The present invention discloses the preparation of a pneumococcal conjugate combination vaccine, belonging to the technical field of biopreparation. The composition includes 26 different pneumococcal
polysaccharide-
protein conjugates. The pneumococcal polysaccharides include 26 serotypes, namely 1, 2, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 24F, 33F and 35B. The
carrier protein used in the conjugate is
tetanus toxoid (TT). The
polysaccharide-
protein conjugate
stock solution is prepared by covalently binding the
polysaccharide and TT through a
cyanide activation method. The polysaccharide-
protein conjugate
stock solution is then adsorbed with aluminum
adjuvant in an appropriate proportion to obtain the
pneumococcal conjugate vaccine. In particular, the pneumococcal polysaccharides used in the present invention do not need to undergo a
degradation reaction, effectively protecting the
antigenicity of the polysaccharide. The production of three consecutive batches of conjugate
stock solution and vaccine is carried out, and the conjugate yield and various
verification indexes are stable. The results of non-
clinical safety evaluation studies show that the vaccine has good safety and
immunogenicity. The
pneumococcal conjugate vaccine prepared by the present invention is used for the immunoprevention of
pneumococcal infections of related serotypes.