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

Terry Nolan; Stephen Lambert; Don Roberton; Helen Marshall; Peter Richmond; Catherine Streeton; Jan Poolman; Dominique Boutriau

doi:10.1016/j.vaccine.2007.10.013

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

Vaccine. 2007 Dec 12;25(51):8487-99. doi: 10.1016/j.vaccine.2007.10.013. Epub 2007 Oct 25.

Authors

Terry Nolan¹, Stephen Lambert, Don Roberton, Helen Marshall, Peter Richmond, Catherine Streeton, Jan Poolman, Dominique Boutriau

Affiliation

¹ Murdoch Children's Research Institute and School of Population Health, The University of Melbourne, Australia. t.nolan@unimelb.edu.au

PMID: 17996996
DOI: 10.1016/j.vaccine.2007.10.013

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.

Trial registration: ClinicalTrials.gov NCT00127855.

Publication types

Randomized Controlled Trial

MeSH terms

Antibodies, Bacterial / analysis
Antibodies, Bacterial / biosynthesis
Bacterial Vaccines / adverse effects
Bacterial Vaccines / immunology*
Blood Bactericidal Activity
Complement System Proteins / analysis
Complement System Proteins / biosynthesis
Diphtheria-Tetanus-Pertussis Vaccine
Enzyme-Linked Immunosorbent Assay
Female
Haemophilus Vaccines / adverse effects
Haemophilus Vaccines / immunology*
Haemophilus influenzae type b / immunology*
Hepatitis B Vaccines
Humans
Immunologic Memory / drug effects
Infant
Male
Neisseria meningitidis, Serogroup C / immunology*
Neisseria meningitidis, Serogroup Y / immunology*
Poliovirus Vaccine, Inactivated
Tetanus Toxoid / adverse effects
Tetanus Toxoid / immunology*
Vaccines, Combined / immunology*
Vaccines, Conjugate / adverse effects
Vaccines, Conjugate / immunology

Substances

Antibodies, Bacterial
Bacterial Vaccines
DTPa-HBV-IPV combined vaccine
Diphtheria-Tetanus-Pertussis Vaccine
Haemophilus Vaccines
Hepatitis B Vaccines
Hib-MenCY-TT vaccine
Poliovirus Vaccine, Inactivated
Tetanus Toxoid
Vaccines, Combined
Vaccines, Conjugate
Complement System Proteins

Associated data

ClinicalTrials.gov/NCT00127855