Vaccine value profile for Neisseria gonorrhoeae

Yiming Lyu¹, Annabelle Choong², Eric P F Chow³, Kate L Seib⁴, Helen S Marshall⁵, Magnus Unemo⁶, Alex de Voux⁷, Bing Wang⁸, Angelica E Miranda⁹, Sami L Gottlieb¹⁰, Maeve B Mello¹¹, Teodora Wi¹², Rachel Baggaley¹³, Caroline Marshall¹⁴, Laith J Abu-Raddad¹⁵, Winston E Abara¹⁶, Xiang-Sheng Chen¹⁷, Jason J Ong¹⁸

Affiliations

¹ University of Melbourne, Parkville, Victoria 3010, Australia. Electronic address: ylyu6@student.unimelb.edu.au.
² Central Clinical School, Faculty of Medicine, Nursing and Health Sciences, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: annabellec@student.unimelb.edu.au.
³ Central Clinical School, Faculty of Medicine, Nursing and Health Sciences, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia; Melbourne Sexual Health Centre, Alfred Health, 580 Swanston Street, Melbourne, Victoria 3053, Australia; Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, 207 Bouverie Street, Melbourne, Victoria 3053, Australia. Electronic address: echow@mshc.org.au.
⁴ Institute for Glycomics, Griffith University, Gold Coast, Queensland 4222, Australia. Electronic address: k.seib@griffith.edu.au.
⁵ The University of Adelaide, Adelaide, South Australia 5005, Australia; Women's and Children's Health Network, North Adelaide, South Australia, Australia. Electronic address: helen.marshall@adelaide.edu.au.
⁶ WHO CC for Gonorrhoea and Other STIs, Örebro University, Örebro, Sweden; Institute for Global Health, University College London (UCL), London, UK. Electronic address: magnus.unemo@regionorebrolan.se.
⁷ Division of Epidemiology and Biostatistics, Faculty of Health Sciences, University of Cape Town, Rondebosch, Cape Town 7700, South Africa. Electronic address: alex.devoux@uct.ac.za.
⁸ The University of Adelaide, Adelaide, South Australia 5005, Australia; Women's and Children's Health Network, North Adelaide, South Australia, Australia. Electronic address: bing.wang@adelaide.edu.au.
⁹ Department of Social Medicine, Universidade Federal do Espirito Santo, Av. Fernando Ferrari, 514 - Goiabeiras, Vitória - ES 29075-910, Brazil. Electronic address: angelica.miranda@ufes.br.
¹⁰ Department of Sexual and Reproductive Health and Research, World Health Organization, Av. Appia 20, 1211 Genève, Switzerland. Electronic address: gottliebs@who.int.
¹¹ Global HIV, Hepatitis and STI Programmes, World Health Organization, Av. Appia 20, 1211 Genève, Switzerland. Electronic address: demellmae@who.int.
¹² Global HIV, Hepatitis and STI Programmes, World Health Organization, Av. Appia 20, 1211 Genève, Switzerland. Electronic address: wit@who.int.
¹³ Global HIV, Hepatitis and STI Programmes, World Health Organization, Av. Appia 20, 1211 Genève, Switzerland. Electronic address: baggaleyr@who.int.
¹⁴ Department of Immunization, Vaccines and Biologicals, World Health Organization, Av. Appia 20, 1211 Genève, Switzerland. Electronic address: cmarshall@who.int.
¹⁵ Weill Cornell Medicine-Qatar, Qatar Foundation - Education City, Box 24144, Doha, Qatar. Electronic address: lja2002@qatar-med.cornell.edu.
¹⁶ Centers for Disease Control and Prevention, 1600 Clifton Road, Atlanta, GA 30329, USA. Electronic address: wabara@cdc.gov.
¹⁷ National Center for STD Control of China CDC, 12 Jiangwangmiao Street, Nanjing 210042, China. Electronic address: chenxs@ncstdlc.org.
¹⁸ Central Clinical School, Faculty of Medicine, Nursing and Health Sciences, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: jason.ong@monash.edu.

PMID: 38123397
PMCID: PMC11169088
DOI: 10.1016/j.vaccine.2023.01.053

Vaccine value profile for Neisseria gonorrhoeae

Yiming Lyu et al. Vaccine. 2024.

. 2024 Jul 25;42(19 Suppl 1):S42-S69.

doi: 10.1016/j.vaccine.2023.01.053. Epub 2023 Dec 13.

Authors

Affiliations

¹ University of Melbourne, Parkville, Victoria 3010, Australia. Electronic address: ylyu6@student.unimelb.edu.au.
² Central Clinical School, Faculty of Medicine, Nursing and Health Sciences, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: annabellec@student.unimelb.edu.au.
³ Central Clinical School, Faculty of Medicine, Nursing and Health Sciences, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia; Melbourne Sexual Health Centre, Alfred Health, 580 Swanston Street, Melbourne, Victoria 3053, Australia; Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, 207 Bouverie Street, Melbourne, Victoria 3053, Australia. Electronic address: echow@mshc.org.au.
⁴ Institute for Glycomics, Griffith University, Gold Coast, Queensland 4222, Australia. Electronic address: k.seib@griffith.edu.au.
⁵ The University of Adelaide, Adelaide, South Australia 5005, Australia; Women's and Children's Health Network, North Adelaide, South Australia, Australia. Electronic address: helen.marshall@adelaide.edu.au.
⁶ WHO CC for Gonorrhoea and Other STIs, Örebro University, Örebro, Sweden; Institute for Global Health, University College London (UCL), London, UK. Electronic address: magnus.unemo@regionorebrolan.se.
⁷ Division of Epidemiology and Biostatistics, Faculty of Health Sciences, University of Cape Town, Rondebosch, Cape Town 7700, South Africa. Electronic address: alex.devoux@uct.ac.za.
⁸ The University of Adelaide, Adelaide, South Australia 5005, Australia; Women's and Children's Health Network, North Adelaide, South Australia, Australia. Electronic address: bing.wang@adelaide.edu.au.
⁹ Department of Social Medicine, Universidade Federal do Espirito Santo, Av. Fernando Ferrari, 514 - Goiabeiras, Vitória - ES 29075-910, Brazil. Electronic address: angelica.miranda@ufes.br.
¹⁰ Department of Sexual and Reproductive Health and Research, World Health Organization, Av. Appia 20, 1211 Genève, Switzerland. Electronic address: gottliebs@who.int.
¹¹ Global HIV, Hepatitis and STI Programmes, World Health Organization, Av. Appia 20, 1211 Genève, Switzerland. Electronic address: demellmae@who.int.
¹² Global HIV, Hepatitis and STI Programmes, World Health Organization, Av. Appia 20, 1211 Genève, Switzerland. Electronic address: wit@who.int.
¹³ Global HIV, Hepatitis and STI Programmes, World Health Organization, Av. Appia 20, 1211 Genève, Switzerland. Electronic address: baggaleyr@who.int.
¹⁴ Department of Immunization, Vaccines and Biologicals, World Health Organization, Av. Appia 20, 1211 Genève, Switzerland. Electronic address: cmarshall@who.int.
¹⁵ Weill Cornell Medicine-Qatar, Qatar Foundation - Education City, Box 24144, Doha, Qatar. Electronic address: lja2002@qatar-med.cornell.edu.
¹⁶ Centers for Disease Control and Prevention, 1600 Clifton Road, Atlanta, GA 30329, USA. Electronic address: wabara@cdc.gov.
¹⁷ National Center for STD Control of China CDC, 12 Jiangwangmiao Street, Nanjing 210042, China. Electronic address: chenxs@ncstdlc.org.
¹⁸ Central Clinical School, Faculty of Medicine, Nursing and Health Sciences, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: jason.ong@monash.edu.

PMID: 38123397
PMCID: PMC11169088
DOI: 10.1016/j.vaccine.2023.01.053

Abstract

Neisseria gonorrhoeae infection (gonorrhoea) is a global public health challenge, causing substantial sexual and reproductive health consequences, such as infertility, pregnancy complications and increased acquisition or transmission of HIV. There is an urgency to controlling gonorrhoea because of increasing antimicrobial resistance to ceftriaxone, the last remaining treatment option, and the potential for gonorrhoea to become untreatable. No licensed gonococcal vaccine is available. Mounting observational evidence suggests that N. meningitidis serogroup B outer membrane vesicle-based vaccines may induce cross-protection against N. gonorrhoeae (estimated 30%-40% effectiveness using the 4CMenB vaccine). Clinical trials to determine the efficacy of the 4CMenB vaccine against N. gonorrhoeae are underway, as are Phase 1/2 studies of a new gonococcal-specific vaccine candidate. Ultimately, a gonococcal vaccine must be accessible, affordable and equitably dispensed, given that those most affected by gonorrhoea are also those who may be most disadvantaged in our societies, and most cases are in less-resourced settings. This vaccine value profile (VVP) provides a high level, holistic assessment of the current data to inform the potential public health, economic and societal value of pipeline vaccines. This was developed by a working group of subject matter experts from academia, non-profit organizations, public private partnerships and multi-lateral organizations. All contributors have extensive expertise on various elements of the N. gonorrhoeae VVP and collectively aimed to identify current research and knowledge gaps. The VVP was developed using published data obtained from peer-reviewed journals or reports.

Keywords: Gonorrhoea; Infertility; Neisseria gonorrhoeae; OMV MenB vaccines; Sexually transmitted infection; Vaccine; Value profile.

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Conflict of interest statement

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: JJO reports financial support from the World Health Organization and Australian National Health and Medical Research Foundation. Some of the authors are present or former staff members of the World Health Organization. The authors alone are responsible for the views expressed in this publication and they do not necessarily represent the views, decisions, or policies of the institutions with which they are affiliated. All other authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

**Fig. 1.**
Overview of candidate vaccines for gonococcal infection in clinical trials.

See this image and copyright information in PMC

References

1. World Health Organization. Global progress report on HIV, viral hepatitis and sexually transmitted infections. https://www.who.int/publications/i/item/9789240027077.
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1. Petousis-Harris H, Paynter J, Morgan J, Saxton P, McArdle B, Goodyear-Smith F, et al. Effectiveness of a group B outer membrane vesicle meningococcal vaccine against gonorrhoea in New Zealand: a retrospective case-control study. Lancet 2017;390(10102):1603–10. - PubMed
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Vaccine value profile for Neisseria gonorrhoeae

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Vaccine value profile for Neisseria gonorrhoeae

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