Kullin Brian Ronald, Gitome Serah, Happel Anna-Ursula, Pidwell Tanya, Lefevre Mellissa, Madikida Anda, Wekesa Pauline, Mahlangu Karabo, Ochieng James, Awili Lydia, Agolla Winnie, Otieno Rhoda, Mutharimi Amos, Ganief Yacoeb, Daniels Rezeen, Chicken Anika, Welp Kirsten, Livingstone Hannah, Swanepoel Caleb, Claassen-Weitz Shantelle, Kanyoka Pride, Ravel Jacques, Humphrys Michael, Bilski Lisa, Mulder Nicola, Bekker Linda-Gail, Gill Katherine, Jaspan Heather, Bukusi Elizabeth Anne, Passmore Jo-Ann Shelley
Department of Pathology, UCT Institute of Infectious Disease and Molecular Medicine, Cape Town, Western Cape, South Africa
Centre for the Aids Programme of Research in South Africa, Durban, KwaZulu-Natal, South Africa.
BMJ Open. 2025 Feb 22;15(2):e090938. doi: 10.1136/bmjopen-2024-090938.
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 -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 isolates to create a biobank from which to ultimately select geographically diverse 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.
非洲阴道微生物群研究联盟（VMRC4Africa）研究是一项多中心观察性队列研究。我们的目标是从两个非洲国家的两个地点招募100名女性的平行队列（N = 200）（南非德斯蒙德·图图艾滋病毒中心[DTHC]；肯尼亚医学研究所在肯尼亚），以评估来自南部和东部非洲的年轻、总体健康女性阴道微生物群的详细时间波动情况。
肯尼亚和南非的队列将每周随访两次，持续10周，以创建阴道微生物群落状态类型（CST；通过16S rRNA基因测序）和真菌群落（通过内部转录间隔区[ITS]测序）的详细概况，并通过炎症细胞因子测量来识别微生物群稳定主导且无生殖器炎症迹象的女性。
通过建立这个非洲阴道样本生物库，我们打算培养分离株以创建一个生物银行，最终从中选择具有促进健康特性的地理上多样化的菌株，这些菌株可以共同配制成活生物治疗产品（LBP），用于治疗撒哈拉以南非洲女性的细菌性阴道病（BV）。
VMRC4Africa研究已获得南非（UCT HREC：6-11/2022）和肯尼亚（KEMRI科学与伦理审查单位：SERU编号4569）的人类研究伦理委员会的伦理批准。经过身份识别去除的微生物群落组成数据将在公共数据库中提供。该研究结果将发表在同行评审期刊上。
