Vaginal Microbiome Research Consortium for Africa: study protocol of a multicentre prospective clinical study to evaluate temporal vaginal microbial composition associated with maintenance of reproductive health in women in South Africa and Kenya.

Abstract

The Vaginal Microbiome Research Consortium for Africa (VMRC4Africa) study is a multicentre observational cohort study. We aim to enrol parallel cohorts of 100 women from two sites in two African countries (N=200) (Desmond Tutu HIV Centre [DTHC], South Africa; Kenya Medical Research Institute [KEMRI], Kenya) to evaluate detailed temporal fluctuations in vaginal microbiota in young, generally healthy women from Southern and Eastern Africa. Cohorts in Kenya and South Africa will be followed up twice a week for 10 weeks to create detailed profiles of vaginal microbial community state types (CSTs; by 16S rRNA gene sequencing) and fungal communities (by internal transcribed spacer (ITS) sequencing) and to identify women with stable <i>Lactobacillus crispatus</i>-dominated microbiota, with no evidence of genital inflammation, as assessed by the measurement of inflammatory cytokines. Through the establishment of this African vaginal sample biorepository, the intention will be to cultivate <i>Lactobacillus</i> isolates to create a biobank from which to ultimately select geographically diverse <i>Lactobacillus</i> strains with health-promoting characteristics that can be co-formulated into live biotherapeutic products (LBPs) to treat bacterial vaginosis (BV) for women in sub-Saharan Africa. The VMRC4Africa study has been granted ethical approval by the Human Research Ethics Committees in South Africa (UCT HREC: 611/2022) and Kenya (KEMRI Scientific and Ethics Review Unit: SERU No. 4569). Deidentified microbial community compositional data will be made available on public databases. Results of the study will be published in peer-reviewed journals.