Randomized, double-blind, phase 2 clinical trial controlled with conventional Bacillus Calmette-Guérin (BCG) vaccine to evaluate the safety and immunogenicity of a recombinant BCG vaccine that expresses the respiratory syncytial virus (RSV) nucleoprotein (N) (rBCG-N-RSV) in adults over 60 years of age.

000 CFU in adults over 60 years of age., The present Phase 2 clinical study will evaluate the safety and immunogenicity of the immunogenic formulation cGMP rBCG-N-RSV of 100

Occurrence, intensity, and duration of the local solicited AEs (evolution of the "flare-up") until the generation of the scar., Occurrence, intensity and duration of unsolicited AEs during the 6-month follow-up., Occurrence of AEs during the 6-month follow-up duration., Alterations to the hemogram and/or biochemical profile., Production of IFN-γ, TNF-α, IL-2, IL-4, Granzyme B and IL-10 by T cells upon exposure to purified protein derivative (PPD) mycobacterial antigen., Production of IFN-γ, TNF-α, IL-2, IL-4, Granzyme B and IL-10 by T cells upon exposure to recombinant RSV nucleoprotein antigen.

Presence and titers of serum IgG antibodies against Purified Protein Derived Mycobacterial antigen (PPD)., Presence and titers of serum IgG against RSV nucleoprotein.

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