Immunogenicity and safety of concomitant administration of meningococcal serogroup B (4CMenB) and serogroup C (MenC-CRM) vaccines in infants: A phase 3b, randomized controlled trial

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.

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“…These results were consistent with what was observed in studies with infants of similar age. 17 , 18 …”

Section: Discussionmentioning

confidence: 99%

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

Chiu

Huang

Willemsen³

et al. 2018

Human Vaccines & Immunotherapeutics

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“…4CMenB may be co-administered with diphtheria, tetanus, acellular pertussis, Haemophilus influenzae type b, inactivated poliomyelitis, hepatitis B, heptavalent pneumococcal conjugate, meningococcal C conjugate, rotavirus, measles, mumps, rubella, and varicella vaccines [72]. The available data suggested that the overall responses to 4CMenB and the coadministered vaccines were not impacted by concomitant administration [6,[66][67][68][69]73].…”

Section: Evidence Supporting 4cmenb Vaccination In Infantsmentioning

confidence: 99%

Meningococcal B vaccine (4CMenB): the journey from research to real world experience

Rappuoli

Pizza

Masignani³

et al. 2018

Expert Review of Vaccines

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Introduction: Neisseria meningitidis serogroup B (MenB) is the most common cause of bacterial meningitis in many industrialized countries and occurs at any age. The highest incidence is in infants aged <1 year, followed by children and adolescents. Four-component MenB vaccine (4CMenB, Bexsero) is the only MenB vaccine authorized for use in all age-groups. Experience with 4CMenB is growing as it is implemented in different countries/age-groups encompassing university students, children, adolescents, and infant mass vaccination programs. Areas covered: An update of recently available data describing the mechanism of immunogenicity of 4CMenB and real-world evidence of vaccine effectiveness and disease impact. We discuss the appropriate age for vaccination to maximize population impacts. Expert commentary: Invasive meningococcal disease is uncommon and sufficiently powered efficacy studies were not feasible during 4CMenB development. Additionally, several thousand genetically diverse invasive MenB strains circulate globally, varying widely in surface protein expression. This posed significant challenges in predicting clinical protection with MenB vaccines. Five years of 4CMenB use post-licensure confirm the clinical benefit of vaccination as predicted during development. Preliminary evidence suggests an extended impact on other meningococcal serogroups and Neisseria gonorrhoeae.

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“…No entanto, esquemas de vacinação com duas doses e reforço aos 11-12 meses, semelhantes ao adotado no Reino Unido, mostraram ser igualmente imunogénicos. 20,21 Sendo a febre um efeito secundário frequente, em particular quando a Bexsero® é dada em simultâneo com outras vacinas, recomenda-se a administração de paracetamol, no momento da vacinação ou pouco tempo depois, podendo ser administradas mais duas tomas com intervalos de 4-6 horas, o que reduzirá a febre, não havendo evidência de interferência com significado na resposta imunitária. 22…”

Section: Vacinas Contra N Meningitidis Do Grupo Bunclassified

Recomendações Sobre a Vacina Contra Neisseria meningitidis

Moreira¹

2018

Acta Pediátrica Port

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This paper on vaccination against Neisseria meningitidis is the first of a series of five on the recommendations of the Vaccine Committee of the Society of Paediatric Infectious Diseases and the Portuguese Society of Paediatrics, updated in 2018, for vaccines not included in the Portuguese national immunisation programme. The other four papers, also to be published in Acta Pediátrica Portuguesa, discuss the recommendations for vaccination against human papillomavirus in males, rotavirus, varicella and hepatitis A virus.

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Immunogenicity and safety of concomitant administration of meningococcal serogroup B (4CMenB) and serogroup C (MenC-CRM) vaccines in infants: A phase 3b, randomized controlled trial

Cited by 16 publications

References 24 publications

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

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

Meningococcal B vaccine (4CMenB): the journey from research to real world experience

Recomendações Sobre a Vacina Contra Neisseria meningitidis

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