Stability testing in Haemophilus influenzae type b conjugate vaccines.
Coupling T-cell-independent antigens such as the capsular-polysaccharide (PRP) of H. influenzae type b (HIB) to a T-cell-dependent protein-carrier enhances the immune response, particularly in individuals who are poor responders to such antigens. An adequate immunogenicity is dependent upon the characteristics of the PRP antigen, the protein carrier, the efficiency of conjugation and the stability of the conjugate. Since adequate immunogenicity tests are not available, stability studies in such products are essentially confined to molecular size distribution and determination of the degree of conjugation. A better understanding of the factors involved in stability and an improvement of the testing methods are highly desirable.
Klug
B
B
Department of Bacteriology, Paul-Ehrlich-Institut, Langen, Germany.
D016667:Bacterial Capsules; D001425:Bacterial Outer Membrane Proteins / Q000737:chemistry; D002850:Chromatography, Gel; D004168:Diphtheria Toxoid / Q000737:chemistry; D004355:Drug Stability; D004356:Drug Storage; D018073:Haemophilus Vaccines / Q000737:chemistry*; D008970:Molecular Weight; D011135:Polysaccharides, Bacterial / Q000737:chemistry*; D013745:Tetanus Toxoid / Q000737:chemistry; D018074:Vaccines, Conjugate / Q000737:chemistry*
D001425:Bacterial Outer Membrane Proteins; D004168:Diphtheria Toxoid; D018073:Haemophilus Vaccines; C055753:Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate; C044237:Haemophilus influenzae type b polysaccharide vaccine; C052180:Haemophilus influenzae type b-polysaccharide vaccine-diphtheria toxoid conjugate; C061964:Haemophilus influenzae-type b polysaccharide-Neisseria meningitidis outer membrane protein conjugate vaccine; D011135:Polysaccharides, Bacterial; D013745:Tetanus Toxoid; D018074:Vaccines, Conjugate