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Pediatric Infectious Disease Journal:
doi: 10.1097/INF.0b013e3181d99345
Original Studies

Immunogenicity of Alternative Regimens of the Conjugated 7-Valent Pneumococcal Vaccine: A Randomized Controlled Trial

Givon-Lavi, Noga PhD; Greenberg, David MD; Dagan, Ron MD

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Abstract

Background: The 7-valent CRM197 pneumococcal conjugated vaccine (PCV7) was originally licensed using 3 primary doses during infancy and a booster in the second year of life. We compared the originally licensed regimen to 2 widely used alternative regimens.

Methods: Five hundred forty-three infants were randomized to receive PCV7 at 2, 4, 6, and 12 months (3 + 1), at 4, 6, and 12 months (2 + 1), or at 2, 4, and 6 months (3 + 0). Blood was drawn at 2, 7, 13, and 19 months. Serotype-specific IgG concentrations were determined by ELISA.

Results: In the 2 + 1 group, postprimary IgG concentrations against serotypes 6B, 14, 18C, and 23F were reduced compared with the 3 + 1 or 3 + 0 groups. Both 3 + 1 and 2 + 1 groups showed marked booster response, but the 2 + 1 group had reduced concentrations against serotypes 6B, 18C, 23F. At 19 months, IgG antibodies decreased in both 3 + 1 and 2 + 1 groups but the 2 + 1 group had significantly lower concentrations against serotypes 6B, 18C, and 23F. IgG concentrations decreased in the 3 + 0 group during the second year and were significantly lower than those of 3 + 1 and 2 + 1 for all serotypes at 13 and 19 months.

Conclusions: Significant differences in immunogenicity were documented between the reduced and the licensed regimens. The clinical implications of these differences require further studies.

© 2010 Lippincott Williams & Wilkins, Inc.

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