Use of BCG immunogenic formulation expressing a respiratory syncitial virus protein against hMPV
The invention relates to the novel use of an immunogenic formulation containing the bacillus Calmette-Guérin (BCG) strain at a concentration between 10-10° bacteria, expressing at least one protein or immunogenic fragment of respiratory syncytial virus (RSV, Human Orthopneumovirus ), in a pharmaceutically acceptable saline buffer solution because it serves to prepare a vaccine useful to prevent, treat, or attenuate human Metapneumovirus (hMPV) infections.
1 . A method of protecting an individual against human Metapneumovirus (hMPV) infections, the method comprising administering to the individual an immunogenic formulation consisting of a strain of recombinant Bacillus Calmette-Guerin (BCG) at a concentration in a range from 10 4 to 10 9 colony forming units (CFU) per dose in a pharmaceutically acceptable saline buffer solution, wherein the recombinant BCG expresses the N protein of respiratory syncytial virus (RSV) or an immunogenic fragment thereof.
2 . The method of claim 1 , wherein the immunogenic formulation is administered subcutaneously, percutaneously, or subdermally in a pharmaceutically acceptable physiological saline solution.
3 . The method of claim 1 , wherein a gene encoding the N protein of the RSV or the immunogenic fragment thereof is inserted into the genome of the BCG strain to express the N protein of the RSV or the immunogenic fragment thereof.
4 . The method of claim 3 , wherein the expression of the N protein of the RSV or the immunogenic fragment thereof is controlled by an endogenous promoter of the BCG strain which is a constitutive promoter.
5 . The method of claim 1 , wherein the N protein of the RSV or the immunogenic fragment thereof is expressed by the BCG strain in a soluble-cytoplasmic form.
6 . The method of claim 1 , wherein the N protein of the RSV or the immunogenic fragment thereof is expressed in a cell membrane-bound form.
7 . The method of claim 1 , wherein the immunogenic formulation is stabilized by freezing, freeze-drying, or dissolving in a saline buffer prior to the administering.
8 . A method of inducing a humoral response specific to human Metapneumovirus (hMPV) in an animal comprising administering to the animal an immunogenic formulation consisting of a strain of recombinant Bacillus Calmette-Guerin (BCG) at a concentration in a range from 10 4 to 10 9 colony forming units (CFU) per dose in a pharmaceutically acceptable saline buffer solution, wherein the recombinant BCG expresses the N protein of RSV or an immunogenic fragment thereof.
9 . The method of claim 8 , wherein the method induces anti-hMPV IgG antibodies.