Compositions and method for preventing reactogenicity...

A - Human Necessities – 61 – K

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A61K 39/15 (2006.01)

Patent

CA 2398428

The present invention provides compositions for making a medicament and methods for the administration of a vaccine compositions for protection against human rotaviral disease without significant reactogenicity. Human x rhesus reassortant rotavirus compositions were made which when administered during the first 7 to about 10 days of life, provided a composition which was non-reactogenic followed by booster immunizations at 16 to 18 weeks or 14 to 20 weeks, up to 1 year of age. The immune response induced by the initial neonatal administration of the live rotavirus vaccine composition protects the infant from the reactogenicity of the composition when administered as a second vaccine dose at or after 2 months of age. Administration of the immunogenic composition also is expected to ablate or significantly diminish the increase in the excess of intussusception observed 3 to 7 days following administration of the initial dose of rotavirus vaccine at about 2 to 4 months.

Cette invention se rapporte à des compositions servant à fabriquer un médicament, et à des procédés pour l'administration de compositions de vaccin de protection contre les maladies rotavirales humaines, sans réactogénicité notable. On a fabriqué des compositions de rotavirus réassortis de rhésus x humain qui, après administration pendant les 7 à environ 10 premiers jours de vie, ont formé une composition sans réactogénicité, suivie par une stimulation de l'immunisation à 16-18 semaines ou à 14-20 semaines, et jusqu'à une année de vie. La réponse immunitaire induite par l'administration initiale de cette composition de vaccin de rotavirus vivant à un nouveau-né protège l'enfant contre la réactogénicité de la composition, lorsque celle-ci est administrée sous la forme d'une seconde dose de vaccin à deux mois de vie ou après deux mois de vie. On s'attend en outre à ce que l'administration de cette composition immunogène supprime ou diminue notablement l'augmentation d'une intussusception excédentaire, observée 3 à 7 jours après l'administration de la dose initiale de vaccin de rotavirus à environ 2-4 mois.

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