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Human Vaccines & Immunotherapeutics Dec 2024Vaccine co-administration is a useful strategy for improving vaccine coverage and adherence. In Italy, an update to the national immunization program (NIP) in 2023... (Review)
Review
Vaccine co-administration is a useful strategy for improving vaccine coverage and adherence. In Italy, an update to the national immunization program (NIP) in 2023 included recommendations for co-administration of pediatric vaccines, including the four-component vaccine for meningococcus B (4CMenB), pneumococcal conjugate vaccine (PCV), hexavalent vaccines, and oral rotavirus vaccines. Safety is a major concern when considering vaccine co-administration; therefore, a literature review of the available evidence on 4CMenB co-administration with PCV, hexavalent/pentavalent, and rotavirus vaccines was performed. Of 763 publications screened, two studies were reviewed that reported safety data on 4CMenB co-administration with PCV, hexavalent/pentavalent, and rotavirus vaccines in infants aged 0-24 months. Overall, these studies supported that there were no significant safety signals when co-administering 4CMenB with PCV, hexavalent/pentavalent, and rotavirus vaccines, compared with individual vaccination. This review provides key insights for healthcare professionals on the tolerability of co-administering 4CMenB with routine vaccines.
Topics: Humans; Infant; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis, Serogroup B; Rotavirus Vaccines; Vaccination; Vaccines, Conjugate; Infant, Newborn; Pneumococcal Vaccines
PubMed: 38566502
DOI: 10.1080/21645515.2024.2333106 -
Medical Sciences (Basel, Switzerland) Dec 2023( serogroup B (MenB) is the leading cause of invasive meningococcal disease worldwide. The pathogen has a wide range of virulence factors, which are potential vaccine...
( serogroup B (MenB) is the leading cause of invasive meningococcal disease worldwide. The pathogen has a wide range of virulence factors, which are potential vaccine components. Studying the genetic variability of antigens within a population, especially their long-term persistence, is necessary to develop new vaccines and predict the effectiveness of existing ones. The multicomponent 4CMenB vaccine (Bexsero), used since 2014, contains three major genome-derived recombinant proteins: factor H-binding protein (fHbp), Heparin-Binding Antigen (NHBA) and adhesin A (NadA). Here, we assessed the prevalence and sequence variations of these vaccine antigens in a panel of 5667 meningococcal isolates collected worldwide over the past 10 years and deposited in the PubMLST database. Using multiple amino acid sequence alignments and Random Forest Classifier machine learning methods, we estimated the potential strain coverage of fHbp and NHBA vaccine variants (51 and about 25%, respectively); the NadA antigen sequence was found in only 18% of MenB genomes analyzed, but cross-reactive variants were present in less than 1% of isolates. Based on our findings, we proposed various strategies to improve the 4CMenB vaccine and broaden the coverage of strains.
Topics: Humans; Antigens, Bacterial; Meningococcal Infections; Meningococcal Vaccines; Vaccine Efficacy; Neisseria meningitidis, Serogroup B; Adhesins, Bacterial; Neisseria meningitidis; Neisseria; Computational Biology; Prognosis
PubMed: 38132917
DOI: 10.3390/medsci11040076 -
PharmacoEconomics - Open May 2024In France, meningococcal serogroup B (MenB) is the most common serogroup causing invasive meningococcal disease (IMD) in infants and young children. Our objective was to...
BACKGROUND AND OBJECTIVES
In France, meningococcal serogroup B (MenB) is the most common serogroup causing invasive meningococcal disease (IMD) in infants and young children. Our objective was to illustrate the impact of model choices on health outcomes and the cost-effectiveness of infant vaccination with the multicomponent meningococcal serogroup B vaccine (4CMenB) versus no vaccine in France.
METHODS
A previously published dynamic transmission-based cost-effectiveness model was adapted for the French context using updated, French-specific demographic, epidemiological, and cost data. IMD incidence and long-term sequelae were derived through analysis of French healthcare and surveillance databases. A collective perspective over a 100-year time horizon was adopted, with a discount rate of 2.5%, reduced to 1.5% after the first 30 years. Deterministic and probabilistic sensitivity and scenario analyses were performed.
RESULTS
In the base case analysis, infant vaccination with 4CMenB avoided 3101 MenB IMD cases in infants aged < 1 year (- 54%) and 6845 cases in all age groups (- 21%). The estimated incremental cost-effectiveness ratio was €316,272/quality-adjusted life-year (QALY) but was highly sensitive to the types of sequelae included, MenB incidence, vaccine effectiveness parameters, and consideration of life-expectancy in IMD survivors (range: €65,272/QALY to €493,218/QALY).
CONCLUSIONS
Using economic models compliant with French methodology guidelines, 4CMenB does not seem cost-effective; however, results are sensitive to model choices and 4CMenB immunization is an effective strategy to prevent MenB IMD cases and to improve quality of life and economic burden associated with MenB IMD treatment, especially with regard to long-term sequelae.
PubMed: 38780884
DOI: 10.1007/s41669-024-00488-5 -
The Lancet. Infectious Diseases Nov 2023Bivalent BA.1 booster vaccines were offered to adults aged 50 years or older and clinically vulnerable people as part of the 2022 autumn COVID-19 booster vaccination...
Duration of protection of ancestral-strain monovalent vaccines and effectiveness of bivalent BA.1 boosters against COVID-19 hospitalisation in England: a test-negative case-control study.
BACKGROUND
Bivalent BA.1 booster vaccines were offered to adults aged 50 years or older and clinically vulnerable people as part of the 2022 autumn COVID-19 booster vaccination programme in England. Previously, all adults in England had been offered a primary course consisting of two doses of either ChAdOx1-S or monovalent mRNA vaccine and an mRNA monovalent booster vaccine. We aimed to estimate the long-term duration of protection provided by monovalent COVID-19 vaccines, and the incremental vaccine effectiveness of bivalent BA.1 boosters.
METHODS
In this test-negative case-control study, cases of COVID-19 and controls aged 18 years or older were identified from national data for PCR tests done in hospital settings in England. Our analysis was restricted to people with acute respiratory infections coded in the primary diagnosis field. Data for vaccination status were extracted from the English national vaccine register and linked to COVID-19 testing data. Between June 13 and Dec 25, 2022, we estimated the vaccine effectiveness against hospitalisation of two or three or more doses of monovalent COVID-19 vaccines compared with being unvaccinated, stratified by age (18-64 years vs ≥65 years). Between Sept 5, 2022, and Feb 5, 2023, we estimated the incremental vaccine effectiveness (ie, in addition to the protection from earlier vaccines) of receiving a bivalent BA.1 booster vaccine in addition to at least two doses of a monovalent vaccine (when the last dose was at least 6 months ago) among people aged 50 years or older. Analyses were adjusted for week of test, gender, age, COVID-19 risk group, residing in a care home, being a health or social care worker, Index of Multiple Deprivation quintile, ethnicity, and recent COVID-19 positivity.
FINDINGS
Our analysis of monovalent COVID-19 vaccines included 19 841 cases and 43 410 controls. Absolute vaccine effectiveness against hospitalisation among people who had received at least three doses plateaued from 6 months after the last dose at around 50% in those aged 65 years or older and at around 30% in those aged 18-64 years. Our analyses of the effectiveness of bivalent BA.1 boosters included data for 9954 cases and 39 108 controls aged 50 years or older. Incremental vaccine effectiveness peaked at 53·0% (95% CI 47·9-57·5) 2-4 weeks after administration, before waning to 35·9% (31·4-40·1) after 10 or more weeks.
INTERPRETATION
Our study provides evidence that monovalent COVID-19 vaccines offer moderate long-term protection against hospitalisation in people aged 65 years or older and that the bivalent BA.1 booster vaccines were effective in preventing hospitalisation among people aged 50 years or older at a time when omicron lineages were circulating in England.
FUNDING
None.
Topics: Adult; Humans; COVID-19 Vaccines; COVID-19; COVID-19 Testing; Case-Control Studies; Vaccines; Hospitalization; Vaccines, Combined; ChAdOx1 nCoV-19; England
PubMed: 37453440
DOI: 10.1016/S1473-3099(23)00365-1 -
Vaccine Dec 2023An affordable, accessible, and broadly protective vaccine is required to tackle the re-occurring bacterial meningococcal epidemics in Sub-Saharan Africa as well as an...
An affordable, accessible, and broadly protective vaccine is required to tackle the re-occurring bacterial meningococcal epidemics in Sub-Saharan Africa as well as an effective control of multi-drug resistant strains of gonococcus. Outer membrane vesicles (OMVs) secreted from Gram-negative bacteria represent an attractive platform for antigen delivery to the immune system and therefore for development of multi-component vaccines. In this study, we describe the generation of modified OMVs (mOMVs) from commensal biosafety-level 1 (BSL-1) Neisseria cinerea ATCC® 14685, which is phylogenetically close to the pathogenic bacteria Neisseria meningitidis and Neisseria gonorrhoeae. mOMVs were prepared from N. cinerea engineered to express heterologous antigens from N. meningitidis (factor H binding protein (fHbp) and Neisseria Heparin Binding Antigen (NHBA-2)) and from N. gonorrhoeae (NHBA-542). Mice immunised with the mOMVs produced antibodies against fHbp and NHBA. The work indicates that mOMV from N. cinerea can be used as a platform to induce immune responses against antigens involved in the protective immune response against meningococcal and gonococcal diseases.
Topics: Mice; Animals; Neisseria cinerea; Bacterial Proteins; Antigens, Bacterial; Neisseria meningitidis; Meningococcal Vaccines; Bacterial Vaccines; Neisseria gonorrhoeae; Immune System; Antibodies, Bacterial
PubMed: 38008665
DOI: 10.1016/j.vaccine.2023.11.034 -
Anales de Pediatria Dec 2023The main preventive measure against invasive meningococcal disease is vaccination. The aim of our study was to evaluate the acceptability of the meningococcal B (MenB)... (Observational Study)
Observational Study
INTRODUCTION
The main preventive measure against invasive meningococcal disease is vaccination. The aim of our study was to evaluate the acceptability of the meningococcal B (MenB) vaccine and socioeconomic inequalities in the access to the vaccine in the Community of Madrid in the period prior to its introduction in the immunization schedule.
MATERIALS AND METHODS
We conducted an observational and ecological descriptive study in the cohort of children born between 2016 and 2019 using population-based electronic records. We calculated the vaccination coverage and analysed factors associated with vaccination status, determined the spatial distribution of vaccination coverage and the deprivation index (DI) and assessed the association between them by means of spatial regression.
RESULTS
We observed an increasing trend in primary vaccination coverage, from 44% in the cohort born in 2016 to 68% in the 2019 cohort. We found a statistically significant association between vaccination status and the DI (OR of primary vaccination in areas with DI5 compared to areas with DP1, 0.38; 95% confidence interval, 0.39-0.50; P<.001). The spatial analysis showed an inverse correlation between the DI and vaccination coverage.
CONCLUSIONS
The rise in the coverages of the MenB vaccine shows acceptance by the population. The association between socioeconomic level and vaccination coverage confirms the existence of health inequality and underlines the importance including this vaccine in the immunization schedule.
Topics: Child; Humans; Immunization Schedule; Health Status Disparities; Vaccination; Meningococcal Vaccines; Socioeconomic Factors
PubMed: 38016859
DOI: 10.1016/j.anpede.2023.11.006 -
PloS One 2023Pneumococcal disease is a major cause of clinical and economic burden worldwide. This study investigated the burden of pneumococcal disease in Swedish adults. A...
Pneumococcal disease is a major cause of clinical and economic burden worldwide. This study investigated the burden of pneumococcal disease in Swedish adults. A retrospective population-based study was conducted using Swedish national registers, including all adults aged ≥18 years with a diagnosis of pneumococcal disease (defined as pneumococcal pneumonia, meningitis, or septicemia) in inpatient or outpatient specialist care between 2015-2019. Incidence and 30-day case fatality rates, healthcare resource utilization, and costs were estimated. Results were stratified by age (18-64, 65-74, and ≥75 years) and the presence of medical risk factors. A total of 10,391 infections among 9,619 adults were identified. Medical factors associated with higher risk for pneumococcal disease were present in 53% of patients. These factors were associated with increased pneumococcal disease incidence in the youngest cohort. In the cohort aged 65-74 years, having a very high risk for pneumococcal disease was not associated with an increased incidence. Pneumococcal disease incidence was estimated at 12.3 (18-64), 52.1 (64-74), and 85.3 (≥75) per 100,000 population. The 30-day case fatality rate increased with age (18-64: 2.2%, 65-74: 5.4%, ≥75: 11.7%), and was highest among septicemia patients aged ≥75 (21.4%). The 30-day average number of hospitalizations was 1.13 (18-64), 1.24 (64-74) and 1.31 (≥75). The average 30-day cost/infection was estimated at €4,467 (18-64), €5,278 (65-74), and €5,898 (≥75). The 30-day total direct cost of pneumococcal disease between 2015-2019 was €54.2 million, with 95% of costs from hospitalizations. The clinical and economic burden of pneumococcal disease in adults was found to increase with age, with nearly all costs associated with pneumococcal disease from hospitalizations. The 30-day case fatality rate was highest in the oldest age group, though not negligible in the younger age groups. The findings of this study can inform the prioritization of pneumococcal disease prevention in adult and elderly populations.
Topics: Aged; Humans; Adult; Adolescent; Sweden; Retrospective Studies; Financial Stress; Pneumococcal Infections; Streptococcus pneumoniae; Pneumonia, Pneumococcal; Sepsis; Pneumococcal Vaccines
PubMed: 37418396
DOI: 10.1371/journal.pone.0287581 -
Signal Transduction and Targeted Therapy Feb 2024Pyrogen, often as a contaminant, is a key indicator affecting the safety of almost all parenteral drugs (including biologicals, chemicals, traditional Chinese medicines...
Pyrogen, often as a contaminant, is a key indicator affecting the safety of almost all parenteral drugs (including biologicals, chemicals, traditional Chinese medicines and medical devices). It has become a goal to completely replace the in vivo rabbit pyrogen test by using the in vitro pyrogen test based on the promoted 'reduction, replacement and refinement' principle, which has been highly considered by regulatory agencies from different countries. We used NF-κB, a central signalling molecule mediating inflammatory responses, as a pyrogenic marker and the monocyte line THP-1 transfected with a luciferase reporter gene regulated by NF-κB as an in vitro model to detect pyrogens by measuring the intensity of a fluorescence signal. Here, we show that this test can quantitatively and sensitively detect endotoxin (lipopolysaccharide from different strains) and nonendotoxin (lipoteichoic acid, zymosan, peptidoglycan, lectin and glucan), has good stability in terms of NF-κB activity and cell phenotypes at 39 cell passages and can be applied to detect pyrogens in biologicals (group A & C meningococcal polysaccharide vaccine; basiliximab; rabies vaccine (Vero cells) for human use, freeze-dried; Japanese encephalitis vaccine (Vero cells), inactivated; insulin aspart injection; human albumin; recombinant human erythropoietin injection (CHO Cell)). The within-laboratory reproducibility of the test in three independent laboratories was 85%, 80% and 80% and the interlaboratory reproducibility among laboratories was 83.3%, 95.6% and 86.7%. The sensitivity (true positive rate) and specificity (true negative rate) of the test were 89.9% and 90.9%, respectively. In summary, the test provides a novel alternative for pyrogen detection.
Topics: Animals; Chlorocebus aethiops; Rabbits; Humans; Pyrogens; NF-kappa B; Vero Cells; Reproducibility of Results; Cell Line
PubMed: 38369543
DOI: 10.1038/s41392-024-01744-0 -
Human Vaccines & Immunotherapeutics Dec 2023Human papillomavirus (HPV) vaccination uptake in the United States remains suboptimal, and continues to trail that of tetanus, diphtheria, and acellular pertussis (Tdap)...
Human papillomavirus (HPV) vaccination uptake in the United States remains suboptimal, and continues to trail that of tetanus, diphtheria, and acellular pertussis (Tdap) vaccination and quadrivalent meningococcal conjugate vaccination (MCV4). This is despite these three vaccines all being recommended for routine adolescent use within the 2005-2006 time period. One strategy to improve HPV vaccination is starting the vaccine series at the first opportunity - currently as young as 9 years of age. Little is known about the epidemiology of age at HPV vaccination, and the frequency of vaccination occurring at 9-10 years of age. Using 2020 National Immunization Survey-Teen (NIS-Teen) data, we analyzed age at HPV vaccine initiation and proportion of initiators completing the HPV vaccine series relative to age at initiation. Overall, 4.0% of US adolescents initiated HPV vaccination at 9-10 years of age, with higher initiation among younger birth cohorts (4.8% for 13-year-olds and 5.1% for 14-year-olds) than older cohorts (3.1% for both 16 and 17 year-olds). Age cohorts maximized HPV vaccine completion after 3-4 years. Among those initiating at ages 9-10, 93% of 13-year-olds completed the series. Among those initiating at 11-12, completion rates rose from 66% among 13-year-olds to 90.2% among 16-year-olds. Among those initiating at age 13-14, completion rose from 61% among 15-year-olds to 84.9% among 17-year-olds. This manuscript serves as a starting point of comparison for future epidemiologic evaluations of HPV vaccination at the first opportunity.
Topics: Adolescent; Humans; United States; Child; Child, Preschool; Papillomavirus Infections; Diphtheria-Tetanus-acellular Pertussis Vaccines; Immunization Schedule; Meningococcal Vaccines; Vaccination; Immunization; Papillomavirus Vaccines
PubMed: 37138466
DOI: 10.1080/21645515.2023.2204784 -
Frontiers in Cellular and Infection... 2024The genus , which colonizes mucosal surfaces, includes both commensal and pathogenic species that are exclusive to humans. The two pathogenic species are closely... (Review)
Review
The genus , which colonizes mucosal surfaces, includes both commensal and pathogenic species that are exclusive to humans. The two pathogenic species are closely related but cause quite different diseases, meningococcal sepsis and meningitis () and sexually transmitted gonorrhea ). Although obvious differences in bacterial niches and mechanisms for transmission exists, pathogenic have high levels of conservation at the levels of nucleotide sequences, gene content and synteny. Species of express broad-spectrum -linked protein glycosylation where the glycoproteins are largely transmembrane proteins or lipoproteins localized on the cell surface or in the periplasm. There are diverse functions among the identified glycoproteins, for example type IV biogenesis proteins, proteins involved in antimicrobial resistance, as well as surface proteins that have been suggested as vaccine candidates. The most abundant glycoprotein, PilE, is the major subunit of pili which are an important colonization factor. The glycans attached can vary extensively due to phase variation of protein glycosylation ( genes and polymorphic gene content. The exact roles of glycosylation in remains to be determined, but increasing evidence suggests that glycan variability can be a strategy to evade the human immune system. In addition, pathogenic and commensal appear to have significant glycosylation differences. Here, the current knowledge and implications of protein glycosylation genes, glycan diversity, glycoproteins and immunogenicity in pathogenic are summarized and discussed.
Topics: Humans; Bacterial Proteins; Glycoproteins; Glycosylation; Neisseria gonorrhoeae; Neisseria meningitidis; Polysaccharides; Meningitis, Meningococcal; Gonorrhea
PubMed: 38808060
DOI: 10.3389/fcimb.2024.1407863