IMMUNOGENIC FORMULATION CONTAINING RECOMBINANT LIVE BCG THAT EXPRESS ANTIGENS OF METAPNEUMOVIRUS (HMPV), IN A SUSPENSION PREPARED FROM A LYOPHILISATE, WITHOUT REQUIRING AN ADJUVANT, SUITABLE FOR PHARMACEUTICAL USE

摘要

The present invention relates to an immunogenic formulation to be used in mammals against human Metapneumovirus (hMPV), consisting of a lyophilisate of 1×109 ufc/ml of recombinant BCG that expresses the viral protein P of hMPV (of genogroups A1, A2, B1 and B2). The vaccine is derived from the full or partial product of the P gene of hMPV, capable of being used, stabilised and administered in solution without requiring adjuvants. The preparation can also contain combinations of the aforementioned formulations. The formulation is stabilised by means of lyophilisation (conservation range of between 4° C. and 8° C.) in order to be subsequently reconstituted in an adjuvant-free saline solution prior to use.

主权项

1. An immunogenic formulation that confers protection against infection by metapneumovirus (hMPV) and/or attenuates the pathogenicity caused by hMPV, wherein the formulation comprises one or more recombinant attenuated Mycobacterium strains in an amount that ranges from 104 to 109 bacteria (CFU/dose) per strain, wherein each strain express the P-protein or an immunogenic fragment of the hMPV P-protein, in a pharmacologically appropriate saline buffer.