DOCSLIB.ORG

Fast Tracking the Vaccine Licensure Process to Control an Epidemic of Serogroup B Meningococcal Disease in New Zealand

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Fast Tracking the Vaccine Licensure Process to Control an Epidemic of Serogroup B Meningococcal Disease in New Zealand INVITED ARTICLE VACCINES Stanley Plotkin, Section Editor Fast Tracking the Vaccine Licensure Process to Control an Epidemic of Serogroup B Meningococcal Disease in New Zealand Diana Lennon,1 Catherine Jackson,1,a Sharon Wong,1,a Maraekura Horsfall,1,a Joanna Stewart,2 and Stewart Reid3,4 1 2 3 4 Community Paediatrics, Epidemiology and Biostatistics, and Immunisation Advisory Center, The University of Auckland, and Ropata Village Medical Centre, Downloaded from Lower Hutt, New Zealand Epidemics of serogroup B meningococcal disease are rare. Strain-specific outer membrane vesicle vaccines, which are not marketed, are the only current tool for control. A correlate of protection is ill defined, but published data suggest that cid.oxfordjournals.org measured serum bactericidal antibody levels parallel efficacy. Even infants can mount a strain-specific antibody response to a strain-specific vaccine. New Zealand’s epidemic (1991–2007; peak rate [in 2001], 17.4 cases per 100,000 persons) was dominated by a single strain. After a 5-year search (1996–2001) for a manufacturer for a strain-specific outer membrane vesicle vaccine, a fast-tracked research program (2002–2004) determined the safety and immunogenicity of vaccine in infants (2 age groups: 6–10 weeks and 6–8 months), children (age, 16–24 months), and school-aged children (age, 8–12 years) after an adult trial. The vaccine was reactogenic, compared with control vaccines (meningococcal C conjugate and routine infant at World Health Organization on March 14, 2011 vaccines), but retention was high. Three vaccine doses produced antibody levels (measured by serum bactericidal assay) that were considered to be adequate for public health intervention. However, in young infants, a fourth dose was required to achieve levels equivalent to those achieved by other age groups. Provisional licensure by New Zealand’s MedSafe was based on serological criteria strengthened by bridged safety data from studies of the parent outer membrane vesicle vaccine, independent assessment of manufacturing quality, and a clear plan for safety monitoring and effectiveness evaluation after licensure. To facilitate the control of an epidemic of single-strain dom- United States and other developed countries and accounts for inated serogroup B meningococcal disease in New Zealand approximately one-half of invasive meningococcal disease in (NZ), licensure of a tailor-made strain-specific outer membrane infants in the United States [1]. Epidemics of serogroup B vesicle (OMV) vaccine was based on serologic criteria alone disease have occurred in many parts of the world [4–7]. with bridged safety data from the parent vaccine without direct Because outbreaks of serogroup B meningococcal disease evidence of efficacy. This is a collation of published data on tend to be clonal, the development of OMV vaccines that target this process. the outbreak strain has been possible. These vaccines are not Neisseria meningitidis is a leading cause of bacterial men- commercially available. ingitis and other invasive bacterial infections worldwide [1–3]. Beginning in 1991 (figure 1), NZ experienced an outbreak Endemic serogroup B meningococcal disease accounts for a of serogroup B disease; 86% of cases (during 1990–2003) were substantial proportion of cases of meningococcal disease in the caused by the B:4:P1.7–2,4 strain [8–10]. Expression of the P1.7–2,4 PorA gene served as a marker of the ST-41/44 clonal complex [10]. Surveillance of meningococcal disease in NZ Received 19 December 2008; accepted 12 April 2009; electronically published 15 July 2009. a Present affiliation: Waitemata District Health Board, Auckland, New Zealand. entails a combination of notification and laboratory data rec- Reprints or correspondence: Dr. Diana Lennon, Community Paediatrics, School of Popula- onciled at the national level [11]. The relative stability of the tion Health, University of Auckland, Private Bag 92019, Auckland, New Zealand (d.lennon@ auckland.ac.nz). epidemic strain PorA protein supported the use of a strain- Clinical Infectious Diseases 2009;49:597–605 specific OMV vaccine for epidemic control [12]. ᮊ 2009 by the Infectious Diseases Society of America. All rights reserved. The epidemic peaked in 2001 (rate of notified disease, 17.4 1058-4838/2009/4904-0017$15.00 DOI: 10.1086/603552 cases per 100,000 persons per year; rate of disease due to the VACCINES • CID 2009:49 (15 August) • 597 Downloaded from Figure 1. Number of cases of meningococcal disease, by serotype and year, in New Zealand during 1990–2008. Notified meningococcal cases includes laboratory-confirmed and probable cases (isolates were tested by polymerase chain reaction starting in 1996). Vaccine coverage (3 doses received) among persons aged 1–19 years was ∼12% in December 2004, ∼77% in December 2005, and ∼83% in December 2006. Serogroups W135, Y, and X are not shown (mean incidence rate during 1998–2008, 8 cases per year). cid.oxfordjournals.org epidemic strain, 10 cases per 100,000 persons per year). Ap- against noncapsular surface antigens [28, 29]. Evidence of in- proximately 80% of cases occurred in persons aged !20 years, volvement of outer membrane proteins (especially PorA) in and ∼50% of cases occurred in persons aged !5 years. The immunity is accumulating [30–32]. However, unlike serogroup rates of disease were higher among indigenous Maori and chil- C meningococcal disease, no clear correlate of protection is dren of Pacific Island descent (both groups were more likely known [33–35]. Studies evaluating age-specific serum bacte- to be socio-economically deprived) than among NZ children ricidal activity in parallel with field efficacy estimates in Brazil at World Health Organization on March 14, 2011 ! of European origin, especially among infants aged 1 year (rates and Chile support the use of serum bactericidal activity as a in 2001: Maori, 429 cases per 100,000 persons per year; Pacific correlate of protection [16, 30, 36]. A landmark Chilean study Island descent, 640 cases per 100,000 persons per year; Euro- involving infants and children that was performed in 1996 dem- pean, 57 cases per 100,000 persons per year [11, 13]. The mean onstrated excellent activity against the strain against which the case fatality rate (during 1991–2003) was 4.1%. infants and children had been vaccinated but had no activity A population-based carriage study was conducted among against other strains [37]. This led to NZ’s decision to use a teenagers in a high-risk area before vaccine administration (in “designer” vaccine to control an epidemic that occurred largely 2004) and after the epidemic had begun to wane. One hundred among young children and that was dominated by a single twenty-three (11%) of 1115 teenagers were carriers of any me- ningococci; 10 (0.9%) of these teenagers carried strain P1.7– strain. The search for a vaccine manufacturer took 6 years 2,4 [14]. There was no carriage study conducted after vaccine (1996–2001). A public-private partnership (2002–2006) was uptake. Studies in Norway and Chile were unable to find an forged between Chiron Vaccines (now Novartis) and the NZ effect of serogroup B outer membrane protein vaccines on Ministry of Health, with technology transfer from the Nor- nasopharyngeal carriage of N. meningitidis [15, 16]. The low wegian Institute of Public Health (NIPH). and unsustained antibody levels with OMV-outer membrane Evaluation of the efficacy of OMV vaccines has been dogged protein vaccines may be less likely to have an effect on naso- with inconsistencies. Efficacy was established in older children pharyngeal carriage, leading to a postulated absence of a herd in 2 randomized controlled trials [5, 38]. Rapid decrease of immunity effect (figures 2–4). vaccine-induced antibody responses in the Norwegian 2-dose trial led to efficacy results of 57% after 29 months [5]. A later VACCINES estimated efficacy of 87% at 10 months suggested potential To date, vaccines evaluated in detail for serogroup B menin- short-term usefulness of this vaccine [39]. To ameliorate the gococcal disease have been outer membrane protein vaccines rapid decrease in antibody levels, a third or fourth dose was [25, 26]. Protection against meningococcal disease has been studied in additional trials [37, 39–42]. The proven efficacy of demonstrated to correlate with bactericidal antibodies [27], but OMV vaccines in children aged !5 years was unclear [6, 7, 36, in serogroup B infections, bactericidal antibodies are directed 38, 43, 44]. 598 • CID 2009:49 (15 August) • VACCINES Table 1. Seroresponders and the Percentage of Participants with a Titer у1:4 to the New Zealand Candidate Vaccine Strain NZ98/ 254 (B:4:P1.7b,4;a Intention-to-Treat Analyses) after Administration of New Zealand Outer Membrane Vesicle (OMV) Vaccine (MeNZB). Age Variable 6–10 weeks 6–8 months 16–24 months 8–12 years (cohort A) 8–12 years (cohort B) No. (%) of seroresponders [95% CI]b After dose 3c 239 (53) [46–59] 163 (74) [68–80] 254 (75) [69–80] 220 (74) [67–79] 230 (79) [73–84] After dose 4d 45 (69) [54–80]d … 42 (100) [90–100]e …… No. (%) of participants with a titer у1:4 [95% CI] After dose 3c 239 (76) [70–81] 202 (92) [88–95] 254 (92.2) [88–95] 224 (92) [88–95] 230 (95) [91–97] After dose 4c 45 (82) [68–91] … 42 (100) [90–100]e …… NOTE. Data are from [17, 18, 20–22]. CI, confidence interval. a Current notation: P1.7–2,4. b Seroresponders were defined as participants who had a у4-fold increase in serum bactericidal antibody titer, compared with prevaccination baseline interpolated titers. A baseline titer of !1:4 was required to reach a titer of у1:8 (seroresponse). c Four to 6 weeks after administration of a vaccine dose. Downloaded from d The fourth dose was given 5 months after dose 3.
Load more

Recommended publications
  • Review Article How the Knowledge of Interactions Between Meningococcus and the Human Immune System Has Been Used to Prepare Effective Neisseria Meningitidis Vaccines
    View metadata, citation and similar papers at core.ac.uk brought to you by CORE provided by Florence Research Hindawi Publishing Corporation Journal of Immunology Research Volume 2015, Article ID 189153, 26 pages http://dx.doi.org/10.1155/2015/189153 Review Article How the Knowledge of Interactions between Meningococcus and the Human Immune System Has Been Used to Prepare Effective Neisseria meningitidis Vaccines R. Gasparini,1 D. Panatto,1 N. L. Bragazzi,1 P. L. Lai,1 A. Bechini,2 M. Levi,2 P. Durando,1 and D. Amicizia1 1 Department of Health Sciences, University ofGenoa,ViaPastore1,16132Genoa,Italy 2Department of Health Sciences, University of Florence, Viale G.B. Morgagni 48, 50134 Florence, Italy Correspondence should be addressed to R. Gasparini; [email protected] Received 21 January 2015; Accepted 9 June 2015 Academic Editor: Nejat K. Egilmez Copyright © 2015 R. Gasparini et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. In the last decades, tremendous advancement in dissecting the mechanisms of pathogenicity of Neisseria meningitidis at a molecular level has been achieved, exploiting converging approaches of different disciplines, ranging from pathology to microbiology, immunology, and omics sciences (such as genomics and proteomics). Here, we review the molecular biology of the infectious agent and, in particular, its interactions with the immune system, focusing on both the innate and the adaptive responses. Meningococci exploit different mechanisms and complex machineries in order to subvert the immune system and to avoid being killed.
    [Show full text]
  • Assessment of Varicella Vaccine for Inclusion in the National Immunisation Schedule, Outcome Management Services: Specialists in Cost Benefit Analysis, Wellington
    Varicella Vaccine Assessment Report 2012 Varicella Vaccination in New Zealand: NHC Assessment 2012 In 2014 the National Health Committee (NHC) received a request for a copy of the NHC’s assessment report on varicella (chicken pox) vaccination. This report was part of early assessment work the NHC undertook in both varicella and rotavirus vaccination in 2011/12, before responsibility for the management and purchasing of vaccines (including considering any changes to the National Immunisation Schedule) transferred from the Ministry of Health to New Zealand’s Pharmaceutical management Agency (PHARMAC). The NHC provided PHARMAC copies of the vaccine assessment reports and recommendations papers in 2013 and formal NHC recommendations on this work were never provided to the Minister of Health. Following the principal of open disclosure the Committee has decided to release the package of NHC vaccination assessments and recommendations on their website (www.nhc.health.govt.nz). National Health Committee Page 1 of 61 Varicella Vaccine Assessment Report 2012 Table of Contents List of Tables ................................................................................................................. 4 Executive Summary ...................................................................................................... 5 Policy Question ............................................................................................................. 6 Who initiated or commissioned the report? ..............................................................
    [Show full text]
  • Immunisation Issues
    Immunisation issues Linda Hill August 2010 Index • Disease control and vaccine effectiveness • The NZ schedule • Vaccines on the horizon • Common Practice Nurse issues • Improving coverage • Vaccine safety surveillance • Recurrent common myths • Recent issues • Communication challenges DISEASE CONTROL AND VACCINE EFFECTIVENESS “Only clean water and antibiotics have had an impact on childhood death and disease that is equal to that of vaccines” World Health Organization 4 Global burden of VPD Hepatitis B Measles 28% 29% Tetanus Polio 10% Hib 0% Pertussis 18% 14% Diphtheria 0% Yellow Fever 1% In 2002, WHO estimated that 1.4 million of deaths among children under 5 years were due to diseases that could have been prevented by routine vaccination. This represents 14% of global total mortality in children under 5 years of age . 5 Smallpox Bangladeshi girl infected with smallpox (1973). POLIO mass immunisation campaigns in 1961 and 1962 and 1961 in campaigns immunisation mass OPV the since Zealand New in poliomyelitis acquired indigenously of cases No Deaths 10 20 30 40 50 60 0 1946 1948 1950 1952 1954 Roll out of vaccine commencing 1956 commencing vaccine of out Roll 1956 1946 Zealand inNew deaths Polio 1958 1960 1962 1964 1966 1968 1970 1972 1974 1976 1978 1980 1982 1984 1986 - 1988 2009 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 Wilson Home for crippled children in Takapuna, Auckland, 1943. Alexander Turnbull Library, Photographer: John Pascoe Reference: 1/4-000643-F 10 Cases 10 20 30 40 50 60 0 1990 1st 3rd 1991 1st 3rd 1992 1st 3rd
    [Show full text]
  • The HPV (Human Papillomavirus) Immunisation Programme
    The HPV (Human Papillomavirus) Immunisation Programme National Implementation Strategic Overview June 2008 HPV Project Team Population Health Directorate Ministry of Health Table of Contents 1. Introduction.............................................................................................4 2. Background ............................................................................................6 Cervical Cancer .............................................................................................6 Human Papillomavirus ...................................................................................9 3. Policy Context to the HPV Immunisation Programme................................11 Cancer Control in New Zealand ...................................................................11 Immunisation ...............................................................................................12 4. HPV Immunisation Programme Purpose, Goals and Objectives.................13 Rationale .....................................................................................................13 Programme Purpose....................................................................................14 Underpinning Principles ...............................................................................14 Programme Goal..........................................................................................14 Programme Objectives.................................................................................14 Implementation Priorities..............................................................................15
    [Show full text]
  • Trends in Vaccine Availability and Novel Vaccine Delivery Technologies: 2008–2025
    Landscape Analysis Trends in vaccine availability and novel vaccine delivery technologies: 2008–2025 July 2008 Bâtiment Avant Centre Phone: 33.450.28.00.49 13 Chemin du Levant Fax: 33.450.28.04.07 01210 Ferney Voltaire www.path.org France www.who.int Landscape Analysis Trends in vaccine availability and novel vaccine delivery technologies: 2008–2025 July 1, 2008 Version: January 22, 2009 ii Table of contents Acronyms and abbreviations.......................................................................................................................................... iv Executive summary......................................................................................................................................................... 1 TRENDS IN VACCINE AVAILABILITY: 2008–2025 ............................................................................................. 2 Choice of vaccine types to be surveyed........................................................................................................................... 2 Vaccine availability and use: 2008–2025........................................................................................................................ 2 Vaccine availability............................................................................................................................................... 2 Delivery strategies................................................................................................................................................. 4 Extensions
    [Show full text]
  • Vaccinology in the Genome Era
    Vaccinology in the genome era C. Daniela Rinaudo, … , Rino Rappuoli, Kate L. Seib J Clin Invest. 2009;119(9):2515-2525. https://doi.org/10.1172/JCI38330. Review Series Vaccination has played a significant role in controlling and eliminating life-threatening infectious diseases throughout the world, and yet currently licensed vaccines represent only the tip of the iceberg in terms of controlling human pathogens. However, as we discuss in this Review, the arrival of the genome era has revolutionized vaccine development and catalyzed a shift from conventional culture-based approaches to genome-based vaccinology. The availability of complete bacterial genomes has led to the development and application of high-throughput analyses that enable rapid targeted identification of novel vaccine antigens. Furthermore, structural vaccinology is emerging as a powerful tool for the rational design or modification of vaccine antigens to improve their immunogenicity and safety. Find the latest version: https://jci.me/38330/pdf Review series Vaccinology in the genome era C. Daniela Rinaudo, John L. Telford, Rino Rappuoli, and Kate L. Seib Novartis Vaccines, Siena, Italy. Vaccination has played a significant role in controlling and eliminating life-threatening infectious diseases through- out the world, and yet currently licensed vaccines represent only the tip of the iceberg in terms of controlling human pathogens. However, as we discuss in this Review, the arrival of the genome era has revolutionized vaccine develop- ment and catalyzed a shift from conventional culture-based approaches to genome-based vaccinology. The availabili- ty of complete bacterial genomes has led to the development and application of high-throughput analyses that enable rapid targeted identification of novel vaccine antigens.
    [Show full text]
  • Understanding Myths and Immunisation a Slice of NZ Narrative
    Understanding myths and immunisation A slice of NZ narrative Helen Petousis‐Harris Immunisation Advisory Centre Dept General Practice and Primary Health Care Sept 2015 Thinking about immunisation myths • What is a myth and for what purpose? • What feeds a myth? • Why do we believe? • Why should we care? • What should we do? New Zealand Herald. 3/9/2015 (yesterday) What is a myth and what purpose does it serve? What is a myth? Myth is ideology in narrative form. • Myths may arise as either • truthful depictions or over‐elaborated accounts of events • as allegory for or personification of natural phenomena, or explanation of ritual. • deliberate deception for personal gain* • They are transmitted to • convey religious or idealised experience • to establish behavioral models, and to teach. • generate business/wealth* • attract attention* *these arise by or are transmitted for pragmatic reasons but rely on the ideology of others Lincoln B. Theorizing Myth. Narrative, Ideology and Scholarship. University of Chicago Press. 1999. Myths provide an explanation Myths provide an explanation Endearing myth ‐ sugar turns kids into little monsters Busted by science since 1994 The need for myth • Helps people make sense of the world • Knowledge is power –basis for improving one’s influence 1978 ‐ current DiFonzo N, Bordia P. Rumor psychology: Social and organizational approaches. American Psychological Association; 2007. It’s innate ‐ leaping to conclusions is easy Post hoc ergo propter hoc ‐ after this, therefore because of this –Noni McDonald’s ‘coincidence
    [Show full text]
  • Adult Vaccination
    +HOW TO TREAT Adult vaccination Adult vaccination receives less attention than the childhood vaccination schedule, and its importance may be overlooked at times. The purpose of this article is to summarise the vaccines recommended for use in adults. It is structured to answer the question “What vaccines should I consider for this patient in front of me?” Understanding iron metabolism helps doctors and patients There is no comprehensive adult vaccination schedule dult vaccination is the poor • the introduction of new antigens cination schedule. The only vaccina- cousin of childhood vaccina- • the introduction of pneumococcal Written by tion visits being recommended are tion. Over the last 30 years, conjugateThe liver vaccine, human papillomavi- Stewart Reid, the visits at age 45 and 65 years for considerable efforts have A rusis (HPV) the main vaccine and rotavirus vaccine. general tetanus-diphtheria (Td) vaccine and gone into refining the childhood vaccina- Also, considerable improvements in practitioner, the annual influenza vaccine from tion schedule, resulting in: coverage“orchestrator” have been made with the help Ropata age 65 years (also for those with spe- • a reduction in the number of visits of theof National iron Immunisation Register, Medical cific medical indications). No effort is in the 1990s a legacyregulation. of the meningococcal group B Centre, made to measure adult immunisation • the greater use of combination vaccination programme (MeNZB). Lower Hutt coverage except for an approximation vaccines since 2000 There is no comprehensive adult vac- Continued on page 2 HOW TO TREAT+Adult vaccination Continued from page 1 of the uptake of the annual influen- CASE VIGNETTE 1 Panel 1 za vaccine.
    [Show full text]
  • The Serogroup B Meningococcal Vaccine Bexsero Elicits Antibodies to Neisseria Gonorrhoeae Evgeny A
    Clinical Infectious Diseases applyparastyle “fig//caption/p[1]” parastyle “FigCapt” MAJOR ARTICLE The Serogroup B Meningococcal Vaccine Bexsero Elicits Antibodies to Neisseria gonorrhoeae Evgeny A. Semchenko,1 Aimee Tan,1 Ray Borrow,2 and Kate L. Seib1, 1 2 Institute for Glycomics, Griffith University, Gold Coast, Queensland, Australia; and Vaccine Evaluation Unit, Public Health England, Manchester Royal Infirmary, United Kingdom Background. Neisseria gonorrhoeae and Neisseria meningitidis are closely-related bacteria that cause a significant global burden of disease. Control of gonorrhoea is becoming increasingly difficult, due to widespread antibiotic resistance. While vaccines are routinely used for N. meningitidis, no vaccine is available for N. gonorrhoeae. Recently, the outer membrane vesicle (OMV) menin- gococcal B vaccine, MeNZB, was reported to be associated with reduced rates of gonorrhoea following a mass vaccination campaign in New Zealand. To probe the basis for this protection, we assessed the cross-reactivity to N. gonorrhoeae of serum raised to the me- ningococcal vaccine Bexsero, which contains the MeNZB OMV component plus 3 recombinant antigens (Neisseria adhesin A, factor H binding protein [fHbp]-GNA2091, and Neisserial heparin binding antigen [NHBA]-GNA1030). Methods. A bioinformatic analysis was performed to assess the similarity of MeNZB OMV and Bexsero antigens to gonococcal proteins. Rabbits were immunized with the OMV component or the 3 recombinant antigens of Bexsero, and Western blots and enzyme-linked immunosorbent assays were used to assess the generation of antibodies recognizing N. gonorrhoeae. Serum from humans immunized with Bexsero was investigated to assess the nature of the anti-gonococcal response. Results. There is a high level of sequence identity between MeNZB OMV and Bexsero OMV antigens, and between the antigens and gonococcal proteins.
    [Show full text]
  • Menzb™ Vaccine Safety Monitoring Plan Is Organised to Provide the DMG with Prompt Reports of Cases of Aes, in Particular Those Involving Hospitalisation
    Meningococcal B Vaccine (MeNZB™) Safety Monitoring Plan Prepared by the Meningococcal Vaccine Strategy Data Management Group 1 June 2004 Table of Contents 1 INTRODUCTION…………………………………………………………………3 2 ROLLOUT ................................................................................................ 4 3 ISMB FORMAL DECISION POINTS ........................................................ 6 3.1 Steps from pilot to countrywide use ............................................ 10 3.1.1 5-19 year olds total cohort for hospital-based monitoring ........ 10 3.1.2 6 week –4 years total cohort for hospital-based monitoring ..... 11 3.1.2.1 16 month – 4 year olds CMDHB cohort .................................... 11 3.1.2.2 6-15 month olds CMDHB cohort ............................................... 12 3.1.2.3 6 week – 5 month olds CMDHB cohort ..................................... 12 3.2 Number of observed events ......................................................... 16 4 DATA SOURCES - DATA FLOWS ........................................................ 16 4.1 Hospital-based monitoring - rare events ..................................... 16 4.2 Hospital-based monitoring of ALL events ................................... 18 4.3 NZPhvC (CARM) – Passive reporting ........................................... 19 4.4 NZPhvC (CARM) Active reporting – IVMP ................................... 19 4.5 Background hospitalisation data ................................................. 20 4.6 Adverse events following routine childhood vaccines .............
    [Show full text]
  • Vaccines Against Meningococcal Diseases
    microorganisms Review Vaccines against Meningococcal Diseases Mariagrazia Pizza 1 , Rafik Bekkat-Berkani 2 and Rino Rappuoli 1,* 1 GSK, 53100 Siena, Italy; [email protected] 2 GSK, Rockville, MD 20850, USA; rafi[email protected] * Correspondence: [email protected]; Tel.: +39-0577-243414 Received: 31 August 2020; Accepted: 1 October 2020; Published: 3 October 2020 Abstract: Neisseria meningitidis is the main cause of meningitis and sepsis, potentially life-threatening conditions. Thanks to advancements in vaccine development, vaccines are now available for five out of six meningococcal disease-causing serogroups (A, B, C, W, and Y). Vaccination programs with monovalent meningococcal serogroup C (MenC) conjugate vaccines in Europe have successfully decreased MenC disease and carriage. The use of a monovalent MenA conjugate vaccine in the African meningitis belt has led to a near elimination of MenA disease. Due to the emergence of non-vaccine serogroups, recommendations have gradually shifted, in many countries, from monovalent conjugate vaccines to quadrivalent MenACWY conjugate vaccines to provide broader protection. Recent real-world effectiveness of broad-coverage, protein-based MenB vaccines has been reassuring. Vaccines are also used to control meningococcal outbreaks. Despite major improvements, meningococcal disease remains a global public health concern. Further research into changing epidemiology is needed. Ongoing efforts are being made to develop next-generation, pentavalent vaccines including a MenACWYX conjugate vaccine and a MenACWY conjugate vaccine combined with MenB, which are expected to contribute to the global control of meningitis. Keywords: Neisseria meningitidis; meningococcal infection; invasive meningococcal disease (IMD); meningococcal outbreaks; meningococcal vaccines; reverse vaccinology; 4CMenB; rLP2086; outer member vesicles (OMV); bactericidal activity 1.
    [Show full text]
  • CARTWRIGHT ANNIVERSARY SEMINAR 5Th August 2008 Presented by Lynda Williams
    CARTWRIGHT ANNIVERSARY SEMINAR 5th August 2008 Presented by Lynda Williams “GARDASIL – CARTWRIGHT’S DAUGHTER?” My involvement in the issue of HPV vaccines formally began on 20 February 2006 when a representative from CSL, the manufacturer of Gardasil, came to meet with members of the Auckland Women’s Health Council and Women’s Health Action. Her visit rang alarm bells. When drug company reps want to come and visit with women’s health groups my alarm bells always start ringing, but this visit was particularly worrying. For a start the young woman couldn’t answer many of the questions we had about the research results. She also made claims about there being a reduction in the timeframe between infection with the human papilloma virus (HPV) and the development of cervical cell abnormalities which she said would be substantiated when new research results were published in 2 – 3 months time – this didn’t happen. And she was obviously hoping that we would support CSL’s endeavours to get the vaccine introduced into the school-based vaccination programme. We made it quite clear that we wouldn’t. We also had major issues around how long the vaccine would last and the need to include males in any anti-HPV vaccination programme. We had other concerns as well and I will come to these later. But before I say any more about Gardasil, we need to go back and set the scene for why this particular issue is the topic of today’s Cartwright lunch time seminar and is one that women’s groups are examining through what we refer to as a “Cartwright lens.” Cervical Cancer Inquiry It is exactly 20 years today since the report of Judge Silvia Cartwright’s Inquiry into the treatment of cervical cancer at National Women’s Hospital was released.
    [Show full text]