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MUCOSAL VACCINE achieved

Foreign code F120006532
File No. S2010-0682-C0
Posted date May 8, 2012
Country WIPO
International application number 2011JP054586
International publication number WO 2011108521
Date of international filing Mar 1, 2011
Date of international publication Sep 9, 2011
Priority data
  • P2010-045205 (Mar 2, 2010) JP
Title MUCOSAL VACCINE achieved
Abstract Disclosed is a mucosal vaccine which is characterized by comprising: (a) an AD vehicle that comprises a lipid and a synthetic peptide which comprises the amino acid sequence of KnLm (wherein n represents a number of 4-8 and m represents a number of 11-20); (b) a carboxyvinyl polymer; and (c) an antigen protein in such an amount that does not produce, by itself, mucosal immunity IgA and blood immunity IgG in such amounts that effective immune induction and protection against the infection can be achieved. The mucosal vaccine is also characterized by producing antigen-specific mucosal immunity IgA and blood immunity IgG in such amounts that effective immune induction and protection against the infection can be achieved. The mucosal vaccine has higher antibody producing ability than conventional mucosal vaccines, and is thus capable of achieving excellent effects with an extremely small amount of antigen.
Outline of related art and contending technology BACKGROUND ART
And 2 is Patent Document 1, the conventional inactivated vaccines or the like that the disadvantages of the toxoid, such as immune adjuvants and mucosal vaccine development of current has been described in detail.
These Patent Documents 1, as described in 2, such as conventional intramuscular subcutaneously inoculated into from a vaccine, is the root of a natural infection of the virus to induce the production of the antibody IgA mucosa of switching to the mucosal vaccine need, wider and deeper recognized. In particular, as the next generation vaccine 21 st century, the production of antibodies IgA, inducing an immune response or mucosal local immune, so-called mucosal vaccine development and practical use is possible for the deficiencies of all over the world, has not been achieved yet.
The present inventors to solve this problem, and/or pulmonary surfactant C B and lung surfactant, a lipid and a complex of antigen and drug vehicle (AD), from this AD vehicle mucosal vaccine antigen, and filed a patent application (Patent Document 1) are. Further the present inventors have found, and the amount of the antigen (V) vehicle AD (A) the amount of the weight ratio of V/A by adjusting the size, the specific production and selection of antibodies IgA IgA, both IgG antibody production and found that can be converted to, the mechanism of action of this mucosal vaccine and filed a patent (Patent Document 2). These patents Document 1, is 2, a fragment of a lung surfactant C B and the validity of the (peptide) is disclosed.
Further the present inventors have, for various variants of pulmonary surfactant fragment antibody production enhancing effect as a result of studies, Patent Document 1, a partial peptide disclosed in 2 smaller in size than that in spite of a peptide, a potentiation or a strong induction of antibody production, in particular, production of secretory IgA antibodies alone, the, both IgG and secretory IgA antibody production in the blood that has superior effective guidance has the effect of synthetic peptide KnLm (however n is 4-8, m is 11-20) and the vehicle components AD, this AD vehicle with antigen from the mucosal vaccine, and filed a patent application (Patent Document 3) are.
In addition, take the same route of administration of mucosal vaccine is a nasal, increase the viscosity thereof, hay fever or allergy to continuously in order to demonstrate the efficacy of carboxyvinyl polymer (CVP) hydroxypropyl cellulose (HPC) or other widely used, including other sodium alginate thickening gelling agent is used. For example, containing HPC (Patent Document 4) or mucosal vaccine, vaccine formulations containing mucosal application type CVP (Patent Document 5) influenza vaccine and intranasal spray administration (Patent Document 6) and the like are also known. In addition, the patent document 7, antigen, adjuvant particularly Poly (I.C.) and thickener (sodium alginate and the like) is made of a vaccine for mucosal administration disclosed.
Scope of claims (In Japanese)請求の範囲 [請求項1]
以下の組成:
(a)KnLm(ただしnは4-8、mは11-20)のアミノ酸配列からなる合成ペプチドと脂質とからなるADビークル;
(b)カルボキシビニルポリマー;および
(c)単独では、効果的な免疫誘導と感染防御効果を生じさせる量の粘膜免役IgAおよび血中免疫IgGを産生させることのない量の抗原蛋白
を含み、効果的な免疫誘導と感染防御効果を生じさせる量の抗原特異的粘膜免役IgAおよび血中免疫IgGを産生させることを特徴とする粘膜ワクチン。

[請求項2]
抗原蛋白(c)が、ADビークル(a)との組合せ、またはカルボキシビニルポリマー(b)との組合せによっても効果的な免疫誘導と感染防御効果を生じさせる量の抗原特異的粘膜免役IgAおよび血中免疫IgGを産生させることのない量である請求項1の粘膜ワクチン。

[請求項3]
合成ペプチドが、配列番号1または2のアミノ酸配列からなる請求項1の粘膜ワクチン。

[請求項4]
脂質が、ホスファチジルコリン、ジパルミトイルホスファチジルコリン、ホスファチジルセリン、ホスファチジルグリセロール、ホスファチジルイノシトール、ホスファチジルエタノールアミン、ホスファチジン酸、ラウリル酸、ミリスチン酸、パルミチン酸、ステアリン酸およびオレイン酸の少なくとも1種である請求項1の粘膜ワクチン。

[請求項5]
脂質が、ジパルミトイルホスファチジルコリン、ホスファチジルグリセロールおよびパルミチン酸の3種脂質混合物である請求項3の粘膜ワクチン。

[請求項6]
抗原蛋白が病原体に由来の不活化抗原、精製抗原、部分精製抗原、リコンビナント抗原又は無毒化毒素、アレルギーの原因となるアレルゲンである請求項1の粘膜ワクチン。

[請求項7]
以下の組成:
(a)KnLm(ただしnは4-8、mは11-20)のアミノ酸配列からなる合成ペプチドと脂質とからなるADビークル;
(b)カルボキシビニルポリマー;および
(c)単独では、効果的な免疫誘導を生じさせる量の粘膜免役IgAおよび血中免疫IgGを産生させることのない量の抗原
を含み、効果的な免疫誘導を生じさせる量の抗原特異的粘膜免役IgAおよび血中免疫IgGを産生させることを特徴とする粘膜ワクチンの製造法であって、
(1)前記(a)および(c)を水に懸濁し、
(2)加温と攪拌とを1回以上反復し、
(3)凍結乾燥し、
(4)凍結乾燥体を生理食塩水に懸濁して所定濃度に調製し、
(5)前記(b)の溶液を加える、
ことを特徴とする製造方法。

  • Applicant
  • ※All designated countries except for US in the data before July 2012
  • TOKUSHIMA UNIVERSITY
  • Inventor
  • KIDO Hiroshi
  • MIZUNO Dai
IPC(International Patent Classification)
Specified countries National States: AE AG AL AM AO AT AU AZ BA BB BG BH BR BW BY BZ CA CH CL CN CO CR CU CZ DE DK DM DO DZ EC EE EG ES FI GB GD GE GH GM GT HN HR HU ID IL IN IS JP KE KG KM KN KP KR KZ LA LC LK LR LS LT LU LY MA MD ME MG MK MN MW MX MY MZ NA NG NI NO NZ OM PE PG PH PL PT RO RS RU SC SD SE SG SK SL SM ST SV SY TH TJ TM TN TR TT TZ UA UG US UZ VC VN ZA ZM ZW
ARIPO: BW GH GM KE LR LS MW MZ NA SD SL SZ TZ UG ZM ZW
EAPO: AM AZ BY KG KZ MD RU TJ TM
EPO: AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR
OAPI: BF BJ CF CG CI CM GA GN GQ GW ML MR NE SN TD TG
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