VBI Vaccines inc. Israel) Sci-B-VacTM. In addition, a mixture of 3 types of treatment of hepatitis B antigen used as a vaccine may be considered to be (HBV vaccine and a manufacturing method thereof: JP-2010-516807). However, these L of the antigen is an antigen, antigen and antigen S M is a mixture of, by using L antigen vaccine development is not known.
However, the duration (HBV) hepatitis B viral infection in the world the user is expected to exist about 4 million and, in japan HBV infection rates up to 1.5%. In japan, HBV mother infant for contamination prevention, screening of blood transfusion, administration of the vaccine to the high risk group (selective vaccination) has the effect of various precautions such as successful, the user tends to decrease the number of HBV infection. On the other hand, these precautions are not subject to many people, not against HBV, in a state vulnerable for HBV, even by the current number found in acute hepatitis B type horizontal primary infection, fulminant hepatitis can be a patient. These horizontal for the prevention of infection, there is a demand for universal vaccination in japan HBV is started from.
As described above, HBV HBs-L antigen on the surface of a viral particle, HBs-M antigens, antigen HBs-S 3 different types of proteins (Fig. 1) is present. Japan 2 HBV in a prophylactic vaccine may be used is type, both of which antigen HBs-S, any person may have about 10% in the production of a vaccine HBs antibody was not observed (non-responders to vaccine HB), the benefits of vaccination HBV not be obtained. Therefore, the eradication of HBV infection is horizontal, a small non-response of HBV vaccine, a vaccine is required more powerful. The hepatitis B antigen using HBs-S immune therapy is attempted, sufficient therapeutic effect is not obtained, a more powerful immune therapy is obtained.
Scope of claims (In Japanese)[請求項1]
B型肝炎ウイルスのLタンパク質又はその変異体のみが脂質膜上に集合し、形成された表面抗原粒子を含む、B型肝炎ワクチン。

[請求項2]
Lタンパク質又はその変異体が、以下の(a)又は(b)のタンパク質である請求項1又は2に記載のワクチン。
 (a)配列番号1で表されるアミノ酸配列からなるタンパク質
 (b)配列番号1で表されるアミノ酸配列において、6番目から113番目のPre-S1領域内で6個以下、114番目から162番目のPre-S2領域内で6個以下、163番目から385番目のS領域内で13個以下であって且つ合計で16個以下のアミノ酸が欠失又は置換されたアミノ酸配列からなるタンパク質

[請求項3]
Lタンパク質又はその変異体が、酵母により発現されたものである請求項1又は2に記載のワクチン。

[請求項4]
被検者への投与によりLタンパク質のPre-S1及び/又はPreS2領域に対する抗体が産生される、請求項1~3のいずれか1項に記載のワクチン。

[請求項5]
被検者への投与によりLタンパク質のPre-S1及び/又はPreS2領域に対する細胞性免疫が誘導される、請求項1~4のいずれか1項に記載のワクチン。

[請求項6]
さらにB型肝炎ウイルスのコアタンパク質を含む、請求項1~5のいずれか1項に記載のワクチン。

[請求項7]
被検者への投与により、さらにコアタンパク質に対する抗体が誘導される、請求項6に記載のワクチン。

[請求項8]
被検者への投与により、さらにコアタンパク質に対する細胞性免疫が誘導される、請求項6又は7に記載のワクチン。

[請求項9]
B型肝炎ウイルスに対する中和抗体価が、少なくとも2から1000である請求項1~8のいずれか1項に記載のワクチン。

[請求項10]
B型肝炎ウイルスのヒト肝細胞への結合に対する阻害効果が、少なくとも50~100%である請求項1~9のいずれか1項に記載のワクチン。
  • Applicant
  • ※All designated countries except for US in the data before July 2012
  • TOKYO METROPOLITAN INSTITUTE OF MEDICAL SCIENCE
  • EHIME UNIVERSITY
  • KAGOSHIMA UNIVERSITY
  • BEACLE INC.
  • Inventor
  • KOHARA Michinori
  • SANADA Takahiro
  • HIASA Yoichi
  • KOHARA Koko
  • GOH Yasumasa
  • ODA Yasunori
IPC(International Patent Classification)
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