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.
Paoletti
L C
LC
Channing Laboratory, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA. lpaoletti@channing.harvard.edu
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