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Efficacy,safety and immunogenicity of a pneumococcal protein-based vaccine co-administered with 13-valent pneumococcal conjugate vaccine against acute otitis media in young children: A phase IIb randomized study
Affiliation:1. Center for American Indian Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States;2. GSK, Wavre, Belgium;3. XPE Pharma & Science c/o GSK, Wavre, Belgium
Abstract:BackgroundNative American populations experience a substantial burden of pneumococcal disease despite use of highly effective pneumococcal conjugate vaccines (PCVs). Protein-based pneumococcal vaccines may extend protection beyond the serotype-specific protection elicited by PCVs.MethodsIn this phase IIb, double-blind, controlled trial, 6–12 weeks-old Native American infants randomized 1:1, received either a protein-based pneumococcal vaccine (dPly/PhtD) containing pneumolysin toxoid (dPly, 10 µg) and pneumococcal histidine triad protein D (PhtD, 10 µg) or placebo, administered along with 13-valent PCV (PCV13) at ages 2, 4, 6 and 12–15 months. Other pediatric vaccines were given per the routine immunization schedule. We assessed vaccine efficacy (VE) against acute otitis media (AOM) and acute lower respiratory tract infection (ALRI) endpoints. Immunogenicity, reactogenicity and unsolicited adverse events were assessed in a sub-cohort and serious adverse events were assessed in all children.Results1803 infants were randomized (900 dPly/PhtD; 903 Control). VE against all episodes of American Academy of Pediatrics (AAP)-defined AOM was 3.8% (95% confidence interval: −11.4, 16.9). Point estimates of VE against other AOM outcomes ranged between 2.9% (−9.5, 14.0) and 5.2% (−8.0, 16.8). Point estimates of VE against ALRI outcomes ranged between −4.4% (−39.2, 21.8) and 2.0% (−18.3, 18.8). Point estimates of VE tended to be higher against first than all episodes but the confidence intervals included zero. dPly/PhtD vaccine was immunogenic and had an acceptable reactogenicity and safety profile after primary and booster vaccination in Native American infants.ConclusionsThe dPly/PhtD vaccine was immunogenic and well tolerated, however, incremental efficacy in preventing AAP-AOM over PCV13 was not demonstrated.Clinical trials registrationNCT01545375 (www.clinicaltrials.gov)
Keywords:Immunogenicity  Reactogenicity  Acute otitis media  Vaccines  Native American  AAP"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  k0040"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  American Academy of Pediatrics  ABS"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  k0050"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  active bacterial surveillance  AE"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  k0060"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  adverse event  ALRI"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  k0070"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  acute lower respiratory tract infection  AOM"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  k0080"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  acute otitis media  ATP"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  k0090"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  according-to-protocol  CI"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  k0100"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  confidence interval  dPly"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  k0110"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  pneumolysin toxoid  ELISA"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  k0120"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  enzyme linked immunosorbent assay  EL.U"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  k0130"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  ELISA units  GMC"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  k0140"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  geometric mean concentration  HCP"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  k0150"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  health-care provider  IHS"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  ce.keyword_xdt_lpx_fjb"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  Indian Health Service  IPD"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  k0160"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  invasive pneumococcal disease  LLOQ"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  k0170"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  lower limit of quantification  MA"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  k0180"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  medically-attended  mATP"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  k0190"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  modified according-to-protocol  PCV"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  k0200"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  pneumococcal conjugate vaccine  PCV13"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  k0210"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  13-valent pneumococcal conjugate vaccine  PHiD-CV"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  k0220"  },"  $$"  :[{"  #name"  :"  text"  ,"  $$"  :[{"  #name"  :"  __text__"  ,"  _"  :"  pneumococcal non-typeable "  },{"  #name"  :"  italic"  ,"  _"  :"  Haemophilus influenzae"  },{"  #name"  :"  __text__"  ,"  _"  :"   protein D conjugate vaccine  PhtD"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  k0230"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  pneumococcal histidine triad protein D  Ply"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  k0240"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  pneumolysin  SAE"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  k0250"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  serious adverse event  SAS"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  k0260"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  Statistical Analysis System  TVC"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  k0270"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  total vaccinated cohort  ULOQ"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  k0280"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  upper limit of quantification  VE"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  k0290"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  vaccine efficacy
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