Vaginal Microbiome Research Consortium for Africa

Официальное название

Vaginal Microbiome Research Consortium for Africa - Pilot

Обзор

1. To characterise vaginal microbial community dynamics (bacterial and fungal) from different geographies in Africa to understand the microbial diversity that occurs in women with stable L. crispatus-dominant versus unstable vaginal microbiota. 2. To identify vaginal communities associated with low levels of inflammation in women from different geographies in Africa 3. To examine prevalence and diversity of HPV types circulating in the different geographies and their interaction with the vaginal microbiota 4. To create a biobank of stored samples that can be used in future studies and for the isolation of regionally representative bacterial strains.

Подробное описание

This investment forms part of the BMGF Calestous Juma Scientific Leadership (CJSL) Fellowship to Dr Jo-Ann Passmore, to pilot VMRC4Africa and establish a collaborative regional network with African partners and Centres of Excellence with capacity and expertise to conduct clinical trials and vaginal microbiome research in Africa. With this CJSL Fellowship investment, Dr Passmore and her collaborators aim to enrol parallel cohorts of women from two sites in two African countries (South Africa: Desmond Tutu HIV Foundation \[DTHF\] and Kenya Medical Research Institute \[KEMRI\]) to evaluate detailed temporal fluctuations in vaginal microbiota in young, generally healthy women from Southern and Eastern Africa. These parallel cohorts will be intensively followed for 10 weeks, to create detailed profiles of vaginal microbial community state types (CSTs; by 16S rRNA gene sequencing) and fungal communities \[by internal transcribed spacer (ITS) sequencing\], to identify women with stable Lactobacillus-dominated microbiota, with no evidence of genital inflammation. Through the establishment of an "African vaginal microbiome biorepository", the intention will be to create a biobank from which to ultimately select geographically diverse Lactobacillus crispatus strains with health promoting characteristics that can be co-formulated into live biotherapeutic products (LBPs) to treat bacterial vaginosis (BV) for women globally.

Вмешательства

• Диагностический тест None - observational study only
  No interventions, diagnostics tests for HIV, pregnancy, STIs and BV only

Первичные конечные точки

• Geographic Insights into Vaginal Microbial Diversity: Characterizing Bacterial and Fungal Community Dynamics in African Women with Stable L. crispatus-Dominated vs. Unstable Microbiota. [Срок оценки: 5 years]
• Explore Vaginal Microbiome Profiles and Their Association with Low Inflammatory States in Women Across Diverse African Geographies. [Срок оценки: 3 years]
• Geographic Variation in HPV Type Prevalence and Divers. [Срок оценки: 5 years]
• Establishment of a Regional Biobank [Срок оценки: 4 years]

Критерии участия

Критерии включения

• Female at birth
• Willing and able to provide informed consent for screening and cognitive ability to understand sampling procedures
• Not pregnant
• HIV negative on testing performed by study staff
• 18-40 years old
• Planning to stay in the area for the next 10 weeks
• Able and willing to provide adequate locator information for study retention purposes
• Willing and able to return for all 3 nurse visits and return self-swabs to the clinic weekly
• Sexually active for the last 3 months defined as penetrative penile-vaginal intercourse at least once in the last 3 months

Критерии исключения

• Male at birth
• Not willing to provide consent
• Pregnant or actively trying to conceive/become pregnant in the next 10 weeks
• Living with HIV or untreated STIs (CT, NG, TV) or bacterial vaginosis (Nugent > 3)
• Currently taking antibiotics or having been on antibiotic treatment in the previous four weeks
• <18 or >40 years old
• On chronic disease management for gynaecological conditions
• Any medical condition or other factors which would preclude study participation as per principal Investigator's or designee's decision, including but not limited to cancer of the cervix
• Any mental health condition which, in the opinion of the investigator, would preclude comprehension of informed consent, or preclude study participation
• Currently enrolled on any other study prohibiting co-enrolment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Kenya · 1 центр

• KEMRI — Kisumu

ЮАР · 1 центр

• Desmond Tutu Health Foundation — Cape Town

Идентификаторы

NCT: NCT06662747 · INV-037612

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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