title: A novel combined Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y-tetanus-toxoid conjugate vaccine is immunogenic and induces immune memory when co-administered with DTPa-HBV-IPV and conjugate pneumococcal vaccines in infants.
abstract: Immunogenicity and safety of a novel combined Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y-tetanus-toxoid conjugate vaccine (Hib-MenCY-TT) candidate was evaluated when co-administered with DTPa-HBV-IPV(Pediarix)+PCV7(Prevnar) at 2-4-6 months of age. Anti-PRP concentrations >or= 1.0 microg/mL were observed in 92.9-98.7%, rSBA-MenC/Y titres >or= 1:8 in >98%, rSBA-MenC/Y titres >or= 1:128 in >95.8 and >89.9% subjects. PRP and MenC responses were similar to respective controls (ActHIB and Menjugate) including for antibody persistence. Response to co-administered vaccines was not impaired. Polysaccharide challenge (PRP, PSC, PSY at 11-14 months of age) evidenced immune memory was induced for Hib, MenC/Y conjugate components. The safety profile of Hib-MenCY-TT was similar to controls. Hib-MenCY-TT administered according to the current US Hib vaccine schedule has the potential to induce protective antibodies against Hib and meningococcal-CY disease in infants and toddlers.
authors.affiliation: Murdoch Children's Research Institute and School of Population Health, The University of Melbourne, Australia. t.nolan@unimelb.edu.au
authors.forename: Terry
authors.initials: T
authors.lastname: Nolan
authors.forename: Stephen
authors.initials: S
authors.lastname: Lambert
authors.forename: Don
authors.initials: D
authors.lastname: Roberton
authors.forename: Helen
authors.initials: H
authors.lastname: Marshall
authors.forename: Peter
authors.initials: P
authors.lastname: Richmond
authors.forename: Catherine
authors.initials: C
authors.lastname: Streeton
authors.forename: Jan
authors.initials: J
authors.lastname: Poolman
authors.forename: Dominique
authors.initials: D
authors.lastname: Boutriau
mesh_terms: D000907:Antibodies, Bacterial / Q000032:analysis / Q000096:biosynthesis; D001428:Bacterial Vaccines / Q000009:adverse effects / Q000276:immunology*; D001770:Blood Bactericidal Activity; D003165:Complement System Proteins / Q000032:analysis / Q000096:biosynthesis; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D018073:Haemophilus Vaccines / Q000009:adverse effects / Q000276:immunology*; D019741:Haemophilus influenzae type b / Q000276:immunology*; D017325:Hepatitis B Vaccines; D006801:Humans; D007156:Immunologic Memory / Q000187:drug effects; D007223:Infant; D008297:Male; D038542:Neisseria meningitidis, Serogroup C / Q000276:immunology*; D038581:Neisseria meningitidis, Serogroup Y / Q000276:immunology*; D011054:Poliovirus Vaccine, Inactivated; D013745:Tetanus Toxoid / Q000009:adverse effects / Q000276:immunology*; D017778:Vaccines, Combined / Q000276:immunology*; D018074:Vaccines, Conjugate / Q000009:adverse effects / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D001428:Bacterial Vaccines; C451839:DTPa-HBV-IPV combined vaccine; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; D017325:Hepatitis B Vaccines; C527605:Hib-MenCY-TT vaccine; D011054:Poliovirus Vaccine, Inactivated; D013745:Tetanus Toxoid; D017778:Vaccines, Combined; D018074:Vaccines, Conjugate; D003165:Complement System Proteins