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 c
onjugated GBS vaccines bottled as liquid preparations showed a potency redu
ction from 100% to less than or equal to 50% in 3 years; whereas all six va
ccines bottled as lyophilized preparations with sucrose excipient exhibited
no loss of potency Juring the same span of time. A reconstituted GBS conju
gate vaccine remained potent and antigenically intact after 31 days' storag
e at 2-8 degreesC. These data suggest that lyophilization in the presence o
f sucrose extends the potency of GBS conjugate vaccines. (C) 2001 Elsevier
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