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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

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          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.

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          Most cited references36

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          SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

          An-Wen Chan, Jennifer Tetzlaff, Peter C. Gøtzsche … (2014)
          High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.
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            Triangulation in aetiological epidemiology

            Debbie A. Lawlor, Kate Tilling, George Davey Smith (2017)
            Abstract Triangulation is the practice of obtaining more reliable answers to research questions through integrating results from several different approaches, where each approach has different key sources of potential bias that are unrelated to each other. With respect to causal questions in aetiological epidemiology, if the results of different approaches all point to the same conclusion, this strengthens confidence in the finding. This is particularly the case when the key sources of bias of some of the approaches would predict that findings would point in opposite directions if they were due to such biases. Where there are inconsistencies, understanding the key sources of bias of each approach can help to identify what further research is required to address the causal question. The aim of this paper is to illustrate how triangulation might be used to improve causal inference in aetiological epidemiology. We propose a minimum set of criteria for use in triangulation in aetiological epidemiology, summarize the key sources of bias of several approaches and describe how these might be integrated within a triangulation framework. We emphasize the importance of being explicit about the expected direction of bias within each approach, whenever this is possible, and seeking to identify approaches that would be expected to bias the true causal effect in different directions. We also note the importance, when comparing results, of taking account of differences in the duration and timing of exposures. We provide three examples to illustrate these points.
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              Effectiveness of a group B outer membrane vesicle meningococcal vaccine against gonorrhoea in New Zealand: a retrospective case-control study

              Helen Petousis-Harris, Janine Paynter, Jane Morgan … (2017)
              Article 0 comments Cited 88 times – based on 0 reviews     Review now
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                Author and article information

                Journal
                Journal ID (nlm-ta): BMJ Open
                Journal ID (iso-abbrev): BMJ Open
                Journal ID (hwp): bmjopen
                Journal ID (publisher-id): bmjopen
                Title: BMJ Open
                Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                ISSN (Electronic): 2044-6055
                Publication date Collection: 2024
                Publication date (Electronic): 8 May 2024
                Volume: 14
                Issue: 5
                Electronic Location Identifier: e079144
                Affiliations
                [1 ] departmentVaccinology and Immunology Research Trials Unit , Women’s and Children’s Hospital , Adelaide, South Australia, Australia
                [2 ] departmentAdelaide Medical School , The University of Adelaide , Adelaide, South Australia, Australia
                [3 ] departmentRobinson Research Institute , The University of Adelaide , Adelaide, South Australia, Australia
                [4 ] departmentPoche Centre , The University of Queensland , Brisbane, Queensland, Australia
                [5 ] departmentCommunicable Disease Control Branch, Department for Health and Wellbeing , Government of South Australia , Adelaide, South Australia, Australia
                [6 ] departmentCentre for Disease Control & Environmental Health , NT Health, Northern Territory Government , Darwin, Northern Territory, Australia
                [7 ] departmentImmunisation and Notifiable Diseases , NT Health, Northern Territory Government , Darwin, Northern Territory, Australia
                [8 ] departmentSA Pathology , SA Health, Government of South Australia , Adelaide, South Australia, Australia
                [9 ] departmentTerritory Pathology , NT Health, Northern Territory Government , Darwin, Northern Territory, Australia
                [10 ] departmentUQ Centre for Clinical Research , The University of Queensland and Pathology Queensland , Brisbane, Queensland, Australia
                [11 ] departmentCollege of Medicine and Public Health , Flinders University , Adelaide, South Australia, Australia
                [12 ] departmentMicrobiology , NSW Health Pathology , Sydney, New South Wales, Australia
                [13 ] The University of Sydney , Sydney, New South Wales, Australia
                [14 ] The University of New South Wales , Sydney, New South Wales, Australia
                Author notes
                [Correspondence to ] Professor Helen Marshall; helen.marshall@ 123456adelaide.edu.au
                Author information
                http://orcid.org/0000-0003-2521-5166
                http://orcid.org/0000-0002-6490-7707
                Article
                Publisher ID: bmjopen-2023-079144
                DOI: 10.1136/bmjopen-2023-079144
                PMC ID: 11086485
                PubMed ID: 38719318
                SO-VID: 92df7a0b-fb30-4f8c-8c4c-96f1cf874346
                Copyright © © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
                License:

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/.

                History
                Date received : 23 August 2023
                Date accepted : 28 March 2024
                Funding
                Funded by: Northern Territory Department of Health;
                Award ID: Not Applicable
                Funded by: South Australia Department for Health and Wellbeing;
                Award ID: Not Applicable
                Funded by: Health Blood Borne Viruses and Sexually Transmissible Infections Research Program Grant;
                Award ID: GO5055
                Categories
                Subject: Public Health
                Subject: 1506
                Subject: 1724
                Series title: Protocol
                Custom metadata
                special-feature unlocked

                ScienceOpen disciplines: Medicine
                Keywords: sexually transmitted disease,public health,adolescent,vaccination
                Data availability:
                ScienceOpen disciplines: Medicine
                Keywords: sexually transmitted disease, public health, adolescent, vaccination

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