title: Primary vaccination with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in infants in Mali and Nigeria: a randomized controlled trial.
abstract: BACKGROUND
  Pneumonia is still the leading cause of death among children in Africa, and pneumococcal serotypes 1 and 5 are frequently isolated from African children with invasive pneumococcal disease below the age of 5 years. The immunogenicity, safety and reactogenicity of 3-dose primary vaccination with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) were evaluated in infants in Mali and Nigeria.
  
  
  METHODS
  In an open, randomized, controlled study, 357 infants received DTPw-HBV/Hib and OPV primary vaccination with (PHiD-CV group) or without (control group) PHiD-CV co-administration at 6, 10 and 14 weeks of age. Pneumococcal antibody responses and opsonophagocytic activity (OPA) were measured and adverse events (AEs) recorded.
  
  
  RESULTS
  One month post-dose 3, ≥ 97.2% of PHiD-CV-vaccinated infants had an antibody concentration ≥ 0.2 μg/mL for each vaccine pneumococcal serotype except for 6B (82.0%) and 23F (87.6%) versus < 10% in the control group except for serotypes 14 (35.7%) and 19F (22.5%). For each vaccine serotype, ≥ 93.3% of PHiD-CV recipients had an OPA titre ≥ 8, except for serotypes 1 (87.6%) and 6B (85.4%), compared to < 10% in the control group, except for serotypes 7F (42.9%), 9V (24.1%) and 14 (24.5%). Anti-protein D geometric mean antibody concentrations were 3791.8 and 85.4 EL.U/mL in the PHiD-CV and control groups, respectively. Overall incidences of solicited and unsolicited AEs were similar between groups.
  
  
  CONCLUSIONS
  In sub-Saharan African infants, PHiD-CV was immunogenic for all vaccine pneumococcal serotypes and protein D. Vaccine tolerability was generally comparable between the PHiD-CV and control groups.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT00678301.
authors: Malaria Research and Training Center, Faculty of Medicine, Pharmacy and Dentistry, University of Bamako, P,O, Box 1805, Bamako, Mali. adicko@mrtcbko.org
authors: Alassane
authors: A
authors: Dicko
authors: Olumuyiwa O
authors: OO
authors: Odusanya
authors: Abdoulbaki I
authors: AI
authors: Diallo
authors: Gaoussou
authors: G
authors: Santara
authors: Amadou
authors: A
authors: Barry
authors: Amagana
authors: A
authors: Dolo
authors: Aminata
authors: A
authors: Diallo
authors: Yetunde A
authors: YA
authors: Kuyinu
authors: Omolara A
authors: OA
authors: Kehinde
authors: Nancy
authors: N
authors: François
authors: Dorota
authors: D
authors: Borys
authors: Juan P
authors: JP
authors: Yarzabal
authors: Marta
authors: M
authors: Moreira
authors: Lode
authors: L
authors: Schuerman
mesh_terms: D017954:Africa South of the Sahara; D001426:Bacterial Proteins / Q000187:drug effects / Q000276:immunology*; D002352:Carrier Proteins / Q000187:drug effects / Q000276:immunology*; D005260:Female; D006192:Haemophilus Infections / Q000517:prevention & control*; D006193:Haemophilus influenzae / Q000187:drug effects / Q000276:immunology*; D006801:Humans; D007072:Immunoglobulin D / Q000187:drug effects / Q000276:immunology*; D007223:Infant; D008074:Lipoproteins / Q000187:drug effects / Q000276:immunology*; D008297:Male; D008302:Mali; D009549:Nigeria; D022242:Pneumococcal Vaccines / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D011322:Primary Prevention
chemical_list: C538863:10-valent pneumococcal vaccine; D001426:Bacterial Proteins; D002352:Carrier Proteins; D007072:Immunoglobulin D; D008074:Lipoproteins; D022242:Pneumococcal Vaccines; C067989:glpQ protein, Haemophilus influenzae