title: Safety and immunogenicity of 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Nigerian children: Booster dose and 2-dose catch-up regimens in the second year of life.
abstract: In a previous study, 3-dose primary vaccination of Nigerian infants with the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) was immunogenic for vaccine pneumococcal serotypes, with comparable tolerability between PHiD-CV and control groups. In an open-label study (ClinicalTrials.gov, NCT01153893), 68 primed children received a PHiD-CV booster dose co-administered with a diphtheria-tetanus-acellular pertussis (DTPa) booster dose at 15-21 months and 36 children unprimed for pneumococcal vaccination received two PHiD-CV catch-up doses (first dose co-administered with DTPa booster dose) at 15-21 and 17-23 months. Adverse events were recorded and immune responses were measured before and one month after vaccination. In both groups, pain was the most frequent solicited local symptom and fever was the most frequent solicited general symptom after the booster dose and each catch-up dose. Few grade 3 solicited symptoms and no vaccine-related serious adverse events were reported. After booster vaccination, for each vaccine serotype, at least 98.5% of children had an antibody concentration ≥ 0.2 µg/ml and at least 94.0% had an opsonophagocytic activity (OPA) titer ≥ 8. After 2-dose catch-up, for each vaccine serotype, at least 97.1% had an antibody concentration ≥ 0.2 µg/ml, except for serotypes 6B (82.9%) and 23F (88.6%), and at least 91.4% had an OPA titer ≥8, except for serotypes 6B (77.4%) and 19F (85.3%). PHiD-CV induced antibody responses against protein D in both groups. In conclusion, PHiD-CV administered to Nigerian toddlers as a booster dose or 2-dose catch-up was well tolerated and immunogenic for vaccine pneumococcal serotypes and protein D.
authors.affiliation: Department of Community Health and Primary Health Care; Lagos State University College of Medicine; Ikeja, Lagos, Nigeria.
authors.forename: Olumuyiwa O
authors.initials: OO
authors.lastname: Odusanya
authors.affiliation: Department of Community Health and Primary Health Care; Lagos State University College of Medicine; Ikeja, Lagos, Nigeria.
authors.forename: Yetunde A
authors.initials: YA
authors.lastname: Kuyinu
authors.affiliation: Department of Paediatrics and Child Health; Lagos State University College of Medicine Ikeja; Ikeja, Lagos, Nigeria.
authors.forename: Omolara A
authors.initials: OA
authors.lastname: Kehinde
authors.affiliation: GlaxoSmithKline Pharmaceuticals; Bangalore, India.
authors.forename: Fakrudeen
authors.initials: F
authors.lastname: Shafi
authors.affiliation: GlaxoSmithKline Vaccines; Wavre, Belgium.
authors.forename: Nancy
authors.initials: N
authors.lastname: François
authors.affiliation: GlaxoSmithKline Vaccines; Wavre, Belgium.
authors.forename: Juan Pablo
authors.initials: JP
authors.lastname: Yarzabal
authors.affiliation: GlaxoSmithKline Vaccines; Wavre, Belgium.
authors.forename: Kurt
authors.initials: K
authors.lastname: Dobbelaere
authors.affiliation: GlaxoSmithKline Vaccines; Wavre, Belgium.
authors.forename: Jens U
authors.initials: JU
authors.lastname: Rüggeberg
authors.affiliation: GlaxoSmithKline Vaccines; Wavre, Belgium.
authors.forename: Dorota
authors.initials: D
authors.lastname: Borys
authors.affiliation: GlaxoSmithKline Vaccines; Wavre, Belgium.
authors.forename: Lode
authors.initials: L
authors.lastname: Schuerman
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood; D015331:Cohort Studies; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D005334:Fever / Q000139:chemically induced / Q000453:epidemiology; D006192:Haemophilus Infections / Q000517:prevention & control*; D006801:Humans; D007223:Infant; D008297:Male; D009549:Nigeria; D009895:Opsonin Proteins / Q000097:blood; D010146:Pain / Q000139:chemically induced / Q000453:epidemiology; D010587:Phagocytosis; D011008:Pneumococcal Infections / Q000517:prevention & control*; D022242:Pneumococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D014611:Vaccination / Q000009:adverse effects* / Q000379:methods*
chemical_list: D000907:Antibodies, Bacterial; D009895:Opsonin Proteins; C547294:PHiD-CV vaccine; D022242:Pneumococcal Vaccines
keywords: Nigeria; PHiD-CV; booster; catch-up; immunogenicity; pneumococcal conjugate vaccine; reactogenicity; safety