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COMBINED VACCINE AND METHOD OF ITS PRODUCTION (OPTIONS)
专利权人:
СЕРУМ ИНСТИТЬЮТ ОФ ИНДИА ПРАЙВИТ ЛИМИТИД;ЗЕ СЕНТЭЗ ФО ДИЗИЗ КОНТРОУЛ ЭНД ПРЕВЕНШН (СиДиСи)
发明人:
Раджив Мхаласакант,Самбхаджи Шанкар,Джагдиш Камаладжи,Раджендра Нараян,Равинда Бапурао,Абхайджит Санджив,Баомин,Роджер
申请号:
EA201900117
公开号:
EA201900117A1
申请日:
2017.08.24
申请国别(地区):
EA
年份:
2019
代理人:
摘要:
The present invention relates to a stable, immunogenic combination vaccine (s) containing a mixture of antigens to prevent and prevent infections caused by rotavirus, polio virus, Haemophilus influenzae, Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis and hepatitis B. In particular, in accordance with The present invention provides a multivalent combination vaccine comprising i) a substantially reduced dose of Salk IPV or Sabin IPV (IPV) antigens obtained using advanced inactivation methods. after exposure to formaldehyde and adsorption on aluminum hydroxide, which results in maximum recovery of the D antigen, and ii) heat-inactivated injectable rotavirus antigen (antigens) obtained from rotavirus strains (CDC-9), which provides broad cross-immunity to the strains human rotavirus, iii) a Hib PRF carrier protein conjugate having increased stability and immunogenicity, wherein said Hib PRF carrier protein conjugate is initially prepared using a new about the conjugation process and then mixed at a low temperature in the presence of a stabilizer to minimize the release of free PRF, iv) a whole-cell pertussis antigen with increased immunogenicity and stability, obtained by adding whole-cell pertussis antigen to the mixture at a later stage, which minimizes degradation by hydrolysis, v) homogeneous fractions of diphtheria toxoid and tetanus toxoid obtained by removing unwanted aggregates using gel Penetration chromatography. The invention also discloses a method for producing such a stable and immunogenic vaccine by i) individually adsorbing a reduced dose of IPV antigens, IRV antigens on aluminum hydroxide and maintaining the other antigen (s) in the non-adsorbed state, or adsorbed on aluminum phosphate, aluminum hydroxide, or a combination of hydroxide aluminum and aluminum phosphate state; and ii) using a specific order of addition of antigens during mixing.Настоящее изобретение относится к стабильной, иммуногенной комбинированной вакцине (вакцин
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中国工程科技知识中心
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