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

Mariane De Montalembert, Miguel R. Abboud, Anne Fiquet, Adlette Inati, Jeffrey D. Lebensburger, Normeen Kaddah, Galila Mokhtar, Antonio Piga, Natasha Halasa, Baba Inusa, David C. Rees, Paul T. Heath, Paul Telfer, Catherine Driscoll, Sami Al Hajjar, Alberto Tozzi, Qin Jiang, Emilio A. Emini, William C. Gruber, Alejandra GurtmanDaniel A. Scott

Research output: Contribution to journalArticle

17 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1427-1436
Number of pages10
JournalPediatric Blood and Cancer
Volume62
Issue number8
DOIs
StatePublished - Aug 1 2015

Fingerprint

Conjugate Vaccines
Pneumococcal Vaccines
Sickle Cell Anemia
Vaccination
Immunoglobulin G
Antibodies
Antibody Formation
Polysaccharides
Pneumovax 23
13-valent pneumococcal vaccine
Population

Keywords

  • 13-valent pneumococcal conjugate vaccine
  • 23-valent pneumococcal polysaccharide vaccine
  • Hydroxycarbamide
  • Immunogenicity
  • Safety
  • Sickle cell disease

ASJC Scopus subject areas

  • Oncology
  • Pediatrics, Perinatology, and Child Health
  • Hematology
  • Medicine(all)

Cite this

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. / De Montalembert, Mariane; Abboud, Miguel R.; Fiquet, Anne; Inati, Adlette; Lebensburger, Jeffrey D.; Kaddah, Normeen; Mokhtar, Galila; Piga, Antonio; Halasa, Natasha; Inusa, Baba; Rees, David C.; Heath, Paul T.; Telfer, Paul; Driscoll, Catherine; Al Hajjar, Sami; Tozzi, Alberto; Jiang, Qin; Emini, Emilio A.; Gruber, William C.; Gurtman, Alejandra; Scott, Daniel A.

In: Pediatric Blood and Cancer, Vol. 62, No. 8, 01.08.2015, p. 1427-1436.

Research output: Contribution to journalArticle

De Montalembert, M, Abboud, MR, Fiquet, A, Inati, A, Lebensburger, JD, Kaddah, N, Mokhtar, G, Piga, A, Halasa, N, Inusa, B, Rees, DC, Heath, PT, Telfer, P, Driscoll, C, Al Hajjar, S, Tozzi, A, Jiang, Q, Emini, EA, Gruber, WC, Gurtman, A & Scott, DA 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 and Cancer, vol. 62, no. 8, pp. 1427-1436. https://doi.org/10.1002/pbc.25502
De Montalembert, Mariane ; Abboud, Miguel R. ; Fiquet, Anne ; Inati, Adlette ; Lebensburger, Jeffrey D. ; Kaddah, Normeen ; Mokhtar, Galila ; Piga, Antonio ; Halasa, Natasha ; Inusa, Baba ; Rees, David C. ; Heath, Paul T. ; Telfer, Paul ; Driscoll, Catherine ; Al Hajjar, Sami ; Tozzi, Alberto ; Jiang, Qin ; Emini, Emilio A. ; Gruber, William C. ; Gurtman, Alejandra ; Scott, Daniel A. / 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. In: Pediatric Blood and Cancer. 2015 ; Vol. 62, No. 8. pp. 1427-1436.
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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.",
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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)

T2 - 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.

PY - 2015/8/1

Y1 - 2015/8/1

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.

AB - 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.

KW - 13-valent pneumococcal conjugate vaccine

KW - 23-valent pneumococcal polysaccharide vaccine

KW - Hydroxycarbamide

KW - Immunogenicity

KW - Safety

KW - Sickle cell disease

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