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

BMJ Open. 2025 Feb 22;15(2):e090938. doi: 10.1136/bmjopen-2024-090938.

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.

Keywords: HIV & AIDS; Human Papillomavirus Viruses; IMMUNOLOGY; MICROBIOLOGY; Observational Study.

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Adult
  • Female
  • Humans
  • Kenya
  • Lactobacillus crispatus / genetics
  • Lactobacillus crispatus / isolation & purification
  • Microbiota*
  • Multicenter Studies as Topic
  • Prospective Studies
  • RNA, Ribosomal, 16S / genetics
  • Reproductive Health*
  • South Africa
  • Vagina* / microbiology
  • Young Adult

Substances

  • RNA, Ribosomal, 16S