Evidence map›Paper›PMID 40194532›Full record

Trial reportThe Lancet. Microbe2025

Effect of the vaginal live biotherapeutic LACTIN-V (Lactobacillus crispatus CTV-05) on vaginal microbiota and genital tract inflammation among women at high risk of HIV acquisition in South Africa: a phase 2, randomised, placebo-controlled trial.

Anke Hemmerling, Caroline M Mitchell, Suuba Demby, Musie Ghebremichael, Joseph Elsherbini, Jiawu Xu, Nondumiso Xulu, Johnathan Shih, Krista Dong, Vaneshree Govender and 14 more

Abstract readRandomized Controlled TrialClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Lancet. Microbe, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

23 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Review
  5. Article
  6. HIV Transmission and Immunology of the Male Reproductive Tract.American journal of reproductive immunology (New York, N.Y. : 1989) · 2026
    Review
  7. Review
  8. Fabrication of bioprints self-coated with thermally sensitive lactobacilli for CAUTI applications.European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V · 2026
    Article
  9. Innate Immune Protection Against HIV in the Female Genital Tract.American journal of reproductive immunology (New York, N.Y. : 1989) · 2026
    Review
  10. Review
  11. Review
  12. Article
  13. Article
  14. Review
  15. Review
  16. Review
  17. Review
  18. Review
  19. Review
  20. Disrupted Cervicovaginal Microbiota: Its Role inInternational journal of molecular sciences · 2025
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors.

Anke HemmerlingDepartment of Obstetrics, Gynecology & Reproductive Sciences, University of California San Francisco, San Francisco, CA, USA.
Caroline M MitchellDepartment of Obstetrics & Gynecology, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.
Suuba DembyRagon Institute of Mass General, MIT, and Harvard, Cambridge, MA, USA.
Musie GhebremichaelRagon Institute of Mass General, MIT, and Harvard, Cambridge, MA, USA.
Joseph ElsherbiniRagon Institute of Mass General, MIT, and Harvard, Cambridge, MA, USA.
Jiawu XuRagon Institute of Mass General, MIT, and Harvard, Cambridge, MA, USA.
Nondumiso XuluHIV Pathogenesis Programme, The Doris Duke Medical Research Institute, University of KwaZulu-Natal, Durban, South Africa.
Johnathan ShihRagon Institute of Mass General, MIT, and Harvard, Cambridge, MA, USA.
Krista DongHarvard Medical School, Boston, MA, USA; Ragon Institute of Mass General, MIT, and Harvard, Cambridge, MA, USA; FRESH Clinic South Africa, Umlazi, South Africa.
Vaneshree GovenderAurum Institute, Johannesburg, South Africa.
Vanessa PillayFRESH Clinic South Africa, Umlazi, South Africa.
Nasreen IsmailHIV Pathogenesis Programme, The Doris Duke Medical Research Institute, University of KwaZulu-Natal, Durban, South Africa.
Gardenia CasillasDepartment of Obstetrics, Gynecology & Reproductive Sciences, University of California San Francisco, San Francisco, CA, USA.
Jayajothi MoodleyAurum Institute, Johannesburg, South Africa.
Agnes BergeratDepartment of Obstetrics & Gynecology, Massachusetts General Hospital, Boston, MA, USA.
Tess BrunnerRagon Institute of Mass General, MIT, and Harvard, Cambridge, MA, USA.
Lenine LiebenbergCentre for the AIDS Programme of Research in South Africa, Durban, South Africa; Center for Epidemic Response and Innovation, Stellenbosch University, Stellenbosch, South Africa; School of Laboratory Medicine and Medical Sciences, University of KwaZulu-Natal, Durban, South Africa.
Sinaye NgcapuCentre for the AIDS Programme of Research in South Africa, Durban, South Africa.
Ian MbanoHIV Pathogenesis Programme, The Doris Duke Medical Research Institute, University of KwaZulu-Natal, Durban, South Africa.
Laurel LagenaurOsel, Mountain View, CA, USA.
Thomas P ParksOsel, Mountain View, CA, USA.
Thumbi Ndung'uRagon Institute of Mass General, MIT, and Harvard, Cambridge, MA, USA; HIV Pathogenesis Programme, The Doris Duke Medical Research Institute, University of KwaZulu-Natal, Durban, South Africa.
Douglas S KwonHarvard Medical School, Boston, MA, USA; Ragon Institute of Mass General, MIT, and Harvard, Cambridge, MA, USA. Electronic address: dkwon@mgh.harvard.edu.
Craig R CohenDepartment of Obstetrics, Gynecology & Reproductive Sciences, University of California San Francisco, San Francisco, CA, USA. Electronic address: craig.cohen@ucsf.edu.

Funding

The impact of HIV viral diversity and cellular immunity on HIV pathogenesisP30AI060354 · NIAID · HARVARD UNIVERSITY (MEDICAL SCHOOL) · PI RAJESH T GANDHI · 2004 to 2026
$94.4M
Aurum Clinical Trials UnitUM1AI154463 · NIAID · AURUM INSTITUTE NPC · PI Gavin John Churchyard · 2021 to 2026
$8.1M
Phase 2 placebo-controlled randomized trial of LACTIN-V (Lactobacillus crispatus CTV-05) among women at high risk of HIV acquisition in Durban, South AfricaR01HD098978 · NICHD · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI COHEN, CRAIG R · 2019 to 2022
$3.5M
NIAID NIH HHS P30 AI060354NIAID NIH HHS UM1 AI154463NICHD NIH HHS R01 HD098978
6 · The paper itself

Abstract

backgroundAbsence of vaginal lactobacilli and accompanying genital inflammation is associated with HIV acquisition. We aimed to assess how a vaginal live biotherapeutic containing Lactobacillus crispatus affects cervicovaginal microbiota and markers of HIV susceptibility in South African women.

methodsThis randomised, placebo-controlled, phase 2 trial evaluated LACTIN-V (L crispatus CTV-05), a vaginal live biotherapeutic, compared with placebo in cisgender women in South Africa, aged 18-23 years, recruited at a community-based research clinic. Eligible participants with a Nugent score of 4-10 (indicating intermediate vaginal microbiota or bacterial vaginosis) completed 7 days of oral metronidazole and were randomly assigned (2:1) to LACTIN-V (2 × 10

findings45 Black South African women were randomly assigned to receive LACTIN-V (n=32) or placebo (n=13). One woman in each group discontinued the trial during the intervention and two women discontinued during the follow-up. No severe or serious adverse events were observed. Solicited adverse events occurred in 35 (78%) of 45 participants with no significant difference by group (risk ratio 1·17, 95% CI 0·79-1·75; p=0·44). All local solicited adverse events were mild. 32 (71%) of 45 participants strongly agreed or agreed they would use the product again. L crispatus dominant microbiomes were identified in 13 (41%) of 32 participants in the LACTIN-V group at week 4 and eight (26%) of 31 at week 8, compared with none at week 4 and one (9%) of 11 in week 8 in the placebo group (week 4 p=0·0088; week 8 p=0·40). The proportion of activated endocervical HIV target cells out of total T cells increased from after metronidazole treatment to week 4 in the placebo group (median log

interpretationThe use of LACTIN-V after metronidazole significantly increased vaginal L crispatus colonisation during 4 weeks of use, although this increase was transient, and women in the placebo group had an increase in endocervical CD4

fundingUS National Institute of Child Health and Human Development and US National Institute of Allergy and Infectious Diseases.

Indexed as

HIV InfectionsLactobacillus crispatusMicrobiotaProbioticsVaginaVaginosis, BacterialAdolescentAdultDouble-Blind MethodFemaleHumansMetronidazoleSouth AfricaYoung AdultMetronidazole

Identifiers

PMID40194532
PMCPMC12173475

What OpenQuestion holds

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Registered trials

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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.