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      Gonococcal vaccines: Public health value and preferred product characteristics; report of a WHO global stakeholder consultation, January 2019

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          Abstract

          Renewed interest in developing vaccines against Neisseria gonorrhoeae has been sparked by the increasing threat of gonococcal antimicrobial resistance (AMR) and growing optimism that gonococcal vaccines are biologically feasible. Evidence suggests serogroup B Neisseria meningitidis vaccines might provide some cross-protection against N. gonorrhoeae, and new gonococcal vaccine candidates based on several approaches are currently in preclinical development. To further stimulate investment and accelerate development of gonococcal vaccines, greater understanding is needed regarding the overall value that gonococcal vaccines might have in addressing public health and societal goals in low-, middle-, and high-income country contexts and how future gonococcal vaccines might be accepted and used, if available. In January 2019, the World Health Organization (WHO) convened a multidisciplinary international group of experts to lay the groundwork for understanding the potential health, economic, and societal value of gonococcal vaccines and their likely acceptance and use, and for developing gonococcal vaccine preferred product characteristics (PPCs). WHO PPCs describe preferences for vaccine attributes that would help optimize vaccine value and use in meeting the global public health need. This paper describes the main discussion points and conclusions from the January 2019 meeting of experts. Participants emphasized the need for vaccines to control N. gonorrhoeae infections with the ultimate goals of preventing adverse sexual and reproductive health outcomes (e.g., infertility) and reducing the impact of gonococcal AMR. Meeting participants also discussed important PPC considerations (e.g., vaccine indications, target populations, and potential immunization strategies) and highlighted crucial research and data needs for guiding the value assessment and PPCs for gonococcal vaccines and advancing gonococcal vaccine development.

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          Antimicrobial resistance in Neisseria gonorrhoeae in the 21st century: past, evolution, and future.

          Neisseria gonorrhoeae is evolving into a superbug with resistance to previously and currently recommended antimicrobials for treatment of gonorrhea, which is a major public health concern globally. Given the global nature of gonorrhea, the high rate of usage of antimicrobials, suboptimal control and monitoring of antimicrobial resistance (AMR) and treatment failures, slow update of treatment guidelines in most geographical settings, and the extraordinary capacity of the gonococci to develop and retain AMR, it is likely that the global problem of gonococcal AMR will worsen in the foreseeable future and that the severe complications of gonorrhea will emerge as a silent epidemic. By understanding the evolution, emergence, and spread of AMR in N. gonorrhoeae, including its molecular and phenotypic mechanisms, resistance to antimicrobials used clinically can be anticipated, future methods for genetic testing for AMR might permit region-specific and tailor-made antimicrobial therapy, and the design of novel antimicrobials to circumvent the resistance problems can be undertaken more rationally. This review focuses on the history and evolution of gonorrhea treatment regimens and emerging resistance to them, on genetic and phenotypic determinants of gonococcal resistance to previously and currently recommended antimicrobials, including biological costs or benefits; and on crucial actions and future advances necessary to detect and treat resistant gonococcal strains and, ultimately, retain gonorrhea as a treatable infection. Copyright © 2014, American Society for Microbiology. All Rights Reserved.
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            Sexually transmitted infections: challenges ahead.

            WHO estimated that nearly 1 million people become infected every day with any of four curable sexually transmitted infections (STIs): chlamydia, gonorrhoea, syphilis, and trichomoniasis. Despite their high global incidence, STIs remain a neglected area of research. In this Commission, we have prioritised five areas that represent particular challenges in STI treatment and control. Chlamydia remains the most commonly diagnosed bacterial STI in high-income countries despite widespread testing recommendations, sensitive and specific non-invasive testing techniques, and cheap effective therapy. We discuss the challenges for chlamydia control and evidence to support a shift from the current focus on infection-based screening to improved management of diagnosed cases and of chlamydial morbidity, such as pelvic inflammatory disease. The emergence and spread of antimicrobial resistance in Neisseria gonorrhoeae is globally recognised. We review current and potential future control and treatment strategies, with a focus on novel antimicrobials. Bacterial vaginosis is the most common vaginal disorder in women, but current treatments are associated with frequent recurrence. Recurrence after treatment might relate to evidence that suggests sexual transmission is integral to the pathogenesis of bacterial vaginosis, which has substantial implications for the development of effective management approaches. STIs disproportionately affect low-income and middle-income countries. We review strategies for case management, focusing on point-of-care tests that hold considerable potential for improving STI control. Lastly, STIs in men who have sex with men have increased since the late 1990s. We discuss the contribution of new biomedical HIV prevention strategies and risk compensation. Overall, this Commission aims to enhance the understanding of some of the key challenges facing the field of STIs, and outlines new approaches to improve the clinical management of STIs and public health.
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              Antimicrobial resistance in Neisseria gonorrhoeae: Global surveillance and a call for international collaborative action

              In a Policy Forum, Teodora Wi and colleagues discuss the challenges of antimicrobial resistance in gonococci.
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                Author and article information

                Contributors
                Journal
                Vaccine
                Vaccine
                Vaccine
                Elsevier Science
                0264-410X
                1873-2518
                09 June 2020
                09 June 2020
                : 38
                : 28
                : 4362-4373
                Affiliations
                [a ]World Health Organization, Geneva, Switzerland
                [b ]Skin and GU Medicine Clinic, Harare, Zimbabwe
                [c ]University of Alabama at Birmingham, Birmingham, AL, USA
                [d ]National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA
                [e ]Centers for Disease Control and Prevention, Atlanta, GA, USA
                [f ]Weill Cornell Medicine-Qatar, Doha, Qatar
                [g ]Chinese Academy of Medical Sciences Institute of Dermatology, Nanjing, China
                [h ]Uniformed Services University of the Health Services, Bethesda, MD, USA
                [i ]University of Bern, Bern, Switzerland
                [j ]Bill and Melinda Gates Foundation, London, UK
                [k ]University of Auckland, Auckland, New Zealand
                [l ]Institute for Glycomics, Griffith University, Gold Coast, Australia
                [m ]Örebro University, Örebro, Sweden
                Author notes
                [* ]Corresponding author. gottliebs@ 123456who.int
                [1]

                Gonococcal Vaccine PPC Expert Advisory Group: Laith Abu-Raddad, Emilie Alirol, Laura Bachmann, Kyle Bernstein, Paul Bloem, Gail Bolan, Nathalie Broutet, Elizabeth Bukusi, Xiang-Sheng Chen, Carolyn Deal, Sinead Delany-Moretlwe, Eileen Dunne, Martin Friede, Pamela Gaspar, Massimo Ghidinelli, Sami L Gottlieb, Lee Harrison, Edward Hook III, Naoko Ishikawa, Ann Jerse, David Kaslow, James Kiarie, Elizabeth Klemm, Ranmini Kularatne, Nicola Low, Calman MacLennan, Otilia Mårdh, Anthony Marfin, Philippe Mayaud, Francis Ndowa, Helen Petousis-Harris, Reshmie Ramautarsing, Gita Ramjee, Michael Russell, Kate Seib, Pachara Sirivongrangson, Michiel Stork, Katy Turner, Magnus Unemo, Johan Vekemans, Leah Vincent, Teodora Wi, Susu Zughaier (all affiliations in Acknowledgements).

                Article
                S0264-410X(20)30317-0
                10.1016/j.vaccine.2020.02.073
                7273195
                32359875
                491a3292-5c9d-4099-ac6a-71f1dc8d5805
                © 2020 World Health Organization

                This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/3.0/).

                History
                : 24 February 2020
                : 25 February 2020
                Categories
                Article

                Infectious disease & Microbiology
                gonorrhea,neisseria gonorrhoeae,vaccines,gonococcal vaccines,sexually transmitted infections

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