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Immunogenicity and safety of a pneumococcal conjugate 7-valent vaccine in infants with sickle cell disease.
Pediatr Infect Dis J. 2007 Dec; 26(12):1105-9.PI

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+Show Affiliations

CHI Créteil, France. preinert@club-internet.frNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18043446

Citation

Reinert, Philippe, et al. "Immunogenicity and Safety of a Pneumococcal Conjugate 7-valent Vaccine in Infants With Sickle Cell Disease." The Pediatric Infectious Disease Journal, vol. 26, no. 12, 2007, pp. 1105-9.
Reinert P, Benkerrou M, de Montalembert M, et al. Immunogenicity and safety of a pneumococcal conjugate 7-valent vaccine in infants with sickle cell disease. Pediatr Infect Dis J. 2007;26(12):1105-9.
Reinert, P., Benkerrou, M., de Montalembert, M., Lesprit, E., Abadie, I., Bernaudin, F., Doit, C., Bingen, E., Tetelboum, R., & Bonnet, E. (2007). Immunogenicity and safety of a pneumococcal conjugate 7-valent vaccine in infants with sickle cell disease. The Pediatric Infectious Disease Journal, 26(12), 1105-9.
Reinert P, et al. Immunogenicity and Safety of a Pneumococcal Conjugate 7-valent Vaccine in Infants With Sickle Cell Disease. Pediatr Infect Dis J. 2007;26(12):1105-9. PubMed PMID: 18043446.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Immunogenicity and safety of a pneumococcal conjugate 7-valent vaccine in infants with sickle cell disease. AU - Reinert,Philippe, AU - Benkerrou,Malika, AU - de Montalembert,Mariane, AU - Lesprit,Emmanuelle, AU - Abadie,Isabelle, AU - Bernaudin,Françoise, AU - Doit,Catherine, AU - Bingen,Edouard, AU - Tetelboum,Robert, AU - Bonnet,Eric, PY - 2007/11/29/pubmed PY - 2008/1/3/medline PY - 2007/11/29/entrez SP - 1105 EP - 9 JF - The Pediatric infectious disease journal JO - Pediatr Infect Dis J VL - 26 IS - 12 N2 - 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. SN - 0891-3668 UR - https://www.unboundmedicine.com/medline/citation/18043446/Immunogenicity_and_safety_of_a_pneumococcal_conjugate_7_valent_vaccine_in_infants_with_sickle_cell_disease_ L2 - https://doi.org/10.1097/INF.0b013e31814614c6 DB - PRIME DP - Unbound Medicine ER -