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Biotechnology Journal Sep 2015Outer membrane vesicles (OMVs) are released spontaneously during growth by many Gram-negative bacteria. They present a range of surface antigens in a native conformation... (Review)
Review
Outer membrane vesicles (OMVs) are released spontaneously during growth by many Gram-negative bacteria. They present a range of surface antigens in a native conformation and have natural properties like immunogenicity, self-adjuvation and uptake by immune cells which make them attractive for application as vaccines against pathogenic bacteria. In particular with Neisseria meningitidis, they have been investigated extensively and an OMV-containing meningococcal vaccine has recently been approved by regulatory agencies. Genetic engineering of the OMV-producing bacteria can be used to improve and expand their usefulness as vaccines. Recent work on meningitis B vaccines shows that OMVs can be modified, such as for lipopolysaccharide reactogenicity, to yield an OMV product that is safe and effective. The overexpression of crucial antigens or simultaneous expression of multiple antigenic variants as well as the expression of heterologous antigens enable expansion of their range of applications. In addition, modifications may increase the yield of OMV production and can be combined with specific production processes to obtain high amounts of well-defined, stable and uniform OMV particle vaccine products. Further improvement can facilitate the development of OMVs as platform vaccine product for multiple applications.
Topics: Animals; Bacterial Outer Membrane Proteins; Biotechnology; Humans; Lipopolysaccharides; Membranes, Artificial; Meningococcal Vaccines; Mice; Nanoparticles; Neisseria meningitidis; Vaccines
PubMed: 26912077
DOI: 10.1002/biot.201400395 -
Expert Review of Vaccines May 2016Adolescents have the highest rates of meningococcal carriage and transmission. Interrupting the adolescent habitat in order to reduce carriage and transmission within... (Review)
Review
Adolescents have the highest rates of meningococcal carriage and transmission. Interrupting the adolescent habitat in order to reduce carriage and transmission within adolescents and to other age groups could help to control meningococcal disease at a population level. Compared to immunization strategies restricted to young children, a strategy focused on adolescents may have more profound and long-lasting indirect impacts, and may be more cost effective. Despite challenges in reaching this age-group, experience with other vaccines show that high vaccine coverage of adolescents is attainable.
Topics: Adolescent; Carrier State; Disease Transmission, Infectious; Humans; Meningitis, Meningococcal; Meningococcal Vaccines; Neisseria meningitidis
PubMed: 26651380
DOI: 10.1586/14760584.2016.1130628 -
Vaccine Jul 2023Real-world studies on vaccine effects are diverse in terms of objectives, study setting and design, data type and scope, and analysis methods. In this review, we... (Review)
Review
BACKGROUND
Real-world studies on vaccine effects are diverse in terms of objectives, study setting and design, data type and scope, and analysis methods. In this review, we describe and discuss four-component meningococcal serogroup B vaccine (4CMenB vaccine, Bexsero) real-world studies with the aim of synthesizing their findings with application of standard methods.
METHODS
We performed a systematic literature review of all real-world studies on 4CMenB vaccine effects on meningococcal serogroup B disease, with no restriction for population age, vaccination schedule and/or type of vaccine effect evaluated (vaccine effectiveness [VE] and vaccine impact [VI] outcomes) published since its licensure in 2013 (from January 2014 until July 2021) in PubMed, Cochrane and the grey literature. We then aimed to synthesize the findings of the identified studies through application of standard synthesis methods.
RESULTS
According to reported criteria we retrieved five studies presenting estimates on 4CMenB vaccine effectiveness and impact. These studies showed great diversity in population, vaccination schedule and analysis methods mainly due to diversity in vaccine strategies and recommendations in the study settings. Directed by this diversity, no quantitative pooling methods to synthesize findings could be applied; instead we descriptively assessed study methods. We report VE estimates ranging from 59% to 94% and VI estimates ranging from 31% to 75%, representing diverse age groups, vaccination schedules and analysis methods.
CONCLUSION
Both vaccine outcomes showed real-life effectiveness of 4CMenB vaccine despite differences in study methodologies and vaccination strategies. Based on appraisal of study methods, we highlighted the need for an adapted tool which facilitates synthesis of heterogenic real-world vaccine studies when quantitative pooling methods are not applicable.
Topics: Humans; Infant; Meningococcal Vaccines; Meningococcal Infections; Serogroup; Neisseria meningitidis, Serogroup B
PubMed: 37321895
DOI: 10.1016/j.vaccine.2023.05.025 -
Medical History Oct 2019Based on a wide range of historical sources, including published scientific literature and archives (Institut Mérieux, WHO and IMTSSA), this article examines the...
Based on a wide range of historical sources, including published scientific literature and archives (Institut Mérieux, WHO and IMTSSA), this article examines the history of the development of the meningococcal A vaccine between 1969 and 1973. It explores the social factors of vaccine development including various collaborations, informal discussions, the circulation of products and materials, formal meetings, trials and setbacks to highlight the complex reality of the development, production and use of the vaccine. Inscribed in a 'Golden Age' of vaccine development and production, this episode not only adds to the scholarship on the history of vaccines, which has tended to focus on a narrative of progress, but also considers the sharing of knowledge through collaborations, and the risks involved in the development of a vaccine. Finally, this perspective reveals the uncertainties and difficulties underlying the production of an effective vaccine.
Topics: History, 20th Century; Humans; International Cooperation; Meningitis, Meningococcal; Meningococcal Vaccines; Polysaccharides, Bacterial; World Health Organization
PubMed: 31571695
DOI: 10.1017/mdh.2019.43 -
Human Vaccines & Immunotherapeutics 2019Meningococcal serogroup B (MenB) is the predominant cause of invasive meningococcal disease in the United States, with older adolescents and young adults attending... (Review)
Review
Meningococcal serogroup B (MenB) is the predominant cause of invasive meningococcal disease in the United States, with older adolescents and young adults attending college at increased risk. Notably, MenB caused all meningococcal disease outbreaks at US colleges between 2011 and 2018. MenB disease is vaccine-preventable. The MenB-FHbp vaccine can be administered on a 2-dose (0 and 6 months) schedule to healthy adolescents and young adults or as a tailored 3-dose (0, 1-2, and 6 months) schedule for individuals at increased risk. This review focuses on the 2-dose schedule (0 and 6 months) of MenB-FHbp. Clinical evidence demonstrating strong and broadly protective immunogenicity in adolescents after primary vaccination, immune persistence up to 48 months post-primary vaccination (18-61% of subjects across schedules), and immune memory evidenced by robust response to a single booster dose are described. Implementation approaches to ensure adolescents and young adults are fully vaccinated against meningococcal disease are discussed.
Topics: Adolescent; Disease Outbreaks; Humans; Immunization Schedule; Immunization, Secondary; Immunogenicity, Vaccine; Immunologic Memory; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis, Serogroup B; Physicians; Practice Guidelines as Topic; United States; Young Adult
PubMed: 30932730
DOI: 10.1080/21645515.2019.1596711 -
MEDICC Review Oct 2019Every year, meningococcal infection by Neisseria meningitidis causes over 500,000 cases and 85,000 deaths in the world, with 20% of survivors suffering sequelae. In Cuba...
Every year, meningococcal infection by Neisseria meningitidis causes over 500,000 cases and 85,000 deaths in the world, with 20% of survivors suffering sequelae. In Cuba its incidence in 1980 reached 5.9 cases per 100,000 population; about 80% of cases were serogroup B, prompting health authorities to declare meningococcal disease the country's main public health problem. Several provinces reported over 120 cases per 100,000 children aged < 1 year, overwhelmingly serogroup B. At that time, no vaccines existed with proven efficacy against N. meningitidis serogroup B, nor was there a vaccine candidate that could be successful in the short term. By 1989, researchers in Havana had developed a Cuban meningococcal B and C vaccine, VA-MENGOC-BC, the world's first against serogroup B meningococcal disease. Its efficacy of 83% was demonstrated in a prospective, randomized, double-blind, placebo-controlled field study. Vaccine production used vesicle or proteoliposome technology for the first time. The same year, the World Intellectual Property Organization awarded its gold medal to the main authors of the VA-MENGOC-BC patent. The vaccine was used in a mass vaccination campaign and later included in Cuba's National Immunization Program, with a cumulative impact on incidence of serogroup B meningococcal disease greater than 95% (93%-98%). Mass, systematic vaccination shifted the spectrum of meningococcal strains in healthy asymptomatic carriers and strains circulating among population groups toward nonvirulent phenotypes. The disease ceased to be a public health problem in the country. VA-MENGOC-BC is the most widely applied vaccine against serogroup B meningococcal disease in the world. Over 60 million doses have been administered in Latin America. In several countries where it has been applied, in which strains other than the vaccine-targeted strains circulate, VA-MENGOC-BC has demonstrated effectiveness against all (55%-98% in children aged < = 4 years and 73%-100% in children aged > 4 years). The vaccine and its proteoliposome technology have had an impact and continue to have potential, not only for meningococcal disease, but also for development of other vaccines and adjuvants.KEYWORDS Neisseria meningitidis, meningococcal disease, meningo-coccal vaccine, biotechnology, pharmaceutical industry, bacterial menin-gitis, meningococcal meningitis, immunization, vaccination, Cuba.
Topics: Adjuvants, Pharmaceutic; Adolescent; Child; Cuba; Drug Development; History, 20th Century; History, 21st Century; Humans; Hypergammaglobulinemia; Meningococcal Infections; Meningococcal Vaccines
PubMed: 32335565
DOI: 10.37757/MR2019.V21.N4.4 -
American Journal of Preventive Medicine Apr 2022A total of 3 vaccines are recommended for U.S. adolescents: tetanus, diphtheria, and acellular pertussis; meningococcal conjugate; and human papillomavirus. To...
INTRODUCTION
A total of 3 vaccines are recommended for U.S. adolescents: tetanus, diphtheria, and acellular pertussis; meningococcal conjugate; and human papillomavirus. To understand the disparities in vaccine availability and hesitancy, adolescent-, household-, and area-level characteristics associated with patterns of vaccine coverage are described.
METHODS
In 2020-2021, the authors generated national estimates among 8 possible combinations of vaccine coverage and identified the associated characteristics using 2015-2017 National Immunization Survey-Teen for male and female adolescents aged 13-17 years (N=63,299) linked to area (ZIP code) characteristics. Next, the factors associated with a missed opportunity for human papillomavirus vaccine (i.e., receipt of tetanus, diphtheria, and acellular pertussis and meningococcal conjugate only compared with coverage of all the 3 vaccines) were identified using logistic regression.
RESULTS
Most U.S. adolescents received all the 3 vaccines (42.9%) or tetanus, diphtheria, and acellular pertussis and meningococcal conjugate only (32.1%); fewer received no vaccines (7.7%) or tetanus, diphtheria, and acellular pertussis only (6.6%); and the remainder received some combination of 1-2 vaccines. Missed opportunities for human papillomavirus vaccination were more likely among adolescents who were male, were of White race, were uninsured, were in middle-income households, and were living in rural areas and were less likely among adolescents who were older, who were Medicaid insured, whose parents completed surveys in Spanish, who were in poverty-level households, and who were living in high-poverty areas.
CONCLUSIONS
A substantial number of U.S. adolescents are not fully vaccinated, and coverage varies by vaccine type, population, and place. Providers should routinely stock all the 3 vaccines and promote simultaneous, same-day vaccination to avoid missed vaccine opportunities. More research and interventions are needed to understand and modify patient, provider, payer, vaccine supply/storage, or other reasons for suboptimal coverage of all the recommended vaccines.
Topics: Adolescent; Diphtheria-Tetanus-acellular Pertussis Vaccines; Female; Humans; Immunization Schedule; Male; Medically Uninsured; Meningococcal Vaccines; Papillomavirus Infections; Papillomavirus Vaccines; United States; Vaccination
PubMed: 35125272
DOI: 10.1016/j.amepre.2021.10.014 -
The Journal of Infection Jul 2017The Global Meningococcal Initiative (GMI) has recently considered current issues in Middle Eastern and African countries, and produced two recommendations: (i) that... (Review)
Review
The Global Meningococcal Initiative (GMI) has recently considered current issues in Middle Eastern and African countries, and produced two recommendations: (i) that vaccination of attendees should be considered for some types of mass-gathering events, as some countries mandate for the Hajj, and (ii) vaccination of people with human immunodeficiency virus should be used routinely, because of increased meningococcal disease (MD) risk. Differences exist between Middle Eastern and African countries regarding case and syndrome definitions, surveillance, and epidemiologic data gaps. Sentinel surveillance provides an overview of trends and prevalence of different capsular groups supporting vaccine selection and planning, whereas cost-effectiveness decisions require comprehensive disease burden data, ideally counting every case. Surveillance data showed importance of serogroup B MD in North Africa and serogroup W expansion in Turkey and South Africa. Success of MenAfriVac in the African "meningitis belt" was reviewed; the GMI believes similar benefits may follow development of a low-cost meningococcal pentavalent vaccine, currently in phase 1 clinical trial, by 2022. The importance of carriage and herd protection for controlling invasive MD and the importance of advocacy and awareness campaigns were also highlighted.
Topics: Africa South of the Sahara; Africa, Northern; Disease Outbreaks; Humans; Immunization Programs; Meningitis, Meningococcal; Meningococcal Infections; Meningococcal Vaccines; Middle East; Neisseria meningitidis; Serogroup; Turkey; Vaccination
PubMed: 28455205
DOI: 10.1016/j.jinf.2017.04.007 -
BMC Public Health May 2023Men who have sex with men (MSM) have suboptimal uptake of human papillomavirus (HPV) and meningococcal vaccines. This study examines barriers and facilitators to HPV and...
BACKGROUND
Men who have sex with men (MSM) have suboptimal uptake of human papillomavirus (HPV) and meningococcal vaccines. This study examines barriers and facilitators to HPV and meningococcal vaccination among MSM in a large, racially/ethnically diverse, and medically underserved U.S. region.
METHODS
In 2020, we conducted five focus groups with MSM living in the Inland Empire, California. Participants discussed (1) their knowledge about and attitudes toward HPV, meningococcal disease, and related vaccines; and (2) factors that would encourage or discourage vaccine uptake. Data were systematically analyzed to identify salient barriers and facilitators to vaccination.
RESULTS
Participants (N = 25) had a median age of 29. Most were Hispanic (68%), self-identified as gay (84%), and had college degrees (64%). Key barriers to vaccination included: (1) limited awareness and knowledge about HPV and meningococcal disease, (2) reliance on mainstream healthcare providers for vaccine information, (3) stigma and reluctance to disclose sexual orientation, (4) uncertainty about health insurance coverage and vaccine costs, and (5) distance and time required to access vaccines. Key facilitators to vaccination were: (1) vaccine confidence, (2) perceived severity of HPV and meningococcal disease, (3) bundling vaccination into routine healthcare, and (4) pharmacies as vaccination sites.
CONCLUSIONS
Findings highlight opportunities for HPV and meningococcal vaccine promotion, including targeted education and awareness campaigns for MSM, LGBT inclusivity training for healthcare providers, and structural interventions to improve vaccine accessibility.
Topics: Humans; Male; Homosexuality, Male; Meningococcal Vaccines; Papillomavirus Infections; Human Papillomavirus Viruses; Focus Groups; Qualitative Research; Health Knowledge, Attitudes, Practice; Social Stigma; Health Services Accessibility; United States; Adult; Middle Aged; Insurance, Health
PubMed: 37221575
DOI: 10.1186/s12889-023-15847-w -
Clinical Infectious Diseases : An... Nov 2015In 2002, the Meningitis Vaccine Project (MVP) chose the Serum Institute of India, Ltd (SIIL), as its manufacturing partner to establish a product development partnership... (Review)
Review
Challenges and Opportunities While Developing a Group A Meningococcal Conjugate Vaccine Within a Product Development Partnership: A Manufacturer's Perspective From the Serum Institute of India.
BACKGROUND
In 2002, the Meningitis Vaccine Project (MVP) chose the Serum Institute of India, Ltd (SIIL), as its manufacturing partner to establish a product development partnership (PDP) with the Meningitis Vaccine Project (MVP). MVP was a collaboration between PATH and the World Health Organization (WHO) to develop meningococcal conjugate vaccines for sub-Saharan Africa.
METHOD
From the outset, SIIL recognized that a partnership with MVP carried some risk but also offered important opportunities for accessing new conjugate vaccine technology and know-how. Over 3 years, SIIL successfully accepted technology transfer for the group A meningococcal polysaccharide from SynCo Bio Partners and a conjugation method from the US Food and Drug Administration.
RESULTS
SIIL successfully scaled up production of a group A meningococcal conjugate vaccine that used SIIL tetanus toxoid as the carrier protein. Phase 1 studies began in India in 2005, followed by phase 2/3 studies in Africa and India. A regulatory dossier was submitted to the Indian authorities in April 2009 and WHO in September 2009. Export license was granted in December 2009, and WHO prequalification was obtained in June 2010. Vaccine was introduced at public scale in Burkina Faso that December. The group A meningococcal conjugate vaccine was named MenAfriVac, and is the first internationally qualified vaccine developed outside of big pharma.
CONCLUSIONS
The project proved to be a sound investment for SIIL and is a concrete example of the potential for PDPs to provide needed products for resource-poor countries.
Topics: Humans; India; International Cooperation; Meningococcal Vaccines; Technology Transfer; Technology, Pharmaceutical; World Health Organization
PubMed: 26553678
DOI: 10.1093/cid/civ500