Safety and immunogenicity of a meningococcal B recombinant vaccine when administered with routine vaccines to healthy infants in Taiwan: A phase 3, open-label, randomized study
Journal
Human Vaccines and Immunotherapeutics
Journal Volume
14
Journal Issue
5
Pages
1075-1083
Date Issued
2018
Author(s)
Abstract
Neisseria meningitidis is associated with high mortality and morbidity in infants and children worldwide. This phase 3 study (NCT02173704) evaluated safety and immunogenicity of a 4-component serogroup B recombinant meningococcal vaccine (4CMenB) co-administered with routine vaccines in Taiwanese infants. In total, 225 healthy infants were randomized (2 : 1) to receive 4CMenB and routine vaccines (4CMenB+Routine) or routine vaccines only (Routine group) at 2, 4, 6 and 12?months of age. Routine vaccines were diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae type b, 13-valent pneumococcal, hepatitis B, measles-mumps-rubella and varicella vaccines. Immune responses to 4CMenB components (factor H binding protein [fHbp], Neisserial adhesin A [NadA], porin A [PorA] and Neisseria heparin-binding antigen [NHBA]) were evaluated at 1 month post-primary and post-booster vaccination, using human serum bactericidal assay (hSBA). Reactogenicity and safety were also assessed. A sufficient immune response was demonstrated for fHbp, NadA and PorA, at 1?month post-primary and booster vaccination. In the 4CMenB+Routine group, hSBA titers ?5 were observed in all infants for fHbp and NadA, in 79% and 59% of infants for PorA and NHBA, respectively, at 1?month post-primary vaccination and in 92–99% of infants for all antigens, at 1?month post-booster vaccination. In the 4CMenB+Routine group, hSBA geometric mean titers for all antigens increased post-primary (8.41–963) and post-booster vaccination (17–2315) compared to baseline (1.01–1.36). Immunogenicity of 4CMenB was not impacted by co-administration with routine pediatric vaccines in infants. Reactogenicity was slightly higher in the 4CMenB+Routine group compared with Routine group, but no safety concerns were identified. ? 2018 GlaxoSmithKline Biologicals SA. Published with license by Taylor & Francis ? 2018, ? GlaxoSmithKline Biologicals SA.
Subjects
co-administration; immunogenicity; infant; Neisseria meningitidis; safety; serogroup B meningococcal vaccine
Other Subjects
chickenpox measles mumps rubella vaccine; diphtheria pertussis poliomyelitis tetanus vaccine; Haemophilus influenzae type b vaccine; hepatitis B vaccine; measles mumps rubella vaccine; Meningococcus vaccine; Pneumococcus vaccine; recombinant hepatitis B vaccine; varicella zoster vaccine; 4CMenB vaccine; bacterium antibody; Meningococcus vaccine; recombinant vaccine; Article; bacterial strain; bactericidal activity; clinical assessment; controlled study; drug safety; drug tolerability; human; immune response; immunization; infant; lymphadenopathy; meningococcosis; Neisseria meningitidis; phase 3 clinical trial; randomized controlled trial; Taiwan; vaccination; vaccine immunogenicity; clinical trial; female; immunology; incidence; male; meningococcosis; microbiology; Neisseria meningitidis; procedures; secondary immunization; serum bactericidal antibody assay; Antibodies, Bacterial; Female; Humans; Immunization Schedule; Immunization, Secondary; Immunogenicity, Vaccine; Incidence; Infant; Male; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis, Serogroup B; Serum Bactericidal Antibody Assay; Taiwan; Vaccination; Vaccines, Synthetic
Publisher
Taylor and Francis Inc.
Type
journal article