Microbial interactions amongGardnerella,PrevotellaandFannyhesseaprior to incident bacterial vaginosis: protocol for a prospective, observational study

Abstract

IntroductionThe aetiology of bacterial vaginosis (BV), a biofilm-associated vaginal infection, remains unknown. Epidemiologic data suggest that it is sexually transmitted. BV is characterised by loss of lactic acid-producing lactobacilli and an increase in facultative and strict anaerobic bacteria.Gardnerellaspp are present in 95%–100% of cases;Gardnerella vaginalishas been found to be more virulent than other BV-associated bacteria (BVAB) in vitro. However,G. vaginalisis found in women with normal vaginal microbiota and colonisation is not sufficient for BV development. We hypothesise thatGardnerellaspp initiate BV biofilm formation, but incident BV (iBV) requires incorporation of other key BVAB (ie,Prevotella bivia,Fannyhessea vaginae) into the biofilm that alter the transcriptome of the polymicrobial consortium. This study will investigate the sequence of microbiologic events preceding iBV.Methods and analysisThis study will enrol 150 women aged 18–45 years with normal vaginal microbiota and no sexually transmitted infections at a sexual health research clinic in Birmingham, Alabama. Women will self-collect twice daily vaginal specimens up to 60 days. A combination of 16S rRNA gene sequencing, qPCR forGardnerellaspp,P. biviaandF. vaginae, and broad range 16S rRNA gene qPCR will be performed on twice daily vaginal specimens from women with iBV (Nugent score 7–10 on at least 2 consecutive days) and controls (with comparable age, race, contraceptive method and menstrual cycle days) maintaining normal vaginal microbiota to investigate changes in the vaginal microbiota over time for women with iBV. Participants will complete daily diaries on multiple factors including sexual activity.Ethics and disseminationThis protocol is approved by the University of Alabama at Birmingham Institutional Review Board (IRB-300004547) and written informed consent will be obtained from all participants. Findings will be presented at scientific conferences and published in peer-reviewed journals as well as disseminated to providers and patients in communities of interest.