Potency of clinical group B streptococcal conjugate vaccines.
The potency of clinical group B streptococcal (GBS) capsular polysaccharide-protein conjugate vaccines has been assessed with use of a mouse maternal vaccination-neonatal pup challenge model of GBS disease. Two of the three conjugated GBS vaccines bottled as liquid preparations showed a potency reduction from 100% to < or = 50% in 3 years; whereas all six vaccines bottled as lyophilized preparations with sucrose excipient exhibited no loss of potency during the same span of time. A reconstituted GBS conjugate vaccine remained potent and antigenically intact after 31 days' storage at 2-8 degrees C. These data suggest that lyophilization in the presence of sucrose extends the potency of GBS conjugate vaccines.
Channing Laboratory, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA. lpaoletti@channing.harvard.edu
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Paoletti
D000818:Animals; D000831:Animals, Newborn; D021461:Animals, Outbred Strains; D004355:Drug Stability; D005260:Female; D005612:Freeze Drying; D006801:Humans; D007112:Immunity, Maternally-Acquired; D051379:Mice; D011135:Polysaccharides, Bacterial / Q000008:administration & dosage / Q000276:immunology; D011247:Pregnancy; D022541:Streptococcal Vaccines / Q000008:administration & dosage / Q000494:pharmacology*; D013292:Streptococcus agalactiae / Q000276:immunology* / Q000472:pathogenicity; D013745:Tetanus Toxoid / Q000008:administration & dosage; D018074:Vaccines, Conjugate / Q000008:administration & dosage / Q000494:pharmacology
D011135:Polysaccharides, Bacterial; D022541:Streptococcal Vaccines; D013745:Tetanus Toxoid; D018074:Vaccines, Conjugate