Clinical trial NCT06662747: Vaginal Microbiome Research Consortium for Africa
Official title: Vaginal Microbiome Research Consortium for Africa - Pilot
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy
Lead sponsor: University of Cape Town
Sponsor class: OTHER
Collaborators: name: Desmond Tutu HIV Foundation
name: Kenya Medical Research Institute
First posted: 2024-10-29
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be recruited via the CRS standard recruiting process. Participants will be informed about the study via social media, flyers and posters. Each site will use a variety of recruitment approaches that works best for the local setting.

Recruitment may be conducted through the following possible approaches: community events and mobilisation, partnerships with appropriate programs and via popular social media platforms. Recruitment materials will educate women about HIV, sexual health, and risks in their community, the effectiveness of PrEP for HIV prevention, and the benefits of HIV prevention services. Recruitment will occur over approximately 12 months.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Geographic Insights into Vaginal Microbial Diversity: Characterizing Bacterial and Fungal Community Dynamics in African Women with Stable L. crispatus-Dominated vs. Unstable Microbiota.
timeFrame: 5 years
measure: Explore Vaginal Microbiome Profiles and Their Association with Low Inflammatory States in Women Across Diverse African Geographies.
timeFrame: 3 years
measure: Geographic Variation in HPV Type Prevalence and Divers.
timeFrame: 5 years
measure: Establishment of a Regional Biobank
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: KEMRI
city: Cape Town
country: South Africa
facility: Desmond Tutu Health Foundation
state: Western Cape
Study officials:
affiliation: Research Officer
name: Brian R Kullin, PhD
role: STUDY_DIRECTOR
References: