HealthyVMRC4AfricaNCT06662747
Vaginal Microbiome Research Consortium for Africa
An observational study of Healthy, run by University of Cape Town at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- None - observational study only
- How many people
- 200 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Oct 2021to 31 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Kenya1 site, 1 recruiting
- Recruiting
KEMRI
Kisumu, Kisumu County, 40100
Serah Gitome, PhD, +254 721 422355, swgitome@gmail.com
Pauline Wekesa, MSc, +254 726 266031, weknasambu@gmail.com
South Africa1 site, 1 recruiting
- Recruiting
Desmond Tutu Health Foundation
Cape Town, Western Cape, 7975
Anda Madikida, +27847588817, Anda.Madikida@hiv-research.org.za
Tanya Pidwell, +27827255159, tanyapidwell@gmail.com
About this study
Official title: Vaginal Microbiome Research Consortium for Africa - Pilot
- 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.
- To identify vaginal communities associated with low levels of inflammation in women from different geographies in Africa
- To examine prevalence and diversity of HPV types circulating in the different geographies and their interaction with the vaginal microbiota
- To create a biobank of stored samples that can be used in future studies and for the isolation of regionally representative bacterial strains.
Read the 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.
- Conditions
- Healthy
- Being tested
- None - observational study only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None - observational study onlyDiagnostic test
No interventions, diagnostics tests for HIV, pregnancy, STIs and BV only
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Cervicovaginal microbiota, mycobiota, and HPV prevalence, and identify women with stable Lactobacillus-dominated microbiota, with no STIs and no evidence of genital inflammation. Receives: Diagnostic Test: None - observational study only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geographic Insights into Vaginal Microbial Diversity: Characterizing Bacterial and Fungal Community Dynamics in African Women with Stable L. crispatus-Dominated vs. Unstable Microbiota.
The study measures the dynamics of vaginal microbial communities (bacterial and fungal) across different African geographies in women with stable L. crispatus-dominant and unstable microbiota. Specific measurements include the recovery of bacterial and fungal DNA through DNA extraction methods. For bacterial profiling, the analysis includes the use of 16S rRNA gene sequencing targeting the V3-V4 variable regions, while fungal diversity, specifically Candida species, is assessed via Internal Transcribed Spacer (ITS) sequencing. The sequencing data is processed using bioinformatics tools such as QIIME2 and DADA2 for quality control, filtering, and taxonomic assignment. Alpha (within-sample) and beta (between-sample) diversity are measured using metrics including the Shannon index and Bray-Curtis dissimilarity. Additionally, multivariate techniques such as NMDS and PCA are employed to visualize community structures and differences.
Measured: 5 years
Explore Vaginal Microbiome Profiles and Their Association with Low Inflammatory States in Women Across Diverse African Geographies.
This study measures vaginal microbial communities associated with low inflammation levels in women across various African geographies. The assessment includes the prevalence of HPV types in different regions, evaluated through statistical tests such as Chi-square and logistic regression to determine geographic variations. The composition of the vaginal microbiota will be analyzed using bioinformatics techniques to report alpha (within-sample) and beta (between-sample) diversity metrics. Significant variations in microbiota profiles across regions will be identified using ANOSIM and PERMANOVA statistical methods. Correlations between specific HPV types and microbiota profiles will be quantified using Spearman or Pearson correlation coefficients to assess their interactions.
Measured: 3 years
Geographic Variation in HPV Type Prevalence and Divers.
This study will measure HPV type prevalence and diversity across various geographies, as well as its interaction with vaginal microbiota. HPV prevalence will be quantified using molecular methods including PCR and next-generation sequencing (NGS) for DNA detection and type analysis. Vaginal microbiota will be profiled by extracting microbial DNA from swabs, followed by 16S rRNA gene sequencing or metagenomics.
The outcome measures include the calculation of HPV prevalence and diversity, utilizing metrics such as the Shannon index. Additional outcome measures involve statistical analysis to characterize relationships between HPV types and microbiota composition, as well as correlation analysis to identify links between specific HPV types and microbial species. This analysis aims to clarify the role of the microbial community in HPV infection and persistence, with a focus on identifying potential protective effects of specific microbiota profiles.
Measured: 5 years
Establishment of a Regional Biobank
Create a biobank of stored samples that can be used in future studies and for the isolation of regionally representative bacterial strains.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start15 Oct 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cape Town
- Sponsor type
- University, hospital or other
- Collaborators
- Desmond Tutu HIV Foundation, Kenya Medical Research Institute
- Responsible party
- Principal investigator, Jo-An Passmore, University of Cape Town
- Investigators
- Brian R Kullin, PhD, Study director, Research Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662747
- Sponsor's protocol ID
- INV-037612
- Acronym
- VMRC4Africa
- Status last verified
- Aug 2025
- First submitted
- 24 Jul 2024
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Microbiome Research Consortium for Africa - Pilot
- ClinicalTrials.gov ID
- NCT06662747
- Acronym / sponsor ID
- VMRC4Africa / INV-037612
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Collaborators
- Desmond Tutu HIV Foundation, Kenya Medical Research Institute
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- To identify vaginal communities associated with low levels of inflammation in women from different geographies in Africa
- To examine prevalence and diversity of HPV types circulating in the different geographies and their interaction with the vaginal microbiota
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Diagnostic Test: None - observational study onlyCervicovaginal microbiota, mycobiota, and HPV prevalence, and identify women with stable Lactobacillus-dominated microbiota, with no STIs and no evidence of genital inflammation. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None - observational study onlyNo interventions, diagnostics tests for HIV, pregnancy, STIs and BV only | Diagnostic test | Healthy |
Primary outcome
Geographic Insights into Vaginal Microbial Diversity: Characterizing Bacterial and Fungal Community Dynamics in African Women with Stable L. crispatus-Dominated vs. Unstable Microbiota.
Time frame: 5 years
The study measures the dynamics of vaginal microbial communities (bacterial and fungal) across different African geographies in women with stable L. crispatus-dominant and unstable microbiota. Specific measurements include the recovery of bacterial and fungal DNA through DNA extraction methods. For bacterial profiling, the analysis includes the use of 16S rRNA gene sequencing targeting the V3-V4 variable regions, while fungal diversity, specifically Candida species, is assessed via Internal Transcribed Spacer (ITS) sequencing. The sequencing data is processed using bioinformatics tools such as QIIME2 and DADA2 for quality control, filtering, and taxonomic assignment. Alpha (within-sample) and beta (between-sample) diversity are measured using metrics including the Shannon index and Bray-Curtis dissimilarity. Additionally, multivariate techniques such as NMDS and PCA are employed to visualize community structures and differences.
Explore Vaginal Microbiome Profiles and Their Association with Low Inflammatory States in Women Across Diverse African Geographies.
Time frame: 3 years
This study measures vaginal microbial communities associated with low inflammation levels in women across various African geographies. The assessment includes the prevalence of HPV types in different regions, evaluated through statistical tests such as Chi-square and logistic regression to determine geographic variations. The composition of the vaginal microbiota will be analyzed using bioinformatics techniques to report alpha (within-sample) and beta (between-sample) diversity metrics. Significant variations in microbiota profiles across regions will be identified using ANOSIM and PERMANOVA statistical methods. Correlations between specific HPV types and microbiota profiles will be quantified using Spearman or Pearson correlation coefficients to assess their interactions.
Geographic Variation in HPV Type Prevalence and Divers.
Time frame: 5 years
This study will measure HPV type prevalence and diversity across various geographies, as well as its interaction with vaginal microbiota. HPV prevalence will be quantified using molecular methods including PCR and next-generation sequencing (NGS) for DNA detection and type analysis. Vaginal microbiota will be profiled by extracting microbial DNA from swabs, followed by 16S rRNA gene sequencing or metagenomics. The outcome measures include the calculation of HPV prevalence and diversity, utilizing metrics such as the Shannon index. Additional outcome measures involve statistical analysis to characterize relationships between HPV types and microbiota composition, as well as correlation analysis to identify links between specific HPV types and microbial species. This analysis aims to clarify the role of the microbial community in HPV infection and persistence, with a focus on identifying potential protective effects of specific microbiota profiles.
Establishment of a Regional Biobank
Time frame: 4 years
Create a biobank of stored samples that can be used in future studies and for the isolation of regionally representative bacterial strains.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brian R Kullin, PhD study director
Research Officer
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by University of Cape Town at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kenya, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jo-Ann S Passmore, PhD (+27 78 421 2701, jo-ann.passmore@uct.ac.za), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geographic Insights into Vaginal Microbial Diversity: Characterizing Bacterial and Fungal Community Dynamics in African Women with Stable L. crispatus-Dominated vs. Unstable Microbiota. (time frame: 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.