Kishore Turaga,
Author Of 1 Presentation
SAFETY AND IMMUNOGENICITY OF A 14VALENT PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (PCV14) (ID 1197)
Abstract
Background
A Pneumococcal conjugate vaccine containing 14 serotypes (polysaccharide serotypes 1,3,4,5,6B,7F,9V,14,18C,19A,19F,22F,23F, and 33F - all separately conjugated to CRM197 and formulated) was manufactured and tested for safety and immunogenicity in rabbits.
Methods
A Phase 1 safety and immunogenicity study was completed in 24 healthy adults. A separate Phase2 safety and immunogenicity study in 12 to 23 month old toddlers was conducted with two dose (0 and day 60) administration. The study had two arms (60 in each arm) with Prevnar13 as comparator.
Results
The PCV14 was well tolerated in toddlers and no SAE were reported. The IgG GMC for all serotypes post second dose were ≥ 0.35 mcg/mL in the PCV14 group. GMFR (depending on serotype) ranged from 4.31 to 57.72. In the Prevnar13 group (depending on serotype) GMFR ranged from 4.19 to 77.86. The MOPA indicated that the proportion (%) of subjects with tires ≥1:8 in the PCV14 group was 86.21 to 98.28 while in Prevnar13 group the range was from 98.33 to 100.
Conclusions
PCV14 was safe, well tolerated in adults and toddlers, and was immunogenic with GMC and MOPA titres well above the defined seroprotection criteria. Clinical studies in infants in larger target population are planned.