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The Journal of Adolescent Health :... Sep 2018
Topics: Adolescent; Humans; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis; Tetanus Toxoid
PubMed: 30236995
DOI: 10.1016/j.jadohealth.2018.06.015 -
Expert Review of Vaccines 2015Serogroup A meningococcal epidemics have been a recurrent public health problem, especially in resource-poor countries of Africa. Recently, the administration in mass... (Review)
Review
Serogroup A meningococcal epidemics have been a recurrent public health problem, especially in resource-poor countries of Africa. Recently, the administration in mass vaccination campaigns of a single dose of the monovalent meningococcal conjugate vaccine, MenAfriVac, to the 1-29 year-old population of sub-Saharan Africa has prevented epidemics of meningitis caused by serogroup A Neisseria meningitidis. This strategy has also been shown to provide herd protection of the non-vaccinated population. Development of meningococcal conjugate vaccines covering other serogroups and enhanced use of the pneumococcal and Haemophilus influenzae type b conjugate vaccines must be pursued to fully control bacterial meningitis in sub-Saharan Africa.
Topics: Africa South of the Sahara; Humans; Immunity, Herd; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis, Serogroup A; Vaccines, Conjugate
PubMed: 26358167
DOI: 10.1586/14760584.2015.1084232 -
Expert Review of Vaccines 2023causes invasive meningococcal disease and, globally, significant morbidity, with serogroup B (MenB) being the most common cause of endemic disease and outbreaks in... (Review)
Review
INTRODUCTION
causes invasive meningococcal disease and, globally, significant morbidity, with serogroup B (MenB) being the most common cause of endemic disease and outbreaks in several regions. Extensive use of the four-component serogroup B meningococcal vaccine (4CMenB; Bexsero, GSK) and its inclusion in immunization programs in several countries have generated substantial safety data during the 9 years since its first authorization in 2013.
AREAS COVERED
4CMenB safety data from clinical trials and post-marketing surveillance studies (2011 to 2022), and spontaneously reported adverse events of medical interest from the GSK global safety database. We discuss these safety findings in relation to the benefit of 4CMenB vaccination and implications for further enhancing vaccine confidence.
EXPERT OPINION
4CMenB has been consistently well tolerated across clinical trials and post-licensure surveillance studies, despite a higher incidence of fever reported in infants than with other pediatric vaccines. Surveillance data have not identified any significant safety issues, consistent with an acceptable safety profile of 4CMenB. These findings highlight the need to balance the risk of relatively common, transient, post-immunization fever with the benefit of affording protection that reduces the risk of uncommon but potentially fatal meningococcal infection.
Topics: Infant; Child; Humans; Meningococcal Infections; Meningococcal Vaccines; Serogroup; Neisseria meningitidis, Serogroup B; Neisseria meningitidis
PubMed: 37278390
DOI: 10.1080/14760584.2023.2222015 -
Current Opinion in Infectious Diseases Dec 2019Meningococcal disease is a severe consequence of infection with Neisseria meningitidis, a pathobiont of the pharynx. This organism is panmitic so virulent clones... (Review)
Review
PURPOSE OF REVIEW
Meningococcal disease is a severe consequence of infection with Neisseria meningitidis, a pathobiont of the pharynx. This organism is panmitic so virulent clones transformed with new genetic material can emerge and cause severe outbreaks. The key to sustainable prevention is to restrict carriage of disease-causing strains and thus reduce the chances of transmission between human hosts.
RECENT FINDINGS
Meningococcal population biology has changed recently with emergence of virulent strains linked to a number of sublineages of clonal complex 11. These strains have variously expressed the capsular material of serogroups C and W and caused severe disease in various countries. Glycoconjugate vaccines including quadrivalent (ACWY) and now pentavalent (ACWYX) vaccines are highly immunogenic and prevent disease and carriage due to their respective serogroups. For NmB, new vaccines (4CMenB and MenB-FHbp) containing conserved outer membranes proteins have been deployed and are immunogenic and protective at population level, but clones exist which do not express cognate antigens. In contrast to glycoconjugate vaccines they may not have potent carriage-reducing activity. Mass chemoprophylaxis is gaining credence as an alternative strategy is effective, but has significant shortcomings in sustainability.
SUMMARY
Meningococcal disease is well defined genomically for epidemiological purposes. There is potential for unpredictable emergence of clones that may have reduced susceptibility even to modern vaccines, and continued surveillance and vigilance is necessary. However, tremendous strides have been made in recent years.
Topics: Antigens, Bacterial; Carrier State; Cross Protection; Genetic Variation; Global Health; Host-Pathogen Interactions; Humans; Immunogenicity, Vaccine; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis; Public Health Surveillance; Vaccine Potency
PubMed: 31567569
DOI: 10.1097/QCO.0000000000000606 -
Expert Review of Vaccines May 2017The successful development of two broadly protective vaccines targeting Neisseria meningitidis serogroup B (MenB); 4CMenB and rLP2086, is the most significant recent... (Review)
Review
The successful development of two broadly protective vaccines targeting Neisseria meningitidis serogroup B (MenB); 4CMenB and rLP2086, is the most significant recent advance in meningococcal disease prevention. Areas covered: Here we review the principles underlying the development of each vaccine and the novel methods used to estimate vaccine coverage. We update clinical and post-licensure experience with 4CMenB and rLP2086. Expert commentary: The immunogenicity and acceptable safety profile of 4CMenB and rLP2086 has been demonstrated in clinical trials. Continuing uncertainties exist around the appropriate age groups to be immunized, the degree and duration of efficacy, and the impact on nasopharyngeal carriage which has implications for strategies to interrupt transmission and maximize herd protection effects. Universal vaccination programs such as those undertaken in Quebec and the United Kingdom are providing important information on these issues. The potential for MenB vaccines to prevent infection by other serogroups appears promising, and the impact of MenB vaccines on other pathogenic neisserial species with similar surface proteins warrants further investigation.
Topics: Carrier State; Clinical Trials as Topic; Global Health; Humans; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis, Serogroup B; Product Surveillance, Postmarketing
PubMed: 28375029
DOI: 10.1080/14760584.2017.1308828 -
Glycoconjugate Journal Oct 2021Recent changes in the epidemiology of meningococcal have been reported and meningococcal group W (MenW) has become the third most prevalent group isolated in Brazil in...
Recent changes in the epidemiology of meningococcal have been reported and meningococcal group W (MenW) has become the third most prevalent group isolated in Brazil in the last 10 years. In this study we have developed a conjugate vaccine for MenW using a modified reductive amination conjugation method through a covalent linkage between periodate-oxidized MenW non-O-acetylated polysaccharide and hydrazide-activated monomeric tetanus toxoid. Process control of bulks was done by physicochemical analysis including polysaccharide and protein quantification, high performance liquid chromatography - size exclusion chromatography, capillary electrophoresis, and hydrogen nuclear magnetic resonance. Conjugate bulks were best produced with concentration of polysaccharide twice as high as protein, at room temperature, and pH approximately 6.0. A scaled-up bulk (100 mg scale) was formulated and inoculated intramuscularly in mice in a dose-response study (0.1, 0.5, 1.0 and 10.0 µg of polysaccharide/dose). The immunogenicity of conjugate bulks was determined by serum bactericidal assay and ELISA assays of serum from immunized mice. ELISA and SBA titers revealed high titers of IgG and demonstrated the functionality of the antibodies produced in all doses studied 15 days after the third dose. However, significant differences were observed among them by ELISA. In conclusion, this study established the best conditions to produce MenW conjugate bulks and showed the efficacy of the obtained conjugate bulk in induce a good immune response in mice. Further experiments will need to be done to scale up the conjugation reaction and then allow the use of this conjugate in clinical trials.
Topics: Animals; Antibodies, Bacterial; Blood Bactericidal Activity; Brazil; Female; Glycoconjugates; Humans; Male; Meningococcal Infections; Meningococcal Vaccines; Mice; Neisseria meningitidis; Pilot Projects; Tetanus Toxoid; Vaccines, Conjugate
PubMed: 34515909
DOI: 10.1007/s10719-021-10016-w -
Future Microbiology 2015Neisseria meningitidis serogroup B is the main cause for meningococcal invasive disease in many parts of the world. Since 2013, a new multicomponent vaccine against... (Review)
Review
Neisseria meningitidis serogroup B is the main cause for meningococcal invasive disease in many parts of the world. Since 2013, a new multicomponent vaccine against meningococcal serogroup B (4CMenB) has been licensed in Europe, Australia, Canada, Chile, Uruguay, USA and Brazil with different immunization schedules. Clinical trials involving adults, adolescents, children and infants showed 4CMenB has a good immunogenicity and safety profile. Strain coverage estimates are similar to or better than other recently approved vaccines, ranging from 66% in Canada to 91% in Unites States. Some points still remain to be clarified such as the best immunization strategy, the effect of 4CMenB on carriage, the long-term persistence of protective bactericidal antibodies titers, long-term safety outcomes, the possible emergence of N. meningitidis escape mutants and the vaccine cost-effectiveness. In this review, we focus on the vaccine composition, clinical trials and suggested schedules, safety data, potential strain coverage and future challenges.
Topics: Adolescent; Adult; Antigens, Bacterial; Child; Child, Preschool; Cost-Benefit Analysis; Humans; Immunization Schedule; Infant; Meningitis, Meningococcal; Meningococcal Vaccines; Neisseria meningitidis, Serogroup B; Vaccination; Young Adult
PubMed: 26437903
DOI: 10.2217/fmb.15.91 -
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 -
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 -
Clinical Infectious Diseases : An... Nov 2015A new group A meningococcal conjugate vaccine was developed to eliminate deadly meningitis epidemics in sub-Saharan Africa. (Review)
Review
BACKGROUND
A new group A meningococcal conjugate vaccine was developed to eliminate deadly meningitis epidemics in sub-Saharan Africa.
METHODS
From the outset of the project, advocacy and communication strategies were developed and adjusted as the project evolved in Europe, Africa, India, and the United States. Communications efforts were evidence-based, and involved partnerships with the media and various stakeholders including African ministries of health, the World Health Organization, UNICEF, Gavi, the Centers for Disease Control and Prevention, and Médecins Sans Frontières.
RESULTS
The implementation of an integrated communication strategy ensured the active cooperation of stakeholders while providing an organized and defined format for the dissemination of project-related developmental activities and the successful introduction of the vaccine.
CONCLUSIONS
Early in the project, a communications strategy that engaged stakeholders and potential supporters was developed. The strategy was implemented and adapted as the project matured. Linked communication proved to be key to the successful wide-scale introduction of the PsA-TT (MenAfriVac) vaccine in Africa.
Topics: Africa South of the Sahara; Disease Transmission, Infectious; Europe; Humans; Immunization Programs; India; Interdisciplinary Communication; International Cooperation; Meningitis, Meningococcal; Meningococcal Vaccines; United States; World Health Organization
PubMed: 26553674
DOI: 10.1093/cid/civ493