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

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

Brian Ronald Kullin #  1   2 , Serah Gitome #  3 , Anna-Ursula Happel #  4 , Tanya Pidwell #  4 , Mellissa Lefevre  5 , Anda Madikida  5 , Pauline Wekesa  3 , Karabo Mahlangu  5 , James Ochieng  3 , Lydia Awili  3 , Winnie Agolla  3 , Rhoda Otieno  3 , Amos Mutharimi  3 , Yacoeb Ganief  4 , Rezeen Daniels  5 , Anika Chicken  4   2 , Kirsten Welp  4   2 , Hannah Livingstone  4   2 , Caleb Swanepoel  4   2 , Shantelle Claassen-Weitz  4   2 , Pride Kanyoka  4   2 , Jacques Ravel  6 , Michael Humphrys  6 , Lisa Bilski  6 , Nicola Mulder  7 , Linda-Gail Bekker  5   8 , Katherine Gill  5   9 , Heather Jaspan  4   10   11 , Elizabeth Anne Bukusi  3   12 , Jo-Ann Shelley Passmore  4   2
Affiliations
Observational Study

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

Brian Ronald Kullin et al. BMJ Open. .

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.

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Conflict of interest statement

Competing interests: JR is co-founder of LUCA Biologics, a biotechnology company focusing on translating microbiome research into live biotherapeutics drugs for women’s health. All other authors declare that they have no competing interests.

Figures

Figure 1
Figure 1. Overview of study design. STI, sexually transmitted infection.
See this image and copyright information in PMC

References

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