Observational Study

. 2024 May 8;14(5):e079144.

doi: 10.1136/bmjopen-2023-079144.

Comprehensive observational study evaluating the enduring effectiveness of 4CMenB, the meningococcal B vaccine against gonococcal infections in the Northern Territory and South Australia, Australia: study protocol

Helen Marshall^{1

2

3}, James Ward⁴, Bing Wang^{5

2

3}, Prabha Andraweera^{5

2

3}, Mark McMillan^{5

2

3}, Louise Flood⁶, Charlotte Bell⁶, Jana Sisnowski⁶, Vicki Krause⁷, Rosalind Webby⁷, Emma Childs⁸, Manoji Gunathilake⁷, Natasha Egoroff⁷, Lex Leong⁹, Andrew Lawrence⁹, Rob Baird¹⁰, Kevin Freeman¹⁰, Dimitrios Menouhos¹⁰, David M Whiley¹¹, Jonathan Karnon¹², Sebastian van Hal^{13

14}, Monica M Lahra^{13

15}

Affiliations

¹ Vaccinology and Immunology Research Trials Unit, Women's and Children's Hospital, Adelaide, South Australia, Australia helen.marshall@adelaide.edu.au.
² Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.
³ Robinson Research Institute, The University of Adelaide, Adelaide, South Australia, Australia.
⁴ Poche Centre, The University of Queensland, Brisbane, Queensland, Australia.
⁵ Vaccinology and Immunology Research Trials Unit, Women's and Children's Hospital, Adelaide, South Australia, Australia.
⁶ Communicable Disease Control Branch, Department for Health and Wellbeing, Government of South Australia, Adelaide, South Australia, Australia.
⁷ Centre for Disease Control & Environmental Health, NT Health, Northern Territory Government, Darwin, Northern Territory, Australia.
⁸ Immunisation and Notifiable Diseases, NT Health, Northern Territory Government, Darwin, Northern Territory, Australia.
⁹ SA Pathology, SA Health, Government of South Australia, Adelaide, South Australia, Australia.
¹⁰ Territory Pathology, NT Health, Northern Territory Government, Darwin, Northern Territory, Australia.
¹¹ UQ Centre for Clinical Research, The University of Queensland and Pathology Queensland, Brisbane, Queensland, Australia.
¹² College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.
¹³ Microbiology, NSW Health Pathology, Sydney, New South Wales, Australia.
¹⁴ The University of Sydney, Sydney, New South Wales, Australia.
¹⁵ The University of New South Wales, Sydney, New South Wales, Australia.

PMID: 38719318
PMCID: PMC11086485
DOI: 10.1136/bmjopen-2023-079144

Observational Study

Comprehensive observational study evaluating the enduring effectiveness of 4CMenB, the meningococcal B vaccine against gonococcal infections in the Northern Territory and South Australia, Australia: study protocol

Helen Marshall et al. BMJ Open. 2024.

. 2024 May 8;14(5):e079144.

doi: 10.1136/bmjopen-2023-079144.

Authors

Affiliations

¹ Vaccinology and Immunology Research Trials Unit, Women's and Children's Hospital, Adelaide, South Australia, Australia helen.marshall@adelaide.edu.au.
² Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.
³ Robinson Research Institute, The University of Adelaide, Adelaide, South Australia, Australia.
⁴ Poche Centre, The University of Queensland, Brisbane, Queensland, Australia.
⁵ Vaccinology and Immunology Research Trials Unit, Women's and Children's Hospital, Adelaide, South Australia, Australia.
⁶ Communicable Disease Control Branch, Department for Health and Wellbeing, Government of South Australia, Adelaide, South Australia, Australia.
⁷ Centre for Disease Control & Environmental Health, NT Health, Northern Territory Government, Darwin, Northern Territory, Australia.
⁸ Immunisation and Notifiable Diseases, NT Health, Northern Territory Government, Darwin, Northern Territory, Australia.
⁹ SA Pathology, SA Health, Government of South Australia, Adelaide, South Australia, Australia.
¹⁰ Territory Pathology, NT Health, Northern Territory Government, Darwin, Northern Territory, Australia.
¹¹ UQ Centre for Clinical Research, The University of Queensland and Pathology Queensland, Brisbane, Queensland, Australia.
¹² College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.
¹³ Microbiology, NSW Health Pathology, Sydney, New South Wales, Australia.
¹⁴ The University of Sydney, Sydney, New South Wales, Australia.
¹⁵ The University of New South Wales, Sydney, New South Wales, Australia.

PMID: 38719318
PMCID: PMC11086485
DOI: 10.1136/bmjopen-2023-079144

Abstract

Introduction: The effectiveness of antibiotics for treating gonococcal infections is compromised due to escalating antibiotic resistance; and the development of an effective gonococcal vaccine has been challenging. Emerging evidence suggests that the licensed meningococcal B (MenB) vaccine, 4CMenB is effective against gonococcal infections due to cross-reacting antibodies and 95% genetic homology between the two bacteria, Neisseria meningitidis and Neisseria gonorrhoeae, that cause the diseases. This project aims to undertake epidemiological and genomic surveillance to evaluate the long-term protection of the 4CMenB vaccine against gonococcal infections in the Northern Territory (NT) and South Australia (SA), and to determine the potential benefit of a booster vaccine doses to provide longer-term protection against gonococcal infections.

Methods and analyses: This observational study will provide long-term evaluation results of the effectiveness of the 4CMenB vaccine against gonococcal infections at 4-7 years post 4CMenB programme implementation. Routine notifiable disease notifications will be the basis for assessing the impact of the vaccine on gonococcal infections. Pathology laboratories will provide data on the number and percentage of N. gonorrhoeae positive tests relative to all tests administered and will coordinate molecular sequencing for isolates. Genome sequencing results will be provided by SA Pathology and Territory Pathology/New South Wales Health Pathology, and linked with notification data by SA Health and NT Health. There are limitations in observational studies including the potential for confounding. Confounders will be analysed separately for each outcome/comparison.

Ethics and dissemination: The protocol and all study documents have been reviewed and approved by the SA Department for Health and Well-being Human Research Ethics Committee (HREC/2022/HRE00308), and the evaluation will commence in the NT on receipt of approval from the NT Health and Menzies School of Health Research Human Research Ethics Committee. Results will be published in peer-reviewed journals and presented at scientific meetings and public forums.

Keywords: Adolescent; Public health; Sexually Transmitted Disease; Vaccination.

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Conflict of interest statement

Competing interests: HM acknowledges support from the National Health and Medical Research Council of Australia: Practitioner Fellowship (APP1155066). HM is an independent investigator on clinical trials of investigational vaccines manufactured by pharmaceutical companies including Pfizer, ILiAD Biotechnologies and Merck. The institution at which HM, BW, MM and PA are employed has received funding for investigator-led research from GlaxoSmithKline, Sanofi-Pasteur and Pfizer Vaccines. All authors receive no personal payments from the industry. There are no other conflicts of interest to declare.

References

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1. Soong TR, Granter SR, Haefner HK, et al. . Chapter 4 - infectious disorders of the lower genital tract. In: Crum CP, Nucci MR, Howitt BE, et al., eds. Diagnostic Gynecologic and Obstetric Pathology. 3rd edn. Philadelphia: Elsevier, 2018: 62–100.
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1. Surveillance update for Notifiable Stis and Bbvs in the NT. Northern Territory Health: Northern Territory: Centre for Disease Control, Public Health Unit-Top End Health Service; 2021.
1. Marshall HS, Andraweera PH, Ward J, et al. . An observational study to assess the effectiveness of 4Cmenb against meningococcal disease and carriage and gonorrhea in adolescents in the Northern territory, Australia-study protocol. Vaccines (Basel) 2022;10:309. 10.3390/vaccines10020309 - DOI - PMC - PubMed

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Comprehensive observational study evaluating the enduring effectiveness of 4CMenB, the meningococcal B vaccine against gonococcal infections in the Northern Territory and South Australia, Australia: study protocol

Affiliations

Comprehensive observational study evaluating the enduring effectiveness of 4CMenB, the meningococcal B vaccine against gonococcal infections in the Northern Territory and South Australia, Australia: study protocol

Authors

Affiliations

Abstract

Conflict of interest statement

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LinkOut - more resources

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Medical

Research Materials