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Gaceta Sanitaria 2020
Topics: Humans; Immunization Schedule; Incidence; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis; Spain
PubMed: 31767200
DOI: 10.1016/j.gaceta.2019.09.004 -
Human Vaccines & Immunotherapeutics Dec 2023Invasive meningococcal disease (IMD) is a life-threatening disease caused by and has high mortality rates. Survivors often exhibit long-term sequelae and reduced life...
Invasive meningococcal disease (IMD) is a life-threatening disease caused by and has high mortality rates. Survivors often exhibit long-term sequelae and reduced life expectancy. Disease incidence is highest in infants and toddlers, with a resurgence of cases in adolescents and older adults (>50 years of age). Substantial heterogeneity exists in the recommendations of meningococcal vaccines included in National Immunization Programs (NIPs) across countries. Recommendations are usually based on infant/toddler immunization, with some countries recommending immunization only for toddlers. While existing recommendations have led to a reduced incidence of IMD in children <5 years of age, there has been an increase in cases among adolescents and older adults. Currently, older adults are not included in the recommendations. The higher healthcare burden and the economic costs associated with IMD in these age groups suggest that it is time to consider including adolescents and older adults in NIPs to protect against IMD caused by the five most prevalent serogroups. Currently, the lack of equity of access to vaccines in the immunization programs is a glaring gap in the betterment of public health, and a broader meningococcal strategy is recommended to provide optimal protection for all age groups.
Topics: Infant; Adolescent; Humans; Aged; Meningococcal Infections; Neisseria meningitidis; Vaccination; Meningococcal Vaccines; Incidence; Immunization Programs
PubMed: 37017273
DOI: 10.1080/21645515.2023.2186111 -
Serogroup A meningococcal conjugate vaccines: building sustainable and equitable vaccine strategies.Expert Review of Vaccines May 2020For well over 100 years, meningococcal disease due to serogroup A (MenA) has caused severe epidemics globally, especially in the meningitis belt of sub-Saharan Africa. (Review)
Review
INTRODUCTION
For well over 100 years, meningococcal disease due to serogroup A (MenA) has caused severe epidemics globally, especially in the meningitis belt of sub-Saharan Africa.
AREAS COVERED
The article reviews the background and identification of MenA, the global and molecular epidemiology of MenA, and the outbreaks of MenA in the African meningitis belt. The implementation (2010) of an equitable MenA polysaccharide-protein conjugate vaccine (Ps-TT, MenAfriVac) and the strategy to control MenA in sub-Saharan Africa is described. The development of a novel multi-serogroup meningococcal conjugate vaccine (NmCV-5) that includes serogroup A is highlighted. The PubMed database (1996-2019) was searched for studies relating to MenA outbreaks, vaccine, and immunization strategies; and the Neisseria PubMLST database of 1755 MenA isolates (1915-2019) was reviewed.
EXPERT OPINION
Using strategies from the successful MenAfriVac campaign, expanded collaborative partnerships were built to develop a novel, low-cost multivalent component meningococcal vaccine that includes MenA. This vaccine promises greater sustainability and is directed toward global control of meningococcal disease in the African meningitidis belt and beyond. The new WHO global roadmap addresses the continuing problem of bacterial meningitis, including meningococcal vaccine prevention, and provides a framework for further reducing the devastation of MenA.
Topics: Africa South of the Sahara; Disease Outbreaks; Global Health; Humans; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis, Serogroup A; Vaccination
PubMed: 32321332
DOI: 10.1080/14760584.2020.1760097 -
The New England Journal of Medicine Aug 2023
Topics: Humans; Meningococcal Vaccines; Gambia; Mali; Vaccines, Conjugate
PubMed: 37590459
DOI: 10.1056/NEJMc2307375 -
Pediatrics Jun 2024The Advisory Committee on Immunization Practices, a group of medical and public health experts that provides advice to the Centers for Disease Control and Prevention,...
The Advisory Committee on Immunization Practices, a group of medical and public health experts that provides advice to the Centers for Disease Control and Prevention, normally meets 3 times per year to develop US vaccine recommendations. The Advisory Committee on Immunization Practices met February 28 to 29, 2024, to discuss coronavirus disease 2019 vaccines, chikungunya vaccines, diphtheria-tetanus vaccine, influenza vaccines, polio vaccines, respiratory syncytial virus vaccines, meningococcal vaccines, pneumococcal vaccines, and Vaxelis (Diphtheria, Tetanus, Pertussis, Inactivated Poliovirus, Haemophilus influenzae b Conjugate, and Hepatitis B Vaccine). This update summarizes the proceedings of these meetings, with an emphasis on topics that are most relevant to the pediatric population. Major updates for pediatric clinicians include information about changes on influenza vaccine composition, meningococcal vaccination considerations, updated guidance for children with a contraindication to pertussis-containing vaccines, and recommendations of the world's first chikungunya vaccine for certain populations.
Topics: Humans; Child; Advisory Committees; COVID-19 Vaccines; Meningococcal Vaccines; United States; Respiratory Syncytial Virus Vaccines; Centers for Disease Control and Prevention, U.S.; COVID-19
PubMed: 38548682
DOI: 10.1542/peds.2024-066653 -
Expert Review of Vaccines Jan 2022Vaccination is the most effective method of protecting people from invasive meningococcal disease (IMD). Of all the capsular groups, B is the most common cause of... (Review)
Review
INTRODUCTION
Vaccination is the most effective method of protecting people from invasive meningococcal disease (IMD). Of all the capsular groups, B is the most common cause of invasive meningococcal disease in many parts of the world. Despite this, adolescent meningococcal B vaccine programs have not been implemented globally, partly due to the lack of evidence for herd immunity afforded by meningococcal B vaccines.
AREAS COVERED
This review aims to synthesize the available evidence on recombinant 4 CMenB vaccines' ability to reduce pharyngeal carriage and therefore provide indirect (herd) immunity against IMD.
EXPERT OPINION
There is some evidence that the 4CMenB vaccine may induce cross-protection against non-B carriage of meningococci. However, the overall body of evidence does not support a clinically significant reduction in carriage of disease-associated or group B meningococci following 4CMenB vaccination. No additional cost-benefit from herd immunity effects should be included when modeling the cost-effectiveness of 4CMenB vaccine programs against group B IMD. 4CMenB immunization programs should focus on direct (individual) protection for groups at greatest risk of meningococcal disease. Future meningococcal B and combination vaccines being developed should consider the impact of the vaccine on carriage as part of their clinical evaluation.
Topics: Adolescent; Humans; Immunity, Herd; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis, Serogroup B
PubMed: 34747302
DOI: 10.1080/14760584.2022.2003708 -
Expert Review of Vaccines 2023Invasive meningococcal disease (IMD) is a severe, life-threatening condition caused by infection with . Currently available vaccines offer protection against the five... (Review)
Review
INTRODUCTION
Invasive meningococcal disease (IMD) is a severe, life-threatening condition caused by infection with . Currently available vaccines offer protection against the five most common meningococcal disease-causing serogroups and include monovalent and quadrivalent conjugate vaccines (MenA, MenC, MenACWY vaccines) and outer membrane vesicle- and/or recombinant protein-based vaccines (MenB vaccines).
AREAS COVERED
Country and regional immunization programs target populations susceptible to IMD and typically emphasize the highest-risk age groups (i.e., infants, adolescents/young adults, and the elderly); however, additional groups are also considered at an elevated risk and are the focus of the current review. Specific increased-risk groups include individuals with underlying immunocompromising medical conditions, university/college students, Indigenous people, laboratory workers, military personnel, men who have sex with men, and travelers to areas with hyperendemic IMD. This review compares established meningococcal vaccination recommendations for these vulnerable groups in Europe, the United States, Australia, New Zealand, Israel, Brazil, and Turkey.
EXPERT OPINION
Recommendations should be standardized to cover all groups at increased risk of IMD.
Topics: Infant; Male; Adolescent; Young Adult; Humans; United States; Aged; Meningococcal Vaccines; Homosexuality, Male; Vaccination; Sexual and Gender Minorities; Meningococcal Infections; Neisseria meningitidis; Vaccines, Conjugate
PubMed: 37767607
DOI: 10.1080/14760584.2023.2245467 -
The Lancet. Infectious Diseases Dec 2023Meningococcal serogroups A, B, C, W, and Y cause nearly all meningococcal disease, and comprehensive protection requires vaccination against all five serogroups. We... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Meningococcal serogroups A, B, C, W, and Y cause nearly all meningococcal disease, and comprehensive protection requires vaccination against all five serogroups. We aimed to assess the immunogenicity and safety of a pentavalent MenABCWY vaccine comprising two licensed vaccines-meningococcal serogroup B-factor H binding protein vaccine (MenB-FHbp) and a quadrivalent meningococcal serogroup ACWY tetanus toxoid conjugate vaccine (MenACWY-TT)-compared with two doses of MenB-FHbp and a single dose of quadrivalent meningococcal serogroup ACWY CRM-conjugate vaccine (MenACWY-CRM) as the active control. We previously reported the primary safety and immunogenicity data relating to the two-dose MenB-FHbp schedule. Here we report secondary outcomes and ad-hoc analyses relating to MenABCWY immunogenicity and safety.
METHODS
We did an observer-blind, active-controlled trial at 68 sites in the USA, Czech Republic, Finland, and Poland. Healthy individuals (aged 10-25 years) who had or had not previously received a MenACWY vaccine were randomly assigned (1:2) using an interactive voice or web-based response system, stratified by previous receipt of a MenACWY vaccine, to receive 0·5 mL of MenABCWY (months 0 and 6) and placebo (month 0) or MenB-FHbp (months 0 and 6) and MenACWY-CRM (month 0) via intramuscular injection into the upper deltoid. All individuals were masked to group allocation, except staff involved in vaccine dispensation, preparation, and administration; and protocol adherence. Endpoints for serogroups A, C, W, and Y included the proportion of participants who achieved at least a four-fold increase in serum bactericidal antibody using human complement (hSBA) titres between baseline and 1 month after each vaccination. For serogroup B, secondary endpoints included the proportion of participants who achieved at least a four-fold increase in hSBA titres from baseline for each of four primary test strains and the proportion of participants who achieved titres of at least the lower limit of quantitation against all four test strains combined at 1 month after the second dose. Endpoints for serogroups A, C, W, and Y were assessed in the modified intent-to-treat (mITT) population, which included all randomly assigned participants who received at least one vaccine dose and had at least one valid and determinate MenB or serogroup A, C, W, or Y assay result before vaccination up to 1 month after the second dose, assessed in ACWY-experienced and ACWY-naive participants separately. Secondary endpoints for serogroup B were analysed in the evaluable immunogenicity population, which included all participants in the mITT population who were randomly assigned to the group of interest, received all investigational products as randomly assigned, had blood drawn for assay testing within the required time frames, had at least one valid and determinate MenB assay result after the second vaccination, and had no important protocol deviations; outcomes were assessed in both ACWY-experienced and ACWY-naive populations combined. Non-inferiority of MenABCWY to MenACWY-CRM and MenB-FHbp was determined using a -10% non-inferiority margin for these endpoints. Reactogenicity and adverse events were assessed among all participants who received at least one vaccine dose and who had available safety data. This trial is registered with Clinicaltrials.gov, NCT03135834, and is complete.
FINDINGS
Between April 24 and November 10, 2017, 1610 participants (809 MenACWY-naive; 801 MenACWY-experienced) were randomly assigned: 544 to receive MenABCWY and placebo (n=272 MenACWY-naive; n=272 MenACWY-experienced) and 1066 to receive MenB-FHbp and MenACWY-CRM (n=537 MenACWY-naive; n=529 MenACWY-experienced). Among MenACWY-naive or MenACWY-experienced MenABCWY recipients, 75·5% (95% CI 69·8-80·6; 194 of 257; serogroup C) to 96·9% (94·1-98·7; 254 of 262; serogroup A) and 93·0% (88·4-96·2; 174 of 187; serogroup Y) to 97·4% (94·4-99·0; 224 of 230; serogroup W) achieved at least four-fold increases in hSBA titres against serogroups ACWY after dose 1 or 2, respectively, in ad-hoc analyses. Additionally, 75·8% (71·5-79·8; 320 of 422) to 94·7% (92·1-96·7; 396 of 418) of MenABCWY and 67·4% (64·1-70·6; 563 of 835) to 95·0% (93·3-96·4; 782 of 823) of MenB-FHbp recipients achieved at least four-fold increases in hSBA titres against MenB strains after dose 2 in secondary analyses; 79·9% (334 of 418; 75·7-83·6) and 74·3% (71·2-77·3; 605 of 814), respectively, achieved composite responses. MenABCWY was non-inferior to MenACWY-CRM (single dose) and to MenB-FHbp in ad-hoc analyses based on the proportion of participants with at least a four-fold increase in hSBA titres from baseline and (for MenB-FHbp only) composite responses. Reactogenicity events after vaccination were similarly frequent across groups, were mostly mild or moderate, and were unaffected by MenACWY experience. No adverse events causing withdrawals were related to the investigational product. Serious adverse events were reported in four (1·5%; 0·4-3·7) MenACWY-naive individuals in the MenABCWY group versus six (2·2%; 0·8-4·8) among MenACWY-experienced individuals in the MenABCWY group and 14 (1·3%; 0·7-2·2) in the active control group (MenACWY-experienced and MenACWY-naive individuals combined); none of these were considered related to the investigational product.
INTERPRETATION
MenABCWY immune responses were robust and non-inferior to MenACWY-CRM and MenB-FHbp administered separately, and MenABCWY was well tolerated. The favourable benefit-risk profile supports further MenABCWY evaluation as a simplified schedule compared with current adolescent meningococcal vaccination programmes.
FUNDING
Pfizer.
Topics: Humans; Adolescent; Young Adult; Vaccines, Conjugate; Meningococcal Infections; Neisseria meningitidis; Vaccination; Neisseria meningitidis, Serogroup B; Meningococcal Vaccines; Vaccines, Combined; Antibodies, Bacterial; Immunogenicity, Vaccine
PubMed: 37579773
DOI: 10.1016/S1473-3099(23)00191-3 -
Lancet (London, England) Apr 2020
Topics: Humans; Meningitis; Meningococcal Vaccines
PubMed: 32305081
DOI: 10.1016/S0140-6736(20)30865-5 -
The Annals of Pharmacotherapy Jun 2022This article reviews data encompassing the pharmacology, efficacy, and safety of MenACWY-TT (MenQuadfi), a conjugate vaccine to prevent meningococcal disease from... (Review)
Review
OBJECTIVE
This article reviews data encompassing the pharmacology, efficacy, and safety of MenACWY-TT (MenQuadfi), a conjugate vaccine to prevent meningococcal disease from serogroups A, C, W, Y.
DATA SOURCES
A literature review was conducted in PubMed, MEDLINE, and ClinicalTrials.gov from inception up to July 2021, using the search terms , , and . Articles from reference lists were included to identify potential relevant literature.
STUDY SELECTION AND DATA EXTRACTION
Data were limited to randomized phase II and III clinical studies published in the English language, evaluating the efficacy and safety of MenACWY-TT. Animal studies and studies not utilizing MenACWY-TT were excluded.
DATA SYNTHESIS
One phase II and 4 phase III randomized clinical studies, enrolling approximately 7700 participants, aged 2 years to 97 years old found that MenACWY-TT was noninferior when compared to established MenACWY vaccines, as measured by surrogate immunogenicity end points. In studies evaluating primary dose vaccination, conducted in those aged 2 to 97 years of age, the difference in seroresponse rates, reported by the lower bound of the 95% CI, was (A) 1.1% to 14.8%, (C) 21% to 42.2%, (Y) 7.7% to 24.6%, and (W) 8.9% to 22.5%.
RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE
Despite the low incidence of meningococcal disease in the United States, meningococcal disease causes significant morbidity and mortality if not prevented.
CONCLUSION
MenACWY-TT is noninferior to currently approved quadrivalent meningococcal vaccines and shows similar immunogenicity and safety as both an initial vaccine for prevention as well as a booster dose.
Topics: Animals; Clinical Trials, Phase II as Topic; Humans; Incidence; Meningococcal Infections; Meningococcal Vaccines; Randomized Controlled Trials as Topic; Serogroup; Vaccines, Conjugate
PubMed: 34459258
DOI: 10.1177/10600280211039873