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INTRANASAL OR INHALATIONAL ADMINISTRATION OF VIROSOMES
专利权人:
ABBOTT BIOLOGICALS B. V.
发明人:
KERSTEN, ALEXANDER J.,克斯顿 亚历山大J.,克斯頓 亞歷山大J.,GEREZ, LISYA,葛兹 利沙,葛茲 利沙,SCHOEN, PIETER J.,史丘恩 彼得J.,史丘恩 彼得J.,NAUTA, JOZEF J. P.,烙塔 乔瑟夫J. P.,烙塔 喬瑟夫J. P.,VAN RHEINECK LEYSSIUS, DORINE H.,凡英克利苏斯 多林H.,凡英克利蘇斯
申请号:
TW096109319
公开号:
TWI397419B
申请日:
2007.03.19
申请国别(地区):
TW
年份:
2013
代理人:
摘要:
The present invention provides a composition of influenza virosomes comprising reconstituted envelopes of said virus, wherein the viral envelopes are entirely derived from influenza viral particles, wherein no lipid is added from an external source to the reconstituted virosomes, wherein the virosomes comprise the influenza antigens haemagglutinin and/or neuraminidase or derivatives thereof, wherein no separate adjuvant and/or immune stimulator is added to the composition, and wherein the composition is for intranasal or inhalational administration, which composition is characterized in that a single intranasal or inhalational administration to a human being is sufficient for the induction of a systemic immune response and/or a local immune response and/or a cytotoxic lymphocytes response against said influenza antigens, which systemic response is in accordance with the CHMP criteria for influenza vaccine, and wherein the dose of haemagglutinin per viral strain per intranasal or inhalational administration is lower than or equal to 30 pg. The invention also provides the use of reconstituted influenza virosomes for the manufacture of said composition, and accordingly manufactured vaccine formulations.本發明提供了流感病毒顆粒的組合物,所述病毒顆粒包含所述病毒的重構外殼,其中,所述病毒外殼完全從流感病毒粒獲得,其中,沒有從外界來源向重構病毒顆粒加入脂類,其中,病毒顆粒包含流感抗原血球凝集素和/或神經氨酸酶或其衍生物,其中,沒有向所述組合物加入單獨的佐劑和/或免疫刺激劑’以及其中,所述組合物作為鼻內或吸入給藥配方製劑來設計,所述組合物特徵在於,所述配方製劑向人類的單次鼻內或吸入給藥足以誘導抵抗所述流感抗原的全身性免疫應答和/或局部免疫應答和/或細胞毒性淋巴細胞誘導,所述全身性應答能符合針對流感疫苗的CHMP標準,以及其中,每種病毒毒株每次鼻內或吸入給藥的血球凝集素劑量等於或低於30 μ g。本發明還提供了重構的流感病毒顆粒用於製造所述組合物的用途,以及由此製造的疫苗配方製劑。
来源网站:
中国工程科技知识中心
来源网址:
http://www.ckcest.cn/home/

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