Abstract
INTRODUCTION: 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. METHODS AND ANALYSIS: 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 Lactobacillus crispatus-dominated microbiota, with no evidence of genital inflammation, as assessed by the measurement of inflammatory cytokines. DISCUSSION: Through the establishment of this African vaginal sample biorepository, the intention will be to cultivate Lactobacillus isolates to create a biobank from which to ultimately select geographically diverse Lactobacillus 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. ETHICS AND DISSEMINATION: 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.