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However, there is increasing evidence from observational cohort studies that the serogroup B meningococcal vaccine four-component meningitis B vaccine (4CMenB) (Bexsero), licensed to prevent invasive disease caused by\n                      <jats:italic>Neisseria meningitidis<\/jats:italic>\n                      , may provide cross-protection against the closely related bacterium\n                      <jats:italic>N. gonorrhoeae<\/jats:italic>\n                      . This study will evaluate the efficacy of 4CMenB against\n                      <jats:italic>N. gonorrhoeae<\/jats:italic>\n                      infection in men (cis and trans), transwomen and non-binary people who have sex with men (hereafter referred to as GBM+).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>\n                      This is a double-blind, randomised placebo-controlled trial in GBM+, either HIV-negative on pre-exposure prophylaxis against HIV or living with HIV (CD4 count &gt;350\u2009cells\/mm\n                      <jats:sup>3<\/jats:sup>\n                      ), who have had a diagnosis of gonorrhoea or infectious syphilis in the last 18 months (a key characteristic associated with a high risk of\n                      <jats:italic>N. gonorrhoeae<\/jats:italic>\n                      infection). Participants are randomised 1:1 to receive two doses of 4CMenB or placebo 3 months apart. Participants have 3-monthly visits over 24 months, which include testing for\n                      <jats:italic>N. gonorrhoeae<\/jats:italic>\n                      and other sexually transmissible infections, collection of demographics, sexual behaviour risks and antibiotic use, and collection of research samples for analysis of\n                      <jats:italic>N. gonorrhoeae<\/jats:italic>\n                      -specific systemic and mucosal immune responses. The primary outcome is the incidence of the first episode of\n                      <jats:italic>N. gonorrhoeae<\/jats:italic>\n                      infection, as determined by nucleic acid amplification tests, post month 4. Additional outcomes consider the incidence of symptomatic or asymptomatic\n                      <jats:italic>N. gonorrhoeae<\/jats:italic>\n                      infection at different anatomical sites (ie, urogenital, anorectum or oropharynx), incidence by\n                      <jats:italic>N. gonorrhoeae<\/jats:italic>\n                      genotype and antimicrobial resistance phenotype, and level and functional activity of\n                      <jats:italic>N. gonorrhoeae<\/jats:italic>\n                      -specific antibodies.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Ethical approval was obtained from the St Vincent\u2019s Hospital Human Research Ethics Committee, St Vincent\u2019s Hospital Sydney, NSW, Australia (ref: 2020\/ETH01084). Results will be disseminated in peer-reviewed journals and via presentation at national and international conferences.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04415424\">NCT04415424<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2023-081675","type":"journal-article","created":{"date-parts":[[2024,4,16]],"date-time":"2024-04-16T13:31:45Z","timestamp":1713274305000},"page":"e081675","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":15,"title":["Multicentre double-blind randomised placebo-controlled trial evaluating the efficacy of the meningococcal B vaccine, 4CMenB (Bexsero), against\n                    <i>Neisseria gonorrhoeae<\/i>\n                    infection in men who have sex with men: the GoGoVax study protocol"],"prefix":"10.1136","volume":"14","clinical-trial-number":[{"clinical-trial-number":"nct04415424","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct04350138","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7094-3528","authenticated-orcid":false,"given":"Kate L","family":"Seib","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Basil","family":"Donovan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caroline","family":"Thng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David A","family":"Lewis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"McNulty","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher K","family":"Fairley","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barbara","family":"Yeung","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fengyi","family":"Jin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Doug","family":"Fraser","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benjamin R","family":"Bavinton","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew","family":"Law","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcus Y","family":"Chen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric P F","family":"Chow","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David M","family":"Whiley","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brent","family":"Mackie","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael P","family":"Jennings","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5599-7480","authenticated-orcid":false,"given":"Amy V","family":"Jennison","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monica M","family":"Lahra","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3269-1032","authenticated-orcid":false,"given":"Andrew E","family":"Grulich","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2024,4,16]]},"reference":[{"key":"2024041610301795000_14.4.e081675.1","doi-asserted-by":"publisher","DOI":"10.3109\/1040841X.2015.1105782"},{"key":"2024041610301795000_14.4.e081675.2","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(17)30310-9"},{"key":"2024041610301795000_14.4.e081675.3","unstructured":"WHO . 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