Show simple item record

Doxycycline prophylaxis and meningococcal group B vaccine to prevent bacterial sexually transmitted infections in France (ANRS 174 DOXYVAC): a multicentre, open-label, randomised trial with a 2 × 2 factorial design

dc.rights.licenseopenen_US
dc.contributor.authorMOLINA, Jean-Michel
hal.structure.identifierMicrobiologie Fondamentale et Pathogénicité [MFP]
dc.contributor.authorBERCOT, Beatrice
dc.contributor.authorASSOUMOU, Lambert
dc.contributor.authorRUBENSTEIN, Emma
dc.contributor.authorALGARTE-GENIN, Michele
dc.contributor.authorPIALOUX, Gilles
dc.contributor.authorKATLAMA, Christine
dc.contributor.authorSURGERS, Laure
hal.structure.identifierMicrobiologie Fondamentale et Pathogénicité [MFP]
dc.contributor.authorBÉBÉAR, Cécile
dc.contributor.authorDUPIN, Nicolas
dc.contributor.authorOUATTARA, Moussa
dc.contributor.authorSLAMA, Laurence
dc.contributor.authorPAVIE, Juliette
dc.contributor.authorDUVIVIER, Claudine
dc.contributor.authorLOZE, Benedicte
dc.contributor.authorGOLDWIRT, Lauriane
dc.contributor.authorGIBOWSKI, Severine
dc.contributor.authorOLLIVIER, Manon
dc.contributor.authorGHOSN, Jade
dc.contributor.authorCOSTAGLIOLA, Dominique
dc.contributor.authorASLAN, Alexandre
dc.contributor.authorPINTADO, Claire
dc.contributor.authorDELAUGERRE, Constance
dc.contributor.authorPONSCARME, Diane
dc.contributor.authorDALLE, Eve
dc.contributor.authorCHAS, Julie
dc.contributor.authorSIGUIER, Martin
dc.contributor.authorPALICH, Romain
dc.contributor.authorVALENTIN, Marc-Antoine
dc.contributor.authorYAZDANPANAH, Yazdan
dc.contributor.authorLACOMBE, Karine
dc.contributor.authorVIARD, Jean-Paul
dc.contributor.authorLOURENCO, Jeremy
dc.contributor.authorRACHLINE, Anne
dc.contributor.authorDETRUCHIS, Pierre
dc.contributor.authorDIEMER, Myriam
dc.contributor.authorAZEMAR, Laurene
dc.contributor.authorLANDOWSKI, Stephanie
dc.contributor.authorOMETSGUINE, Philippe
dc.contributor.authorBUISSON, Martin
dc.contributor.authorFELIHO, Philip
dc.contributor.authorBACHELARD, Antoine
dc.contributor.authorPHUNG, Bao
dc.contributor.authorRIOUX, Christophe
dc.contributor.authorPROUX, Caroline
dc.contributor.authorLE GAC, Sylvie
dc.contributor.authorSCHNEIDER, Luminita
dc.contributor.authorCHARMAK, Aziza
dc.contributor.authorKTORZA, Nadine
dc.contributor.authorSEANG, Sophie
dc.contributor.authorORRIERE, Thibaut
dc.contributor.authorSELLEM, Baptiste
dc.contributor.authorPALACIOS, Christia
dc.contributor.authorMEBARKI, Soraya
dc.date.accessioned2024-10-30T15:47:13Z
dc.date.available2024-10-30T15:47:13Z
dc.date.issued2024-10-01
dc.identifier.issn1473-3099en_US
dc.identifier.urioai:crossref.org:10.1016/s1473-3099(24)00236-6
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/203016
dc.description.abstractEnBackground: Increased rates of sexually transmitted infections (STIs) are reported among men who have sex with men (MSM) and new interventions are needed. We aimed to assess whether post-exposure prophylaxis (PEP) with doxycycline could reduce the incidence of chlamydia or syphilis (or both) and whether the meningococcal group B vaccine (4CMenB) could reduce the incidence of gonorrhoea in this population. Methods: ANRS 174 DOXYVAC is a multicentre, open-label, randomised trial with a 2 × 2 factorial design conducted at ten hospital sites in Paris, France. Eligible participants were MSM aged 18 years or older, HIV negative, had a history of bacterial STIs within the 12 months before enrolment, and who were already included in the ANRS PREVENIR study (a cohort of MSM using pre-exposure prophylaxis with tenofovir and emtricitabine for HIV prevention). Participants were randomly assigned (2:1) to doxycycline PEP (two pills of 100 mg each orally within 72 h after condomless sex, with no more than three doses of 200 mg per week) or no PEP groups and were also randomly assigned (1:1) to the 4CMenB vaccine (GlaxoSmithKline, Paris, France; two intramuscular injections at enrolment and at 2 months) or no vaccine groups, using a computer-generated randomisation list with a permuted fixed block size of four. Follow-up occurred for at least 12 months (with visits every 3 months) up to 24 months. The coprimary outcomes were the risk of a first episode of chlamydia or syphilis (or both) after the enrolment visit at baseline for the doxycycline intervention and the risk of a first episode of gonorrhoea starting at month 3 (ie, 1 month after the second vaccine dose) for the vaccine intervention, analysed in the modified intention-to-treat population (defined as all randomly assigned participants who had at least one follow-up visit). This trial is registered with ClinicalTrials.gov, NCT04597424 (ongoing). Findings: Between Jan 19, 2021, and Sept 19, 2022, 556 participants were randomly assigned. 545 (98%) participants were included in the modified intention-to-treat analysis for the doxycycline PEP and no PEP groups and 544 (98%) were included for the 4CMenB vaccine and no vaccine groups. The median follow-up was 14 months (IQR 9-18). The median age was 40 years (34-48) and all 545 participants were male. There was no interaction between the two interventions (p≥0·1) for the primary outcome. The incidence of a first episode of chlamydia or syphilis (or both) was 8·8 per 100 person-years (35 events in 362 participants) in the doxycycline PEP group and 53·2 per 100 person-years (80 events in 183 participants) in the no PEP group (adjusted hazard ratio [aHR] 0·17 [95% CI 0·12-0·26]; p<0·0001). The incidence of a first episode of gonorrhoea, starting from month 3 was 58·3 per 100 person-years (103 events in 274 participants) in the 4CmenB vaccine group and 77·1 per 100 person-years (122 events in 270 participants) in the no vaccine group (aHR 0·78 [95% CI 0·60-1·01]; p=0·061). There were no deaths during the study. One drug-related serious adverse event (fixed-drug eruption) occurred in the doxycycline PEP group. Six (2%) participants in the doxycycline group discontinued doxycycline PEP because of gastrointestinal adverse events. Interpretation: Doxycycline PEP strongly reduced the incidence of chlamydia and syphilis in MSM, but we did not show efficacy of the 4CmenB vaccine for gonorrhoea. Doxycycline PEP should be assessed in other populations, such as heterosexual men and women, and its effect on antimicrobial resistance carefully monitored.
dc.language.isoENen_US
dc.sourcecrossref
dc.title.enDoxycycline prophylaxis and meningococcal group B vaccine to prevent bacterial sexually transmitted infections in France (ANRS 174 DOXYVAC): a multicentre, open-label, randomised trial with a 2 × 2 factorial design
dc.typeArticle de revueen_US
dc.identifier.doi10.1016/s1473-3099(24)00236-6en_US
dc.subject.halSciences du Vivant [q-bio]/Microbiologie et Parasitologieen_US
dc.identifier.pubmed38797183en_US
bordeaux.journalThe Lancet Infectious Diseasesen_US
bordeaux.page1093-1104en_US
bordeaux.volume24en_US
bordeaux.hal.laboratoriesMFP (Laboratoire Microbiologie Fondamentale et Pathogénicité) - UMR 5234en_US
bordeaux.issue10en_US
bordeaux.institutionCNRSen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
bordeaux.identifier.funderIDAgence Nationale de Recherches sur le Sida et les Hépatites Viralesen_US
bordeaux.import.sourcedissemin
hal.identifierhal-04760760
hal.version1
hal.date.transferred2024-10-30T15:47:19Z
hal.popularnonen_US
hal.audienceInternationaleen_US
hal.exporttrue
workflow.import.sourcedissemin
dc.rights.ccPas de Licence CCen_US
bordeaux.COinSctx_ver=Z39.88-2004&amp;rft_val_fmt=info:ofi/fmt:kev:mtx:journal&amp;rft.jtitle=The%20Lancet%20Infectious%20Diseases&amp;rft.date=2024-10-01&amp;rft.volume=24&amp;rft.issue=10&amp;rft.spage=1093-1104&amp;rft.epage=1093-1104&amp;rft.eissn=1473-3099&amp;rft.issn=1473-3099&amp;rft.au=MOLINA,%20Jean-Michel&amp;BERCOT,%20Beatrice&amp;ASSOUMOU,%20Lambert&amp;RUBENSTEIN,%20Emma&amp;ALGARTE-GENIN,%20Michele&amp;rft.genre=article


Files in this item

FilesSizeFormatView

There are no files associated with this item.

This item appears in the following Collection(s)

Show simple item record