title: Immunogenicity and Safety of 10-valent Pneumococcal Nontypeable Haemophilus influenzae Protein D Conjugate Vaccine (PHiD-CV) Administered to Children With Sickle Cell Disease Between 8 Weeks and 2 Years of Age: A Phase III, Open, Controlled Study.
abstract: BACKGROUND
  Immunogenicity, safety and reactogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) were evaluated in children with sickle cell disease (SCD), who are at increased risk for infections.
  
  
  METHODS
  In this phase III, open-label, single-center, controlled study in Burkina Faso (NCT01175083), children with SCD (S) or without SCD (NS) were assigned to 6 groups (N = 300): children 8-11 weeks of age (<6 months; <6S and <6NS groups) received 3 primary doses and a booster dose of PHiD-CV coadministered with routine childhood vaccines; children 7-11 months of age (7-11S and 7-11NS groups) received 2 primary doses and a booster dose of PHiD-CV; children 12-23 months of age (12-23S and 12-23NS groups) received 2 catch-up doses of PHiD-CV. Pneumococcal antibody responses were measured using 22F-inhibition enzyme-linked immunosorbent assay and functional opsonophagocytic activity. Responses to other antigens were measured by enzyme-linked immunosorbent assay. Adverse events were recorded.
  
  
  RESULTS
  One month postprimary vaccination, for each vaccine serotype ≥98% of infants in the <6S and <6NS groups had antibody concentrations ≥0.2 µg/mL, except for 6B (≥85%) and 23F (≥89%). Immune responses to PHiD-CV after age-appropriate vaccination in children <2 years did not appear influenced by SCD. All infants were seroprotected/seropositive for diphtheria, tetanus and Bordetella pertussis antigens postprimary and booster vaccination. Safety and reactogenicity profiles were similar in children with or without SCD.
  
  
  CONCLUSIONS
  PHiD-CV was immunogenic with an acceptable safety profile in children with and without SCD starting vaccination at 8 weeks to 23 months of age.
authors.affiliation: From the *Groupe de Recherche Action en Santé (GRAS), Ouagadougou, Burkina Faso; †Centre National de Recherche et de Formation sur le Paludisme (CNRFP), Ouagadougou, Burkina Faso; ‡Centre Hospitalier Universitaire Yalgado Ouédraogo (CHUYO), Ouagadougou, Burkina Faso; §GSK, Wavre, Belgium; and ¶XPE Pharma & Science C/O GSK, Wavre, Belgium.
authors.forename: Sodiomon B
authors.initials: SB
authors.lastname: Sirima
authors.forename: Alfred
authors.initials: A
authors.lastname: Tiono
authors.forename: Zakaria
authors.initials: Z
authors.lastname: Gansané
authors.forename: Mohamadou
authors.initials: M
authors.lastname: Siribié
authors.forename: Angèle
authors.initials: A
authors.lastname: Zongo
authors.forename: Alphonse
authors.initials: A
authors.lastname: Ouédraogo
authors.forename: Nancy
authors.initials: N
authors.lastname: François
authors.forename: Ana
authors.initials: A
authors.lastname: Strezova
authors.forename: Kurt
authors.initials: K
authors.lastname: Dobbelaere
authors.forename: Dorota
authors.initials: D
authors.lastname: Borys
mesh_terms: D000367:Age Factors; D000755:Anemia, Sickle Cell / Q000276:immunology* / Q000473:pathology; D000907:Antibodies, Bacterial / Q000096:biosynthesis*; D001426:Bacterial Proteins / Q000737:chemistry / Q000276:immunology; D002352:Carrier Proteins / Q000737:chemistry / Q000276:immunology; D002675:Child, Preschool; D004334:Drug Administration Schedule; D005260:Female; D006192:Haemophilus Infections / Q000276:immunology / Q000473:pathology / Q000517:prevention & control*; D006193:Haemophilus influenzae; D006801:Humans; D007117:Immunization, Secondary; D000071497:Immunogenicity, Vaccine; D007072:Immunoglobulin D / Q000737:chemistry / Q000276:immunology; D007223:Infant; D008074:Lipoproteins / Q000737:chemistry / Q000276:immunology; D008297:Male; D061214:Patient Safety; D022242:Pneumococcal Vaccines / Q000008:administration & dosage* / Q000096:biosynthesis / Q000276:immunology; D014611:Vaccination; D018074:Vaccines, Conjugate; D022223:Vaccines, Subunit
chemical_list: D000907:Antibodies, Bacterial; D001426:Bacterial Proteins; D002352:Carrier Proteins; D007072:Immunoglobulin D; D008074:Lipoproteins; D022242:Pneumococcal Vaccines; D018074:Vaccines, Conjugate; D022223:Vaccines, Subunit; C067989:glpQ protein, Haemophilus influenzae