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13-valent pneumococcal conjugate vaccine (PCV13) is immunogenic and safe in children 6-17 years of age with sickle cell disease previously vaccinated with 23-valent pneumococcal polysaccharide vaccine (PPSV23): Results of a phase 3 study.
Pediatr Blood Cancer. 2015 Aug; 62(8):1427-36.PB

Abstract

BACKGROUND

A large population of older children with sickle cell disease (SCD) is currently vaccinated with only 23-valent pneumococcal polysaccharide vaccine (PPSV23). In immunocompetent adults, PPSV23 vaccination reduces immune responses to subsequent vaccination with a pneumococcal vaccine. The 13-valent pneumococcal conjugate vaccine (PCV13), which addresses this limitation, may offer an advantage to this population at high risk of pneumococcal disease.

PROCEDURE

Children with SCD 6-17 years of age previously vaccinated with PPSV23 at least 6 months before study enrollment received two doses of PCV13 6 months apart. Anti-pneumococcal polysaccharide immunoglobulin G (IgG) geometric mean concentrations (GMCs) and opsonophagocytic activity (OPA) geometric mean titers (GMTs) were measured before, 1 month after each administration, and 1 year after the second administration.

RESULTS

Following each PCV13 administration, IgG GMCs and OPA GMTs significantly increased, and antibody levels after doses 1 and 2 were generally comparable. Antibody levels declined over the year following dose 2. At 1 year after the second administration, OPA GMTs for all and IgG GMCs for most serotypes remained above pre-vaccination levels. Most adverse events were due to vaso-occlusive crises, a characteristic of the underlying condition of SCD.

CONCLUSIONS

Children with SCD who were previously vaccinated with PPSV23 responded well to 1 PCV13 dose, and a second dose did not increase antibody response. PCV13 antibodies persisted above pre-vaccination levels for all serotypes 1 year after dose 2. Children with SCD may benefit from at least one dose of PCV13.

Authors+Show Affiliations

Hôpital Necker-Enfants Malades, Service de Pédiatrie, Paris, France.Department of Pediatrics and Adolescent Medicine, American University of Beirut, Beirut, Lebanon.Vaccine Research, Pfizer Ltd, Tadworth, Berkshire, UK.RHUH, Rafic Hariri University Hospital, Beirut, Lebanon.University of Alabama at Birmingham, Birmingham, Alabama.Pediatric Cairo University Hospital (Abu Elreesh - Almoneera), Egypt.Hematology unit, Children Hospital, Ain Shams University, Cairo, Egypt.Ospedale San Luigi Gonzaga, Orbassano, Torino University, Italy.Vanderbilt University Medical Center, Nashville, Tennessee.Evelina Children's Hospital, St Thomas' Hospital, London, UK.King's College Hospital, London, UK.Vaccine Institute, St Georges, University of London, London, UK.Royal London Hospital, London, UK.Children's Hospital at Montefiore, Bronx, New York.King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia.Unità Operativa di Epidemiologia Ospedale Bambino Gesù, Roma, Italy.Vaccines, Pfizer Inc, Collegeville, Pennsylvania.Vaccine Research, Pfizer Inc, Pearl River, New York.Vaccine Research, Pfizer Inc, Pearl River, New York.Vaccine Research, Pfizer Inc, Pearl River, New York.Vaccine Research, Pfizer Inc, Pearl River, New York.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study

Language

eng

PubMed ID

25810327

Citation

De Montalembert, Mariane, et al. "13-valent Pneumococcal Conjugate Vaccine (PCV13) Is Immunogenic and Safe in Children 6-17 Years of Age With Sickle Cell Disease Previously Vaccinated With 23-valent Pneumococcal Polysaccharide Vaccine (PPSV23): Results of a Phase 3 Study." Pediatric Blood & Cancer, vol. 62, no. 8, 2015, pp. 1427-36.
De Montalembert M, Abboud MR, Fiquet A, et al. 13-valent pneumococcal conjugate vaccine (PCV13) is immunogenic and safe in children 6-17 years of age with sickle cell disease previously vaccinated with 23-valent pneumococcal polysaccharide vaccine (PPSV23): Results of a phase 3 study. Pediatr Blood Cancer. 2015;62(8):1427-36.
De Montalembert, M., Abboud, M. R., Fiquet, A., Inati, A., Lebensburger, J. D., Kaddah, N., Mokhtar, G., Piga, A., Halasa, N., Inusa, B., Rees, D. C., Heath, P. T., Telfer, P., Driscoll, C., Al Hajjar, S., Tozzi, A., Jiang, Q., Emini, E. A., Gruber, W. C., ... Scott, D. A. (2015). 13-valent pneumococcal conjugate vaccine (PCV13) is immunogenic and safe in children 6-17 years of age with sickle cell disease previously vaccinated with 23-valent pneumococcal polysaccharide vaccine (PPSV23): Results of a phase 3 study. Pediatric Blood & Cancer, 62(8), 1427-36. https://doi.org/10.1002/pbc.25502
De Montalembert M, et al. 13-valent Pneumococcal Conjugate Vaccine (PCV13) Is Immunogenic and Safe in Children 6-17 Years of Age With Sickle Cell Disease Previously Vaccinated With 23-valent Pneumococcal Polysaccharide Vaccine (PPSV23): Results of a Phase 3 Study. Pediatr Blood Cancer. 2015;62(8):1427-36. PubMed PMID: 25810327.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 13-valent pneumococcal conjugate vaccine (PCV13) is immunogenic and safe in children 6-17 years of age with sickle cell disease previously vaccinated with 23-valent pneumococcal polysaccharide vaccine (PPSV23): Results of a phase 3 study. AU - De Montalembert,Mariane, AU - Abboud,Miguel R, AU - Fiquet,Anne, AU - Inati,Adlette, AU - Lebensburger,Jeffrey D, AU - Kaddah,Normeen, AU - Mokhtar,Galila, AU - Piga,Antonio, AU - Halasa,Natasha, AU - Inusa,Baba, AU - Rees,David C, AU - Heath,Paul T, AU - Telfer,Paul, AU - Driscoll,Catherine, AU - Al Hajjar,Sami, AU - Tozzi,Alberto, AU - Jiang,Qin, AU - Emini,Emilio A, AU - Gruber,William C, AU - Gurtman,Alejandra, AU - Scott,Daniel A, Y1 - 2015/03/23/ PY - 2014/09/09/received PY - 2015/02/10/accepted PY - 2015/3/27/entrez PY - 2015/3/27/pubmed PY - 2015/9/12/medline KW - 13-valent pneumococcal conjugate vaccine KW - 23-valent pneumococcal polysaccharide vaccine KW - hydroxycarbamide KW - immunogenicity KW - safety KW - sickle cell disease SP - 1427 EP - 36 JF - Pediatric blood & cancer JO - Pediatr Blood Cancer VL - 62 IS - 8 N2 - BACKGROUND: A large population of older children with sickle cell disease (SCD) is currently vaccinated with only 23-valent pneumococcal polysaccharide vaccine (PPSV23). In immunocompetent adults, PPSV23 vaccination reduces immune responses to subsequent vaccination with a pneumococcal vaccine. The 13-valent pneumococcal conjugate vaccine (PCV13), which addresses this limitation, may offer an advantage to this population at high risk of pneumococcal disease. PROCEDURE: Children with SCD 6-17 years of age previously vaccinated with PPSV23 at least 6 months before study enrollment received two doses of PCV13 6 months apart. Anti-pneumococcal polysaccharide immunoglobulin G (IgG) geometric mean concentrations (GMCs) and opsonophagocytic activity (OPA) geometric mean titers (GMTs) were measured before, 1 month after each administration, and 1 year after the second administration. RESULTS: Following each PCV13 administration, IgG GMCs and OPA GMTs significantly increased, and antibody levels after doses 1 and 2 were generally comparable. Antibody levels declined over the year following dose 2. At 1 year after the second administration, OPA GMTs for all and IgG GMCs for most serotypes remained above pre-vaccination levels. Most adverse events were due to vaso-occlusive crises, a characteristic of the underlying condition of SCD. CONCLUSIONS: Children with SCD who were previously vaccinated with PPSV23 responded well to 1 PCV13 dose, and a second dose did not increase antibody response. PCV13 antibodies persisted above pre-vaccination levels for all serotypes 1 year after dose 2. Children with SCD may benefit from at least one dose of PCV13. SN - 1545-5017 UR - https://www.unboundmedicine.com/medline/citation/25810327/13_valent_pneumococcal_conjugate_vaccine__PCV13__is_immunogenic_and_safe_in_children_6_17_years_of_age_with_sickle_cell_disease_previously_vaccinated_with_23_valent_pneumococcal_polysaccharide_vaccine__PPSV23_:_Results_of_a_phase_3_study_ DB - PRIME DP - Unbound Medicine ER -