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VACCINE PREPARATION AGAINST MALARIAL PARASITE INFECTION

Foreign code F150008262
Posted date Mar 27, 2015
Country WIPO
International application number 2014JP002071
International publication number WO 2014171116
Date of international filing Apr 10, 2014
Date of international publication Oct 23, 2014
Priority data
  • P2013-087431 (Apr 18, 2013) JP
Title VACCINE PREPARATION AGAINST MALARIAL PARASITE INFECTION
Abstract The present invention relates to a vaccine preparation against malarial parasite infection. More specifically, the invention relates to a vaccine preparation containing a liposome preparation in which a soluble protein derived from a malarial parasite is encapsulated by a liposome having on the surface an oligosaccharide capable of bonding to a sugar chain-recognizing molecule on the surface of an antigen presenting cell.
Outline of related art and contending technology BACKGROUND ART
Malaria in the tropical, subtropical areas 70 distributed or more countries of protozoan infection. 3-5 million year all over the world, an accumulated total of about 8 million patients infected with malaria, 100-150 million people have been reported to die of malaria.
A single-cell organism is a pathogen of malaria in a malaria parasite, Plasmodium falciparum, P. falciparum (p. vivax) 3, 4 P. falciparum (p. malariae), oval (p. ovale) 4 of the malaria parasite species present. In particular Plasmodium falciparum malaria by heavy symptoms.
Plasmodium parasite, by female Anopheles mosquitoes to a bloodsucking with transmission, an anti-malarial sporozoite carrying human with respect to the host. Sporozoite is, carried by the blood to the liver, hepatocytes grown in, changes to the life cycle of the merozoite that is in the following forms. The infected hepatocytes rupture, merozoite is released in the blood stream. Merozoite infected red blood cells is then, in part, in red blood cells to male and female reproductive the mother cell. And another is a bloodsucking mosquitoes of infection of the host, supplied with the male and female reproductive cell is, in the interior of the female mosquitoes to fuzed liverstage. This is a bloodsucking mosquitoes can be the next host, host yet another liverstage-transmitted.
Naturally infected with the malaria parasite in the human host, anti-malaria antibody is produced. However, only an antibody is produced, the malaria parasite as protective immunity (humoral immunity) is the ability to neutralize not held, having a memory characteristic sufficient also cell-mediated immunity is not caused. As a result of infection can occur many times, complicating disease treatment and prevention method according to the embodiment.
The highest malaria as a vaccine is that the protective effect is confirmed, the malaria parasite infectious forms liverstage is inactivated by irradiation of radiation is a vaccine. However, because of the need for a high degree of production facility, in a region to develop and unsuited for widespread use. Therefore, a powerful and simple preparation is the development of new vaccines has been expected. However, a primate human malaria is basically does not infect only, in order to confirm the effectiveness of the vaccine, monkey, or the experiments using human, mouse malarial parasites to infect mouse cannot be performed only by the simulated experiments. Therefore, the development of new vaccines for human malarial are extremely difficult to (non-patent document 1, non-patent document 2).
Therefore, the inactivated sporozoite vaccine antigens which have an effect equivalent to that of purified protein, produced as a subunit vaccine (the peptide) of the water-based and is considered to be practical. Up to now, some of the candidate molecule is found in the malaria vaccine, a portion of the drug in a clinical is started, and to confirm the effectiveness has not been reported (non-patent document 3).
In addition, compared to the live vaccine, productivity and storage of handling such as very simple DNA vaccine is known as a vaccine. Possible DNA vaccine is easy to manufacture since, against early mutation, improved quickly can be to provide a vaccine. However, the vaccine is effective against malaria falciparum DNA has not been developed yet (non-patent document 4).
In this way, effective against malaria vaccine is currently not obtained. Key is malaria vaccine development, how strong immunogenicity and antigen-presenting cells is transferred to the antigen protein, and a sufficient antigen-specific antibody production to induce cell-mediated immunity.
Delivery of the antigen protein is, coated with oligomannose sugar chain such as a liposome, a liposome having the oligosaccharide antigen on the surface of the encapsulate is known (patent document 1, non-patent document 5-8). The inventors have found that, on the surface of a liposome having the oligosaccharide to soluble antigen derived from a protozoan neospora sealed (Neospora caninum), mice can be immunized in this liposome, neospora Th1 type immunity induced significantly with respect to the protozoa, vertical transmission and the body to control the propagation of the protozoa can be reported (patent document 2, non-patent document 9). However, a P. falciparum antigen will be, yet such formulation not attempt was made.
Scope of claims (In Japanese)請求の範囲 [請求項1]
 マラリア原虫由来の抗原たんぱく質circumsporozoite protein (CSP)若しくはmerozoite surface protein 1 (MSP1)、又はその免疫学的に活性な変異体若しくは誘導体、あるいはその免疫学的に活性な断片を、抗原提示細胞表面の糖鎖認識分子に結合しうるオリゴ糖を表面に有するリポソームに封入してなるリポソーム製剤を含むマラリア原虫感染症に対するワクチン製剤。

[請求項2]
 免疫学的に活性な断片が、CSP若しくはMSP1、又はその免疫学的に活性な変異体若しくは誘導体のC末端領域を含む断片である、請求項1に記載のワクチン製剤。

[請求項3]
 免疫学的に活性な断片が、CSP又はMSP1のC末端100アミノ酸残基のうち、少なくとも連続した8~50アミノ酸残基を含む断片である、請求項1に記載のワクチン製剤。

[請求項4]
 免疫学的に活性な断片が、以下の(a)~(c)のいずれかである、請求項1に記載のワクチン製剤。
(a) 配列番号2の186~332位に示されるアミノ酸配列を含むタンパク質、
(b) 配列番号2の186~332位に示されるアミノ酸配列において1又は数個のアミノ酸が欠失、置換もしくは付加されたアミノ酸配列を含み、マラリア原虫に対する免疫応答を誘導しうるタンパク質、
(c) 配列番号2の186~332位に示されるアミノ酸配列と60%以上の同一性を有するアミノ酸配列を含み、マラリア原虫に対する免疫応答を誘導しうるタンパク質

[請求項5]
 免疫学的に活性な断片が、以下の(d)~(f)のいずれかである、請求項1に記載のワクチン製剤。
(d) 配列番号4の1608~1768位に示されるアミノ酸配列を含むタンパク質、
(e) 配列番号4の1608~1768位に示されるアミノ酸配列において1又は数個のアミノ酸が欠失、置換もしくは付加されたアミノ酸配列を含み、マラリア原虫に対する免疫応答を誘導しうるタンパク質、
(f) 配列番号4の1608~1768位に示されるアミノ酸配列と60%以上の同一性を有するアミノ酸配列を含み、マラリア原虫に対する免疫応答を誘導しうるタンパク質

[請求項6]
 前記抗原提示細胞表面の糖鎖認識分子がマンノース・レセプターである、請求項1~5のいずれか1項に記載のワクチン製剤。

[請求項7]
 前記オリゴ糖が2~11の糖残基からなる、請求項1~6のいずれか1項に記載のワクチン製剤。

[請求項8]
 前記オリゴ糖が3~5の糖残基からなる、請求項1~7のいずれか1項に記載のワクチン製剤。

[請求項9]
 前記オリゴ糖が2以上のマンノース糖残基を含むものである、請求項1~8のいずれか1項に記載のワクチン製剤。

[請求項10]
 さらに製薬上許容しうる担体を含む、請求項1~9のいずれか1項に記載のワクチン製剤。

[請求項11]
 皮下、皮内、経口、腹腔又は経鼻投与されるものである、請求項10に記載のワクチン製剤。

  • Applicant
  • ※All designated countries except for US in the data before July 2012
  • OBIHIRO UNIVERSITY OF AGRICULTURE AND VETERINARY MEDICINE
  • TOKAI UNIVERSITY EDUCATIONAL SYSTEM
  • Inventor
  • NISHIKAWA, Yoshifumi
  • KURODA, Yasuhiro
  • KOJIMA, Naoya
IPC(International Patent Classification)
Specified countries National States: AE AG AL AM AO AT AU AZ BA BB BG BH BN 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 IR IS JP KE KG 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 PA PE PG PH PL PT QA RO RS RU RW SA 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 RW SD SL SZ TZ UG ZM ZW
EAPO: AM AZ BY KG KZ 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 KM ML MR NE SN TD TG
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