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,
Jonathan Karnon,
James Ward,
Mark McMillan,
Andrew Lawrence,
Bing Wang,
Vicki Krause,
David M Whiley,
Rob Baird,
Charlotte Bell,
Monica M Lahra,
Manoji Gunathilake,
Louise Flood,
Prabha Andraweera,
Jana Sisnowski,
Rosalind Webby,
Emma Childs,
Natasha Egoroff,
Lex Leong,
Kevin Freeman,
Dimitrios Menouhos,
Sebastian van Hal
Affiliations
Helen Marshall
2 Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia
Jonathan Karnon
11 College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia
James Ward
4 Poche Centre, The University of Queensland, Brisbane, Queensland, Australia
Mark McMillan
1 Vaccinology and Immunology Research Trials Unit, Women’s and Children’s Hospital, Adelaide, South Australia, Australia
Andrew Lawrence
8 SA Pathology, SA Health, Government of South Australia, Adelaide, South Australia, Australia
Bing Wang
1 Vaccinology and Immunology Research Trials Unit, Women’s and Children’s Hospital, Adelaide, South Australia, Australia
Vicki Krause
6 Centre for Disease Control & Environmental Health, NT Health, Northern Territory Government, Darwin, Northern Territory, Australia
David M Whiley
10 UQ Centre for Clinical Research, The University of Queensland and Pathology Queensland, Brisbane, Queensland, Australia
Rob Baird
9 Territory Pathology, NT Health, Northern Territory Government, Darwin, Northern Territory, Australia
Charlotte Bell
5 Communicable Disease Control Branch, Department for Health and Wellbeing, Government of South Australia, Adelaide, South Australia, Australia
Monica M Lahra
12 Microbiology, NSW Health Pathology, Sydney, New South Wales, Australia
Manoji Gunathilake
6 Centre for Disease Control & Environmental Health, NT Health, Northern Territory Government, Darwin, Northern Territory, Australia
Louise Flood
5 Communicable Disease Control Branch, Department for Health and Wellbeing, Government of South Australia, Adelaide, South Australia, Australia
Prabha Andraweera
1 Vaccinology and Immunology Research Trials Unit, Women’s and Children’s Hospital, Adelaide, South Australia, Australia
Jana Sisnowski
5 Communicable Disease Control Branch, Department for Health and Wellbeing, Government of South Australia, Adelaide, South Australia, Australia
Rosalind Webby
6 Centre for Disease Control & Environmental Health, NT Health, Northern Territory Government, Darwin, Northern Territory, Australia
Emma Childs
7 Immunisation and Notifiable Diseases, NT Health, Northern Territory Government, Darwin, Northern Territory, Australia
Natasha Egoroff
6 Centre for Disease Control & Environmental Health, NT Health, Northern Territory Government, Darwin, Northern Territory, Australia
Lex Leong
8 SA Pathology, SA Health, Government of South Australia, Adelaide, South Australia, Australia
Kevin Freeman
9 Territory Pathology, NT Health, Northern Territory Government, Darwin, Northern Territory, Australia
Dimitrios Menouhos
9 Territory Pathology, NT Health, Northern Territory Government, Darwin, Northern Territory, Australia
Sebastian van Hal
12 Microbiology, NSW Health Pathology, Sydney, New South Wales, Australia
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.
