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Vaccine Jun 2023Immunogenicity to meningococcal serogroup ACWY (MenACWY) conjugate vaccine has not been studied in immunocompromised minors with juvenile idiopathic arthritis (JIA) or... (Observational Study)
Observational Study
Meningococcal ACWY conjugate vaccine immunogenicity and safety in adolescents with juvenile idiopathic arthritis and inflammatory bowel disease: A prospective observational cohort study.
BACKGROUND
Immunogenicity to meningococcal serogroup ACWY (MenACWY) conjugate vaccine has not been studied in immunocompromised minors with juvenile idiopathic arthritis (JIA) or inflammatory bowel disease (IBD). We determined immunogenicity of a MenACWY-TT vaccine in JIA and IBD patients at adolescent age and compared results to data from aged-matched healthy controls (HCs).
METHODS
We performed a prospective observational cohort study in JIA and IBD patients (14-18 years old), who received a MenACWY vaccination during a nationwide catch-up campaign (2018-2019) in the Netherlands. Primary aim was to compare MenACWY polysaccharide-specific serum IgG geometric mean concentrations (GMCs) in patients with HCs and secondary between patients with or without anti-TNF therapy. GMCs were determined before and 3-6, 12, and 24 months postvaccination and compared with data from HCs at baseline and 12 months postvaccination. Serum bactericidal antibody (SBA) titers were determined in a subset of patients at 12 months postvaccination.
RESULTS
We included 226 JIA and IBD patients (66 % and 34 % respectively). GMCs were lower for MenA and MenW (GMC ratio 0·24 [0·17-0·34] and 0·16 [0·10-0·26] respectively, p < 0·01) in patients compared to HCs at 12 months postvaccination. Anti-TNF users had lower MenACWY GMCs postvaccination compared with those without anti-TNF (p < 0·01). The proportion protected (SBA ≥ 8) for MenW was reduced in anti-TNF users (76 % versus 92 % in non-anti-TNF and 100 % in HCs, p < 0.01).
CONCLUSION
The MenACWY conjugate vaccine was immunogenic in the vast majority of JIA and IBD patients at adolescent age, but seroprotection was lower in patients using anti-TNF agents. Therefore, an extra booster MenACWY vaccination should be considered.
Topics: Adolescent; Humans; Antibodies, Bacterial; Arthritis, Juvenile; Immunogenicity, Vaccine; Meningococcal Infections; Meningococcal Vaccines; Prospective Studies; Vaccines, Conjugate
PubMed: 37198018
DOI: 10.1016/j.vaccine.2023.04.056 -
Human Vaccines & Immunotherapeutics Mar 2021Meningococcal serogroups A and C cause significant numbers of cases in China. The Sanofi Pasteur meningococcal polysaccharide A + C vaccine (Men-AC) was licensed in... (Randomized Controlled Trial)
Randomized Controlled Trial
Safety and immunogenicity of meningococcal (Groups A and C) polysaccharide vaccine in children 2 to 6 y of age in China: a randomized, active-controlled, non-inferiority study.
Meningococcal serogroups A and C cause significant numbers of cases in China. The Sanofi Pasteur meningococcal polysaccharide A + C vaccine (Men-AC) was licensed in China in 1995. Immunogenicity and safety of a single dose of Men-AC against a similar marketed vaccine, the Lanzhou Institute serogroups A and C vaccine (Lanzhou-AC), were evaluated in children 2 to 6 y of age. Antibody titers were determined before and on Day 30 after vaccination using a serum bactericidal assay using baby rabbit complement (SBA-BR). Immunogenicity endpoints included rates of seroconversion (postvaccination antibody titers ≥4-fold higher) and seroprotection (postvaccination titers ≥1:8). Unsolicited systemic adverse events (AEs) within 30 minutes after vaccination, solicited injection site and systemic reactions between Days 0 and 7, unsolicited non-serious AEs within 30 d, and serious adverse events (SAEs) throughout were recorded. Seroconversion rates against serogroups A and C were 97.0% (95% confidence interval [CI], 94.5-98.6) and 94.7% (95% CI, 91.6-97.0), respectively, in the Men-AC group and 97.7% (95% CI, 95.4-99.1) and 94.8% (95% CI, 91.7-97.0), respectively, in the Lanzhou-AC group, while seroprotection rates were 98.0% (95% CI, 95.8-99.3) and 97.0% (95% CI, 94.5-98.6), respectively, in the Men-AC group and 99.0% (95% CI, 97.2-99.8) and 96.8% (95% CI, 94.1-98.4), respectively, in the Lanzhou-AC group. Non-inferiority of Men-AC with regard to immunogenicity was demonstrated since the lower bounds of the 95% CIs of the differences in rates between the two groups were > -5% for both serogroups. Both vaccines were well tolerated.
Topics: Animals; Rabbits; Antibodies, Bacterial; China; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis; Vaccines, Conjugate; Humans; Child, Preschool; Child; Equivalence Trials as Topic
PubMed: 33270487
DOI: 10.1080/21645515.2020.1801077 -
Clinical Infectious Diseases : An... Jul 2021From 2017, a statewide cluster randomized trial was conducted in South Australia to assess the impact of the meningococcal B vaccine 4CMenB on pharyngeal Neisseria... (Observational Study)
Observational Study Randomized Controlled Trial
BACKGROUND
From 2017, a statewide cluster randomized trial was conducted in South Australia to assess the impact of the meningococcal B vaccine 4CMenB on pharyngeal Neisseria meningitidis carriage in adolescents. Senior schools were randomized to receive the vaccine in 2017 (intervention) or 2018 (control). In this study we report the vaccine impact of 4CMenB on serogroup B invasive meningococcal disease (IMD) in 16- to 19-year-old adolescents in South Australia.
METHODS
This observational time series analysis of serogroup B IMD cases compares the 14 years prior to the commencement of the trial (2003-2016) with the 2 years following 4CMenB vaccination of the 2017 adolescent cohort.
RESULTS
Approximately 62% of year 10 and 11 students (15-16 years old) in South Australia enrolled in the trial. A total of 30 522 year 10-12 students received at least 1 dose of 4CMenB. The number of serogroup B IMD cases in 16- to 19-year old adolescents in South Australia increased on average by 10% per year from 2003 to 2016 (95% confidence interval [CI], 6%-15%, P < .001), peaking with 10 cases in 2015. Serogroup B IMD cases reduced to 5 in 2017-2018 and 1 in 2018-2019, below the expected numbers of 9.9 (95% prediction interval [PI], 3.9-17.5) and 10.9 (95% PI, 4.4-19.1), respectively. This translated to an overall reduction in the number of serogroup B IMD cases of 71% (95% CI, 15%-90%, P = .02). There were no serogroup B IMD cases in vaccinated adolescents.
CONCLUSIONS
Vaccinating adolescents with 4CMenB was associated with a reduction in group B meningococcal disease in South Australia.
CLINICAL TRIALS REGISTRATION
NCT03089086.
Topics: Adolescent; Adult; Humans; Infant; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis; Neisseria meningitidis, Serogroup B; South Australia; Young Adult
PubMed: 33587122
DOI: 10.1093/cid/ciaa1636 -
Mayo Clinic Proceedings Aug 2020In addition to the vaccines due in the first year of life, the US Advisory Committee on Immunization Practices recommends that children continue to receive vaccines... (Review)
Review
In addition to the vaccines due in the first year of life, the US Advisory Committee on Immunization Practices recommends that children continue to receive vaccines regularly against a variety of infectious diseases. Starting at 12 to 15 months of life, these include the two-dose measles-mumps-rubella vaccine series and the two-dose varicella vaccine series. Also in the second year of life, infants should begin the two-dose hepatitis A vaccine series and complete the Haemophilus influenzae type B vaccine series as well as the pneumococcal conjugate vaccine series. Before 19 months of life, infants should receive the third dose of the poliovirus vaccine and the fourth dose of diphtheria-tetanus-acellular pertussis (DTaP) vaccine. The final doses of poliovirus and tetanus-diphtheria-acellular pertussis vaccines are both due at 4 to 6 years of life. Before each influenza season, every child should receive the influenza vaccine. Those less than 9 years of age who previously received less than two doses need two doses a month apart. At 11 to 12 years of life, all should get two doses of the human papillomavirus vaccine, the adolescent/adult version of the tetanus-diphtheria-acellular pertussis vaccine, and begin a two-dose series of meningococcal ACWY vaccine. Each of these vaccines is due when the vaccine works to protect against both an immediate risk as well as to provide long-term protection. Each vaccine-preventable disease varies in terms of the nature of exposure, the form of the morbidity, the risk of mortality, and potential to prevent or ameliorate its harm.
Topics: Adolescent; Age Factors; Chickenpox Vaccine; Child; Child, Preschool; Diphtheria-Tetanus-Pertussis Vaccine; Female; Hepatitis A Vaccines; Humans; Infant; Influenza Vaccines; Male; Measles Vaccine; Meningococcal Vaccines; Mumps Vaccine; Papillomavirus Vaccines; Rubella Vaccine; Sex Factors; Vaccines
PubMed: 32753151
DOI: 10.1016/j.mayocp.2020.06.004 -
Archives of Disease in Childhood Aug 2020Meningococcal disease remains one of the most feared infectious diseases worldwide because of its sudden onset, rapid progression and high case fatality rates, while... (Review)
Review
Meningococcal disease remains one of the most feared infectious diseases worldwide because of its sudden onset, rapid progression and high case fatality rates, while survivors are often left with severe long-term sequelae. Young children have the highest incidence of invasive meningococcal disease (IMD), and nearly all cases in the UK, as in most of Europe and many other industrialised countries, are due to group B meningococci (MenB). The licensure of a broad-coverage, recombinant protein-based MenB vaccine (4CMenB) in 2013 was, therefore, heralded a major breakthrough in the fight against IMD. This vaccine was, however, licensed on immunogenicity and reactogenicity studies only, raising uncertainties about field effectiveness, long-term safety and antibody persistence. In 2015, the UK became the first country to implement 4CMenB into the national infant immunisation schedule and, since then, several countries have followed suit. Seven years after licensure, a wealth of real-world data has emerged to confirm 4CMenB effectiveness, along with large-scale safety data, duration of protection in different age groups, successful strategies to reduce vaccine reactogenicity, impact on carriage in adolescents and the potential for 4CMenB to protect against other meningococcal serogroups and against gonorrhoea. A number of questions, however, remain unanswered, including the investigation and management of vaccine-associated fever in infants, as well as disease severity and assessment of breakthrough cases in immunised children. Increasing use of 4CMenB will provide answers in due course. We now have vaccines against all the major serogroups causing IMD worldwide. Next-generation and combination vaccines against multiple serogroups look very promising.
Topics: Child; Child Health; Child, Preschool; Global Health; Humans; Infant; Meningitis, Meningococcal; Meningococcal Vaccines
PubMed: 32029437
DOI: 10.1136/archdischild-2019-318047 -
Current Opinion in Nephrology and... Nov 2019Kidney transplant recipients are at high risk of contracting infections, some of which are considered vaccine-preventable, because of their highly immunosuppressed... (Review)
Review
PURPOSE OF REVIEW
Kidney transplant recipients are at high risk of contracting infections, some of which are considered vaccine-preventable, because of their highly immunosuppressed state. In this vulnerable group of patients, infection can lead to poor outcomes including graft failure and death, thus vaccination in the posttransplant population is an important strategy in order to mitigate this risk. The present review is aimed at providing an update on recent advances with respect to vaccination strategies in kidney transplant recipients.
RECENT FINDINGS
General principles behind vaccination in kidney transplantation have remained consistent over many years. More recently, efforts have been focused on developing newer strategies for vaccination against influenza and herpes zoster in organ transplant recipients. Newer data on the immunogenicity of vaccines directed against pneumococcal disease, human papillomavirus, and hepatitis B virus in kidney transplant recipients have become available and will also be discussed in the present review.
SUMMARY
Kidney transplant recipients are highly-vulnerable to contracting serious infections by way of their immunosuppressed state and their dampened ability to mount an immunogenic response to vaccines. Thus, ongoing advances in vaccination strategies in this group of patients should be an important area of focus of future research in order to help promote healthier living and greater survival postkidney transplant.
Topics: Hepatitis B Vaccines; Herpes Zoster Vaccine; Humans; Influenza Vaccines; Kidney Transplantation; Meningococcal Vaccines; Papillomavirus Vaccines; Pneumococcal Vaccines; Vaccination
PubMed: 31567282
DOI: 10.1097/MNH.0000000000000546 -
The Medical Journal of Australia Feb 2020Invasive meningococcal disease (IMD) is an uncommon but life-threatening infection caused by Neisseria meningitidis. Serogroups B, C, W and Y cause most IMD cases in... (Review)
Review
Invasive meningococcal disease (IMD) is an uncommon but life-threatening infection caused by Neisseria meningitidis. Serogroups B, C, W and Y cause most IMD cases in Australia. The highest incidence occurs in children under 5 years of age. A second peak occurs in adolescents and young adults, which is also the age of highest carriage prevalence of N. meningitidis. Meningococcal serogroup B (MenB) disease predominated nationally before 2016 and has remained the predominant cause of IMD in South Australia with 82% of cases, compared with 35% in New South Wales, 35% in Queensland, 9% in Victoria, 29% in Western Australia and 36% nationally in 2016. MenB vaccination is recommended by the Australian Technical Advisory Group on Immunisation for infants up to 2 years of age and adolescents aged 15-19 years (age 15-24 years for at-risk groups, such as people living in close quarters or smokers), laboratory workers with exposure to N. meningitidis, and Aboriginal and Torres Strait Islander children from age 2 months to 19 years. Due to the epidemiology and disease burden from MenB, a meningococcal B vaccine program has been implemented in South Australia for individuals with age-specific incidence rates higher than the mean rate of 2.8/100 000 population in South Australia in the period 2000-2017, including infants, young children (< 4 years) and adolescents (15-20 years). Program evaluation of vaccine effectiveness against IMD is important. As observational evidence also suggests 4CMenB may have an impact on Neisseria gonorrhoeae with genetic homology between bacterial species, the vaccine impact on gonorrhoea will also be assessed.
Topics: Adolescent; Child; Child, Preschool; Humans; Immunization Programs; Incidence; Infant; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis; Prevalence; Serogroup; South Australia; Vaccination; Young Adult
PubMed: 31909501
DOI: 10.5694/mja2.50481 -
Expert Review of Vaccines 2023Serogroups A, B, C, W, X, and Y of Neisseria meningitidis are responsible for almost all cases of invasive meningococcal disease. In Italy, vaccination against serogroup... (Review)
Review
INTRODUCTION
Serogroups A, B, C, W, X, and Y of Neisseria meningitidis are responsible for almost all cases of invasive meningococcal disease. In Italy, vaccination against serogroup B is recommended at 3-13 months, C at 13-15 months, and A, C, Y and W in adolescents (12-18 years). Four quadrivalent meningococcal conjugate vaccines are available. This review describes the available data on a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT; MenQuadfi®; Sanofi).
AREAS COVERED
We identified articles on quadrivalent meningococcal conjugate vaccines indexed on PubMed since 2000. Of the 524 studies identified, 10 human studies investigating the immunogenicity and safety of MenACYW-TT in toddlers, children aged 2-9 years, and individuals 10-55 or ≥56 years are described in detail.
EXPERT OPINION
In Italy, pediatric and public health groups recommend amending the current vaccination schedule to include a booster dose between 6 and 9 years and quadrivalent vaccine in young adults (≥19 years), targeting waning protection after childhood vaccination and the age cohort with the highest carrier prevalence (adolescents and young adults). MenACYW-TT is a suitable meningococcal vaccine for current and pending recommendations based on high seroprotection rates and a low incidence of adverse events in these age groups. Moreover, it does not require reconstitution.
Topics: Adolescent; Young Adult; Humans; Child; Vaccines, Conjugate; Meningococcal Vaccines; Tetanus Toxoid; Expert Testimony; Neisseria meningitidis; Meningococcal Infections; Antibodies, Bacterial
PubMed: 37144288
DOI: 10.1080/14760584.2023.2211162 -
Vaccine Mar 2022Invasive meningococcal disease (IMD) is a notifiable disease in Germany and other European countries. Due to the high lethality of the disease and the risk of long-term... (Review)
Review
INTRODUCTION
Invasive meningococcal disease (IMD) is a notifiable disease in Germany and other European countries. Due to the high lethality of the disease and the risk of long-term consequences, IMD prevention is of high public health relevance despite the low number of cases in the population. This study aims to describe key epidemiological and economic parameters of IMD in Germany to support national decision-making processes for implementing enhanced prevention measures.
METHODS
Based on a systematic literature review in PubMed and EMBASE, all publications on the burden of disease and costs of IMD published up to May 2020 were evaluated. Additionally, notification data were used to report the annual case numbers and incidence of IMD in Germany until the end of 2019.
RESULTS
Thirty-six studies were included, of which 35 reported data on the epidemiological burden of disease and three reported data on economic aspects of IMD. The type of reported endpoints and results on the incidence of IMD differed widely by reporting year, population, and data source used. Most of the data are reported without specific information about a serogroup. Data on the economic burden of disease and healthcare resource use are scarce. Based on mandatory notification data, a decrease in the incidence of notified IMD cases has been observed since 2004. Currently, the nationwide annual incidence in Germany is at 0.3 cases per 100,000 persons and has gradually decreased. While the overall decline is mainly attributable to MenB, cases with MenY and MenW are the only ones that have increased on a low level in recent years.
CONCLUSION
While IMD is a rare disease, high direct and indirect costs illustrate the relevance of the disease for patients, caregivers, as well as for the health care system. Future research should concentrate on quantifying the long-term economic burden and indirect costs of meningococcal disease. Integrated IMD surveillance with isolate characterisation remains crucial to inform public health policies.
Topics: Financial Stress; Germany; Humans; Incidence; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis; Serogroup
PubMed: 35227520
DOI: 10.1016/j.vaccine.2022.02.043 -
Epidemiologie, Mikrobiologie,... 2023In 2006-2022, 958 cases of invasive meningococcal disease (IMD) were reported to the surveillance programme in the Czech Republic, of which 21 (2.19%) had a history of...
In 2006-2022, 958 cases of invasive meningococcal disease (IMD) were reported to the surveillance programme in the Czech Republic, of which 21 (2.19%) had a history of vaccination with one of the meningococcal vaccines. Data analysis shows that these vaccines provide a very good protection against IMD. It was found that vaccinated patients with IMD either were not vaccinated against the causative serogroup and/or did not receive a booster dose. The results of this analysis show the benefit of both vaccines available in the Czech Republic: recombinant vaccine containing meningococcal serogroup B antigens (MenB vaccine) and tetravalent conjugate vaccine containing antigens of four meningococcal serogroups A, C, W, Y (A, C, W, Y conjugate vaccine). The results also show the benefit of meningococcal vaccine booster doses and the need for giving MenB vaccine to young children as early as possible.
Topics: Child; Humans; Child, Preschool; Meningococcal Vaccines; Czech Republic; Vaccines, Conjugate; Meningococcal Infections; Neisseria meningitidis; Vaccination; Neisseria meningitidis, Serogroup B; Serogroup
PubMed: 38242709
DOI: No ID Found