title: Safety, reactogenicity and immunogenicity of 2-dose catch-up vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Malian children in the second year of life: Results from an open study.
abstract: Pneumonia is still the leading cause of death among African children with pneumococcal serotypes 1 and 5 being dominant in the below 5 y of age group. The present study assessed the safety, reactogenicity and immunogenicity of a 2-dose catch-up vaccination with the 10-valent pneumococcal non-typeable Haemophilus influenzae Protein D conjugate vaccine (PHiD-CV) in Malian children. This phase III, open-label study (NCT00985465) was conducted in Ouelessebougou, Mali, between November 2009 and July 2010. The study population consisted of PHiD-CV unprimed Malian children previously enrolled in the control group of study NCT00678301 receiving a 2-dose catch-up vaccination with PHiD-CV in the second year of life. Adverse events were recorded following each PHiD-CV dose. Antibody responses and opsonophagocytic activity (OPA) were measured pre-vaccination and after the second PHiD-CV catch-up dose. Swelling and fever (axillary temperature ≥ 37.5°C) were the most frequently reported solicited symptoms following either PHiD-CV dose. Few grade 3 solicited symptoms were reported. Large swelling reactions and serious adverse events were not reported. Post-catch-up vaccination, for each vaccine pneumococcal serotype, at least 94.7% of subjects had antibody concentrations ≥ 0.2 μg/ml, except for serotypes 6B (82.5%) and 23F (87.7%). At least 94.0% of subjects had OPA titres ≥ 8, except for serotype 19F (89.4%). The geometric mean concentration for antibodies against protein D was 839.3 (95% CI: 643.5-1094.6) EL.U/ml. Two-dose PHiD-CV catch-up regimen in the second year of life was well-tolerated and immunogenic for all vaccine pneumococcal serotypes and NTHi protein D when administered to Malian children.
authors.affiliation: a Malaria Research and Training Center; Faculty of Medicine; Pharmacy and Dentistry; University of Bamako ; Bamako , Mali.
authors.forename: Alassane
authors.initials: A
authors.lastname: Dicko
authors.forename: Yahia
authors.initials: Y
authors.lastname: Dicko
authors.forename: Amadou
authors.initials: A
authors.lastname: Barry
authors.forename: Youssoufa
authors.initials: Y
authors.lastname: Sidibe
authors.forename: Almahamoudou
authors.initials: A
authors.lastname: Mahamar
authors.forename: Gaoussou
authors.initials: G
authors.lastname: Santara
authors.forename: Amagana
authors.initials: A
authors.lastname: Dolo
authors.forename: Aminata
authors.initials: A
authors.lastname: Diallo
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: Juan Pablo
authors.initials: JP
authors.lastname: Yarzabal
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; D001770:Blood Bactericidal Activity; D002675:Child, Preschool; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000473:pathology*; D004487:Edema / Q000139:chemically induced / Q000453:epidemiology / Q000473:pathology; D005260:Female; D005334:Fever / Q000139:chemically induced / Q000453:epidemiology / Q000473:pathology; D006801:Humans; D007223:Infant; D008297:Male; D008302:Mali; D009895:Opsonin Proteins / Q000097:blood; D022242:Pneumococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D011018:Pneumonia, Pneumococcal / Q000517:prevention & control*
chemical_list: D000907:Antibodies, Bacterial; D009895:Opsonin Proteins; C547294:PHiD-CV vaccine; D022242:Pneumococcal Vaccines
keywords: 22F-ELISA, 22F-inhibition enzyme-linked immunosorbent assay; 7vCRM, 7-valent pneumococcal CRM197 conjugate vaccine; AE, adverse event; ATP, according-to-protocol; CI, confidence interval; DTPw-HBV/Hib, diphtheria-tetanus-whole-cell pertussis, hepatitis B virus/Haemophilus influenzae type b vaccine; EL.U, ELISA unit; GAVI, Global Alliance for Vaccines and Immunization; GMC, geometric mean concentration; GMT, geometric mean titer; IPD, invasive pneumococcal disease; IgG, immunoglobulin G; LAR, legally acceptable representative; Mali; NTHi, non-typeable Haemophilus influenzae; OPA, opsonophagocytic activity; OPV, oral live attenuated poliovirus vaccine; PCV, pneumococcal conjugate vaccine; PHiD-CV; PHiD-CV, pneumococcal non-typeable Haemophilus influenzae (NTHi) protein D conjugate vaccine; SAE, serious adverse event; SD, standard deviation; catch-up vaccination; immunogenicity; pneumococcal conjugate vaccine; reactogenicity; safety