Safety of meningococcal group B vaccination in hospitalised premature infants

Kent, Alison; Beebeejaun, Kazim; Braccio, Serena; Kadambari, Seilesh; Clarke, Paul; Heath, Paul T; Ladhani, Shamez

doi:10.1136/archdischild-2017-314152

Cited by 15 publications

(8 citation statements)

References 13 publications

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“…Importantly, an elevated CRP (> 5mg/l) was common 24 h post-vaccination-CRP levels and neutrophil counts are commonly used as diagnostic markers in suspected sepsis-these findings need to be taken into consideration when assessing febrile infants following vaccination (Van den Bruel et al, 2011; Faix, 2013). These data are consistent with a recent report showing increased CRP levels from 12 to 72 h post-vaccination, in premature infants administered 4CMenB with routine vaccines (Kent et al, 2019).…”

Section: Discussionsupporting

confidence: 93%

Gene expression profiling reveals insights into infant immunological and febrile responses to group B meningococcal vaccine

O’Connor

Pinto

Sheerin

et al. 2020

Molecular Systems Biology

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Neisseria meningitidis is a major cause of meningitis and septicaemia. A MenB vaccine (4CMenB) was licensed by the European Medicines Agency in January 2013. Here we describe the blood transcriptome and proteome following infant immunisations with or without concomitant 4CMenB, to gain insight into the molecular mechanisms underlying post-vaccination reactogenicity and immunogenicity. Infants were randomised to receive control immunisations (PCV13 and DTaP-IPV-Hib) with or without 4CMenB at 2 and 4 months of age. Blood gene expression and plasma proteins were measured prior to, then 4 h, 24 h, 3 days or 7 days post-vaccination. 4CMenB vaccination was associated with increased expression of ENTPD7 and increased concentrations of 4 plasma proteins: CRP, G-CSF, IL-1RA and IL-6. Post-vaccination fever was associated with increased expression of SELL, involved in neutrophil recruitment. A murine model dissecting the vaccine components found the concomitant regimen to be associated with increased gene perturbation compared with 4CMenB vaccine alone with enhancement of pathways such as interleukin-3,-5 and GM-CSF signalling. Finally, we present transcriptomic profiles predictive of immunological and febrile responses following 4CMenB vaccine.

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Section: Discussionsupporting

confidence: 93%

Gene expression profiling reveals insights into infant immunological and febrile responses to group B meningococcal vaccine

O’Connor

Pinto

Sheerin

et al. 2020

Molecular Systems Biology

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“…16,[18][19][20]22 As of December 2019, no major safety concerns had been identified after more than 3 million doses had been administered to infants, 23 older children and adolescents, 24,25 and premature infants. 26 Unlike the polysaccharide-protein conjugate vaccines, however, 4CMenB does not have any effect on menin-gococcal group B carriage in immunized adolescents; therefore, immunization strategies with 4CMenB will need to focus on direct (individual) protection against meningococcal group B disease. 27 In conclusion, 3 years after its implementation, 4CMenB continued to protect infants and toddlers against invasive meningococcal group B disease.…”

Section: Discussionmentioning

confidence: 99%

Vaccination of Infants with Meningococcal Group B Vaccine (4CMenB) in England

et al. 2020

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, the United Kingdom introduced the multicomponent meningococcal group B vaccine (4CMenB, Bexsero) into its publicly funded national immunization program at a reduced two-dose priming schedule for infants, with a 12-month booster. METHODS Using data from enhanced national surveillance of invasive meningococcal disease in England, we evaluated the effect of vaccination on the incidence of meningococcal group B disease during the first 3 years of the program. The effect of vaccination was assessed by comparing the observed incidence of disease with the expected incidence based on the incidence during the 4-year prevaccination period in equivalent cohorts and with the use of disease trends in cohorts of children younger than 5 years of age who were not eligible to receive the vaccine. Vaccine effectiveness was estimated with the use of the indirect screening method. RESULTS 4CMenB uptake in England remained consistently high; data from the first 3 months of 2018 showed that 92.5% of children had completed the primary immunizations by their first birthday and 87.9% had received all three doses by 2 years. From September 2015 through August 2018, the incidence of meningococcal group B disease in England (average annual birth cohort, approximately 650,000 infants) was significantly lower in vaccine-eligible cohorts than the expected incidence (63 observed cases as compared with 253 expected cases; incidence rate ratio, 0.25; 95% confidence interval [CI], 0.19 to 0.36), with a 75% reduction in age groups that were fully eligible for vaccination. The adjusted vaccine effectiveness against meningococcal group B disease was 52.7% (95% CI, −33.5 to 83.2) with a two-dose priming schedule for infants and 59.1% (95% CI, −31.1 to 87.2) with a two-dose priming schedule plus a booster at 1 year). Over the 3-year period, there were 169 cases of meningococcal group B disease in the vaccineeligible cohorts, and an estimated 277 cases (95% CI, 236 to 323) were prevented. CONCLUSIONS The 4CMenB program was associated with continued positive effect against meningococcal group B disease in children in England, and protection after three doses of the vaccine was sustained for at least 2 years.

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“…Vaccines against meningococcal diseases caused by serotypes B (MenB) and C (MenC) are well tolerated in extremely preterm infants [ 35 ]. A trend toward lower GMTs in preterm infants was observed after primary immunization, while a booster dose induced comparable antibody levels in preterm and term infants at the age of one year [ 36 ].…”

Section: Vaccinations Against Neisseria Meningitidis (Meningococci)—t...mentioning

confidence: 99%

Immunization of preterm infants: current evidence and future strategies to individualized approaches

et al. 2022

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Preterm infants are at particularly high risk for infectious diseases. As this vulnerability extends beyond the neonatal period into childhood and adolescence, preterm infants benefit greatly from infection-preventive measures such as immunizations. However, there is an ongoing discussion about vaccine safety and efficacy due to preterm infants’ distinct immunological features. A significant proportion of infants remains un- or under-immunized when discharged from primary hospital stay. Educating health care professionals and parents, promoting maternal immunization and evaluating the potential of new vaccination tools are important means to reduce the overall burden from infectious diseases in preterm infants. In this narrative review, we summarize the current knowledge about vaccinations in premature infants. We discuss the specificities of early life immunity and memory function, including the role of polyreactive B cells, restricted B cell receptor diversity and heterologous immunity mediated by a cross-reactive T cell repertoire. Recently, mechanistic studies indicated that tissue-resident memory (Trm) cell populations including T cells, B cells and macrophages are already established in the fetus. Their role in human early life immunity, however, is not yet understood. Tissue-resident memory T cells, for example, are diminished in airway tissues in neonates as compared to older children or adults. Hence, the ability to make specific recall responses after secondary infectious stimulus is hampered, a phenomenon that is transcriptionally regulated by enhanced expression of T-bet. Furthermore, the microbiome establishment is a dominant factor to shape resident immunity at mucosal surfaces, but it is often disturbed in the context of preterm birth. The proposed function of Trm T cells to remember benign interactions with the microbiome might therefore be reduced which would contribute to an increased risk for sustained inflammation. An improved understanding of Trm interactions may determine novel targets of vaccination, e.g., modulation of T-bet responses and facilitate more individualized approaches to protect preterm babies in the future.

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Safety of meningococcal group B vaccination in hospitalised premature infants

Cited by 15 publications

References 13 publications

Gene expression profiling reveals insights into infant immunological and febrile responses to group B meningococcal vaccine

Gene expression profiling reveals insights into infant immunological and febrile responses to group B meningococcal vaccine

Vaccination of Infants with Meningococcal Group B Vaccine (4CMenB) in England

Immunization of preterm infants: current evidence and future strategies to individualized approaches

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