Marshall, Helen

Ward, James

Wang, Bing

Andraweera, Prabha

McMillan, Mark

Flood, Louise

Bell, Charlotte

Sisnowski, Jana

Krause, Vicki

Webby, Rosalind

Childs, Emma

Gunathilake, Manoji

Egoroff, Natasha

Leong, Lex

Lawrence, Andrew

Baird, Robert

Freeman, Kevin

Menouhos, Dimitrios

Whiley, David M

Karnon, Jonathan

van Hal, Sebastian

Lahra, Monica M

2024-05-08

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, and 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.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 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.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.

Vaccinology and Immunology Research Trials Unit, Women's and Children's Hospital, Adelaide, South Australia, Australia helen.marshall@adelaide.edu.au.

Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.

Robinson Research Institute, The University of Adelaide, Adelaide, South Australia, Australia.

Poche Centre, The University of Queensland, Brisbane, Queensland, Australia.

Vaccinology and Immunology Research Trials Unit, Women's and Children's Hospital, Adelaide, South Australia, Australia.

Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.

Robinson Research Institute, The University of Adelaide, Adelaide, South Australia, Australia.

Vaccinology and Immunology Research Trials Unit, Women's and Children's Hospital, Adelaide, South Australia, Australia.

Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.

Robinson Research Institute, The University of Adelaide, Adelaide, South Australia, Australia.

Vaccinology and Immunology Research Trials Unit, Women's and Children's Hospital, Adelaide, South Australia, Australia.

Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.

Robinson Research Institute, The University of Adelaide, Adelaide, South Australia, Australia.

Communicable Disease Control Branch, Department for Health and Wellbeing, Government of South Australia, Adelaide, South Australia, Australia.

Communicable Disease Control Branch, Department for Health and Wellbeing, Government of South Australia, Adelaide, South Australia, Australia.

Communicable Disease Control Branch, Department for Health and Wellbeing, Government of South Australia, Adelaide, South Australia, Australia.

Centre for Disease Control & Environmental Health, NT Health, Northern Territory Government, Darwin, Northern Territory, Australia.

Centre for Disease Control & Environmental Health, NT Health, Northern Territory Government, Darwin, Northern Territory, Australia.

Immunisation and Notifiable Diseases, NT Health, Northern Territory Government, Darwin, Northern Territory, Australia.

Centre for Disease Control & Environmental Health, NT Health, Northern Territory Government, Darwin, Northern Territory, Australia.

Centre for Disease Control & Environmental Health, NT Health, Northern Territory Government, Darwin, Northern Territory, Australia.

SA Pathology, SA Health, Government of South Australia, Adelaide, South Australia, Australia.

SA Pathology, SA Health, Government of South Australia, Adelaide, South Australia, Australia.

Territory Pathology, NT Health, Northern Territory Government, Darwin, Northern Territory, Australia.

Territory Pathology, NT Health, Northern Territory Government, Darwin, Northern Territory, Australia.

Territory Pathology, NT Health, Northern Territory Government, Darwin, Northern Territory, Australia.

UQ Centre for Clinical Research, The University of Queensland and Pathology Queensland, Brisbane, Queensland, Australia.

College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.

Microbiology, NSW Health Pathology, Sydney, New South Wales, Australia.

The University of Sydney, Sydney, New South Wales, Australia.

Microbiology, NSW Health Pathology, Sydney, New South Wales, Australia.

The University of New South Wales, Sydney, New South Wales, Australia.

BMJ Open . 2024 May 8;14(5):e079144. doi: 10.1136/bmjopen-2023-079144.

2044-6055

0000-0003-2521-5166

0000-0002-6490-7707

https://pubmed.ncbi.nlm.nih.gov/38719318/?otool=iaurydwlib

https://hdl.handle.net/10137/13328

Adolescent

Public health

Sexually Transmitted Disease

Vaccination

Humans

Gonorrhea

Northern Territory

Meningococcal Vaccines

Neisseria gonorrhoeae

South Australia

Observational Studies as Topic

Female

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.

Journal Article

Publication