Immunogenicity and safety of a pneumococcal conjugate 7-valent vaccine in infants with sickle cell disease.

Abstract

OBJECTIVES:

To evaluate safety and immunogenicity of the pneumococcal 7-valent conjugate vaccine (PCV7) when administered to infants with sickle cell disease (SCD) at 2, 3, and 4 months of age with a booster dose of a 23-valent pneumococcal polysaccharide vaccine (PS-23) at 15 to 18 months of age.

METHODS:

This open-label multicenter study in France enrolled 2-month-old infants with SCD. Blood samples for the determination of antibody concentrations to vaccine serotypes were obtained immediately before and 1 month after the primary immunization, and before and 1 month after the PS-23 booster. Local and systemic reactions were recorded on diary cards.

RESULTS:

Of the 51 infants enrolled, 49 received primary immunization and 46 received the booster dose. After primary immunization > or =95% of the subjects had antibody titers > or =0.35 microg/mL for the 7 serotypes. After boosting, geometric mean concentrations were high for all serotypes, ranging from 6.32 microg/mL (serotype 18C) to 29.49 microg/mL (serotype 4). Except for 1 case after administration of the booster dose, all fevers reported were less than 39 degrees C. No vaccine-related serious adverse events were reported.

CONCLUSIONS:

PCV7 administered at 2, 3, and 4 months of age in infants with SCD was well-tolerated, highly immunogenic, and primed for immune memory as indicated by the dramatic response to the PS-23 dose administered at 15-18 months in this study. However, the current recommended schedule is to boost with the PCV7 at 12-15 months of age and for these high-risk children, to enlarge the protection with a subsequent PS-23 dose at 2 years of age.

• Authors: Philippe Reinert, Malika Benkerrou, Mariane de Montalembert, Emmanuelle Lesprit, Isabelle Abadie, Françoise Bernaudin, Catherine Doit, Edouard Bingen, Robert Tetelboum, Eric Bonnet
• Journal: The Pediatric infectious disease journal (Pediatr Infect Dis J) Vol. 26 Issue 12 Pg. 1105-9 (Dec 2007) ISSN: 0891-3668 [Print] United States
• PMID: 18043446 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Bacterial
• Heptavalent Pneumococcal Conjugate Vaccine
• Meningococcal Vaccines
• Pneumococcal Vaccines

Topics

• Anemia, Sickle Cell (immunology)
• Antibodies, Bacterial (blood)
• Hemoglobin SC Disease (immunology)
• Heptavalent Pneumococcal Conjugate Vaccine
• Humans
• Immunization
• Immunization Schedule
• Immunization, Secondary
• Infant
• Meningococcal Vaccines (administration & dosage, adverse effects, immunology)
• Pneumococcal Infections (prevention & control)
• Pneumococcal Vaccines (administration & dosage, adverse effects, immunology)
• Sickle Cell Trait (immunology)
• Streptococcus pneumoniae (immunology)
• Thalassemia (immunology)
• Treatment Outcome