ArticlePloS one2014
Optimizing viable leukocyte sampling from the female genital tract for clinical trials: an international multi-site study.
Article in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06686043 (A Phase 2 Study of HPV L1 Vaccine in Combination With Imiquimod and Metformin in Cervical, Vaginal, and Vulvar Cancers), which is not on this map. Cited by 50 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 2 Study of HPV L1 Vaccine in Combination With Imiquimod and Metformin in Cervical, Vaginal, and Vulvar Cancers
Who cites it
50 citing papers in PubMed, 54 citations in OpenAlex.
- Menstruation is Associated With Cyclical Granulysin Peaks in Vaginal Secretions Despite Stable Expression by Cervicovaginal Immune Cells.American journal of reproductive immunology (New York, N.Y. : 1989) · 2026Article
- T-Cell Biology in the Female Reproductive Tract: Relevance to HIV Infection.American journal of reproductive immunology (New York, N.Y. : 1989) · 2026Review
- Novel Approaches for Investigating Host Responses to HIV Infection in Ex Vivo Human Genital Tissues.American journal of reproductive immunology (New York, N.Y. : 1989) · 2026Review
- Innate Immune Protection Against HIV in the Female Genital Tract.American journal of reproductive immunology (New York, N.Y. : 1989) · 2026Review
- Enumeration, Phenotyping, and Clinical Associations of Tissue-Resident T Cells in the Ecto- and Endocervix of Women Attending a Colposcopy Clinic.American journal of reproductive immunology (New York, N.Y. : 1989) · 2026Article
- UnveilingiScience · 2025Article
- Mucosal tissue NK cells tune their function between optimal anti-pathogen activity and tissue protection.bioRxiv : the preprint server for biology · 2025Article
- A Noninvasive Method to Sample Immune Cells in the Lower Female Genital Tract Using Menstrual Discs.ImmunoHorizons · 2024Article
- Differential expression of HIV target cells CCR5 and α4β7 in tissue resident memory CD4 T cells in endocervix during the menstrual cycle of HIV seronegative women.Frontiers in immunology · 2024Article
- Distinct mucosal and systemic immunological characteristics in transgender women potentially relating to HIV acquisition.JCI insight · 2023Article
- Advances and challenges in studying the tissue-resident T cell compartment in the human female reproductive tract.Immunological reviews · 2023Review
- Article
- Considerations for Choosing Soluble Immune Markers to Determine Safety of Novel Vaginal Products.Frontiers in reproductive health · 2022Review
- Buprenorphine Increases HIV-1 Infection In Vitro but Does Not Reactivate HIV-1 from Latency.Viruses · 2021Article
- Cervicovaginal Tissue Residence Confers a Distinct Differentiation Program upon Memory CD8 T Cells.Journal of immunology (Baltimore, Md. : 1950) · 2021Article
- HIV Pathogenesis in the Human Female Reproductive Tract.Current HIV/AIDS reports · 2021Review
- Characterization of Immune Cells in Oral Tissues of Non-human Primates.Frontiers in oral health · 2021Article
- Betamethasone induces potent immunosuppression and reduces HIV infection in a PBMC in vitro model.Journal of investigative medicine : the official publication of the American Federation for Clinical Research · 2021Article
- OMIP-070: NKp46-Based 27-Color Phenotyping to Define Natural Killer Cells Isolated From Human Tumor Tissues.Cytometry. Part A : the journal of the International Society for Analytical Cytology · 2020Article
- The impact of cervical cytobrush sampling on cervico-vaginal immune parameters and microbiota relevant to HIV susceptibility.Scientific reports · 2020Article
Corrections and comments
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Authors and funding
26 authors at 7 institutions in 4 countries.
Funding
Abstract
backgroundFunctional analysis of mononuclear leukocytes in the female genital mucosa is essential for understanding the immunologic effects of HIV vaccines and microbicides at the site of HIV exposure. However, the best female genital tract sampling technique is unclear. METHODS AND
findingsWe enrolled women from four sites in Africa and the US to compare three genital leukocyte sampling methods: cervicovaginal lavages (CVL), endocervical cytobrushes, and ectocervical biopsies. Absolute yields of mononuclear leukocyte subpopulations were determined by flow cytometric bead-based cell counting. Of the non-invasive sampling types, two combined sequential cytobrushes yielded significantly more viable mononuclear leukocytes than a CVL (p<0.0001). In a subsequent comparison, two cytobrushes yielded as many leukocytes (∼ 10,000) as one biopsy, with macrophages/monocytes being more prominent in cytobrushes and T lymphocytes in biopsies. Sample yields were consistent between sites. In a subgroup analysis, we observed significant reproducibility between replicate same-day biopsies (r = 0.89, p = 0.0123). Visible red blood cells in cytobrushes increased leukocyte yields more than three-fold (p = 0.0078), but did not change their subpopulation profile, indicating that these leukocytes were still largely derived from the mucosa and not peripheral blood. We also confirmed that many CD4(+) T cells in the female genital tract express the α4β7 integrin, an HIV envelope-binding mucosal homing receptor.
conclusionsCVL sampling recovered the lowest number of viable mononuclear leukocytes. Two cervical cytobrushes yielded comparable total numbers of viable leukocytes to one biopsy, but cytobrushes and biopsies were biased toward macrophages and T lymphocytes, respectively. Our study also established the feasibility of obtaining consistent flow cytometric analyses of isolated genital cells from four study sites in the US and Africa. These data represent an important step towards implementing mucosal cell sampling in international clinical trials of HIV prevention.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.