title: Immunogenicity, safety and reactogenicity of the 10-valent pneumococcal non-typeable haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Nigerian Infants: a randomised trial.
abstract: OBJECTIVE
  The immunogenicity, reactogenicity and safety of the 10- valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) were evaluated in a cohort of Nigerian infants included in a study conducted in Mali and Nigeria (ClinicalTrials.gov identifier: NCT00678301).
  
  
  METHODS
  In this open, randomised, controlled study, 119 healthy infants received combined diphtheria-tetanus-whole-cell pertussis-hepatitis B/ Haemophilus influenzae type b vaccine (DTPw-HBV/Hib) and oral poliovirus vaccine (OPV) co-administered with PHiD-CV (PHiD-CV group) or without PHiD-CV (control group) at 6-10-14 weeks of age. Pneumococcal antibody responses and opsonophagocytic activity were measured and adverse events were recorded.
  
  
  RESULTS
  One month post-dose 3, for each of the vaccine pneumococcal serotypes, e"90.1% of PHiD-CV recipients had an antibody concentration e"0.2 ug/mL compared to < 9 % (except for serotypes 14 [32.4%] and 19F [27.8%]) in the control group. For each of the vaccine pneumococcal serotypes, e"90.6% of infants in the PHiD-CV group had an OPA titre e"8, compared to % 18% (except for serotype 7F [60.0%]) in the control group. Anti-protein D antibody geometric mean antibody concentrations were 2949.7 EL.U/mL in the PHiD-CV group and 68.9 EL.U/mL in the control group. For each DTPw-HBV/Hib antigen antibody seroprotection/seropositivity rates were e"94.4%. Tolerability was generally comparable between the PHiD-CV and control vaccination groups.
  
  
  CONCLUSIONS
  PHiD-CV co-administered with routine vaccines was immunogenic for all vaccine pneumococcal serotypes and protein D in Nigerian infants. Vaccine tolerability was generally comparable between the PHiD-CV and control groups. These results suggest PHiD-CV can be co-administered with other vaccines included in the National Programme on Immunisation.
authors.affiliation: Department of Community Health and Primary Health Care, Lagos State University College of Medicine, P M B 21266 Ikeja, Lagos, Nigeria. oolumuiwa@yahoo.com
authors.forename: O O
authors.initials: OO
authors.lastname: Odusanya
authors.forename: Y A
authors.initials: YA
authors.lastname: Kuyinu
authors.forename: O A
authors.initials: OA
authors.lastname: Kehinde
authors.forename: N
authors.initials: N
authors.lastname: Francois
authors.forename: J P
authors.initials: JP
authors.lastname: Yarzabal
authors.forename: M
authors.initials: M
authors.lastname: Moreira
authors.forename: D
authors.initials: D
authors.lastname: Borys
authors.forename: L
authors.initials: L
authors.lastname: Schuerman
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood*; D001426:Bacterial Proteins / Q000276:immunology*; D001886:Bordetella pertussis / Q000276:immunology; D002352:Carrier Proteins / Q000276:immunology*; D015331:Cohort Studies; D004167:Diphtheria Toxin / Q000276:immunology; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage; D005260:Female; D018073:Haemophilus Vaccines / Q000008:administration & dosage; D006514:Hepatitis B Surface Antigens / Q000276:immunology; D017325:Hepatitis B Vaccines / Q000008:administration & dosage; D006801:Humans; D007072:Immunoglobulin D / Q000276:immunology*; D007074:Immunoglobulin G / Q000097:blood; D007223:Infant; D008074:Lipoproteins / Q000276:immunology*; D008297:Male; D009549:Nigeria; D022242:Pneumococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D011055:Poliovirus Vaccine, Oral / Q000008:administration & dosage; D011134:Polysaccharides / Q000276:immunology; D013296:Streptococcus pneumoniae / Q000276:immunology*; D013744:Tetanus Toxin / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D001426:Bacterial Proteins; D002352:Carrier Proteins; D004167:Diphtheria Toxin; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D007072:Immunoglobulin D; D007074:Immunoglobulin G; D008074:Lipoproteins; C547294:PHiD-CV vaccine; D022242:Pneumococcal Vaccines; D011055:Poliovirus Vaccine, Oral; D011134:Polysaccharides; D013744:Tetanus Toxin; C080881:diphtheria-tetanus-pertussis-haemophilus b conjugate vaccine; C008984:polyribitol phosphate; C067989:glpQ protein, Haemophilus influenzae