title: Safety, reactogenicity and immunogenicity of a booster dose of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Malian children.
abstract: BACKGROUND
  Primary vaccination with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) was previously shown to be immunogenic and well tolerated in Malian children. Data on booster vaccination with a fourth consecutive dose of PHiD-CV are available for Europe, Asia and Latin America but are lacking for Africa. The present study evaluated further the safety, reactogenicity and immunogenicity of a fourth consecutive (booster) dose of PHiD-CV.
  
  
  RESULTS
  Low incidences of AEs with grade 3 intensity (2.1% of subjects) were observed. There were no reports of large swelling reactions and serious adverse events. One month post-booster vaccination, for each vaccine pneumococcal serotype, at least 97.8% of subjects had antibody concentrations ≥ 0.2 μg/ml, and at least 97.1% of subjects had opsonophagocytic activity ≥ 8. From pre- to post-booster, a 12.3-fold increase in anti-protein D geometric mean concentration was observed.
  
  
  METHODS
  This phase III, open-label study was conducted in Ouelessebougou, Mali, between November 2009 and June 2010. The study population consisted of Malian children previously primed (3 doses) with PHiD-CV in study NCT00678301 receiving a fourth consecutive (booster) dose of PHiD-CV in the second year of life. The incidences of adverse events (AEs) with grade 3 intensity (primary objective) or of any intensity (secondary objective), and the immunogenicity (secondary objective) of the PHiD-CV booster dose were assessed.
  
  
  CONCLUSIONS
  A booster dose of PHiD-CV was well tolerated when administered to Malian children in the second year of life and was highly immunogenic for all 10 vaccine pneumococcal serotypes and NTHi protein D. (ClinicalTrials.gov identifier: NCT00985465).
authors.affiliation: Malaria Research and Training Centre; Faculty of Medicine; Pharmacy and Dentistry; University of Bamako; Bamako, Mali; Department of Public Health; Faculty of Medicine; Pharmacy and Dentistry; University of Bamako; Bamako, Mali.
authors.forename: Alassane
authors.initials: A
authors.lastname: Dicko
authors.forename: Gaoussou
authors.initials: G
authors.lastname: Santara
authors.forename: Almahamoudou
authors.initials: A
authors.lastname: Mahamar
authors.forename: Youssoufa
authors.initials: Y
authors.lastname: Sidibe
authors.forename: Amadou
authors.initials: A
authors.lastname: Barry
authors.forename: Yahia
authors.initials: Y
authors.lastname: Dicko
authors.forename: Aminata
authors.initials: A
authors.lastname: Diallo
authors.forename: Amagana
authors.initials: A
authors.lastname: Dolo
authors.forename: Ogobara
authors.initials: O
authors.lastname: Doumbo
authors.forename: Fakrudeen
authors.initials: F
authors.lastname: Shafi
authors.forename: Nancy
authors.initials: N
authors.lastname: François
authors.forename: Ana
authors.initials: A
authors.lastname: Strezova
authors.forename: Dorota
authors.initials: D
authors.lastname: Borys
authors.forename: Lode
authors.initials: L
authors.lastname: Schuerman
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D006192:Haemophilus Infections / Q000517:prevention & control*; D006801:Humans; D007117:Immunization, Secondary / Q000009:adverse effects* / Q000379:methods*; D015994:Incidence; D007223:Infant; D008297:Male; D008302:Mali; D009895:Opsonin Proteins / Q000097:blood; D010587:Phagocytosis; D022242:Pneumococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*
chemical_list: C586648:10-valent pneumococcal conjugate vaccine; D000907:Antibodies, Bacterial; D009895:Opsonin Proteins; C547294:PHiD-CV vaccine; D022242:Pneumococcal Vaccines
keywords: Mali; PHiD-CV; antibody persistence; booster; immunogenicity; pneumococcal conjugate vaccine; reactogenicity; safety