Evidence map›Paper›PMID 26118476›Full record

Trial reportAmerican journal of reproductive immunology (New York, N.Y. : 1989)2015

Soluble Immune Mediators and Vaginal Bacteria Impact Innate Genital Mucosal Antimicrobial Activity in Young Women.

Rebecca Pellett Madan, Charlene S Dezzutti, Lorna Rabe, Sharon L Hillier, Jeanne Marrazzo, Ian McGowan, Barbra A Richardson, Betsy C Herold, Microbicide Trials Network Biomedical Sciences working Group and the MTN 004 Protocol Team

Open access · bronzeAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in American journal of reproductive immunology (New York, N.Y. : 1989), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
0.7field-weighted citation impact, top 29% of its field
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

12 citing papers in PubMed, 19 citations in OpenAlex.

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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

9 authors at 4 institutions in 1 country.

Rebecca Pellett MadanDepartment of Pediatrics, Albert Einstein College of Medicine, Bronx, NY, USA.
Charlene S DezzuttiMagee-Womens Research Institute, Pittsburgh, PA, USA.
Lorna RabeMagee-Womens Research Institute, Pittsburgh, PA, USA.
Sharon L HillierMagee-Womens Research Institute, Pittsburgh, PA, USA.
Jeanne MarrazzoDepartment of Medicine, University of Washington, Seattle, WA, USA.
Ian McGowanMagee-Womens Research Institute, Pittsburgh, PA, USA.
Barbra A RichardsonDepartments of Biostatistics and Global Health, University of Washington, Seattle, WA, USA.
Betsy C HeroldDepartment of Pediatrics, Albert Einstein College of Medicine, Bronx, NY, USA.
Microbicide Trials Network Biomedical Sciences working Group and the MTN 004 Protocol Team
Albert Einstein College of Medicine · USMagee-Womens Research Institute · USUniversity of Pittsburgh · USUniversity of Washington · US

Funding

Microbicide Trials NetworkUM1AI068633 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI HILLIER, SHARON L. · 2011 to 2021
$175.0M
Statistical and Data Management Center (SDMC): Microbicide Trials NetworkUM1AI068615 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI BROWN, ELIZABETH RENATA · 2011 to 2021
$66.5M
University of Pittsburgh Clinical and Translational Science InstituteUL1TR000005 · NCATS · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2012 to 2015
$50.8M
Laboratory Center (LC): Microbicide Trials NetworkUM1AI106707 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI MELLORS, JOHN W, ROHAN, LISA CENCIA · 2014 to 2021
$27.1M
Core-010UL1TR001073 · NCATS · ALBERT EINSTEIN COLLEGE OF MEDICINE, INC · PI KELLER, MARLA J, SHAMOON, HARRY · 2013 to 2017
$21.3M
Genital Mucosal Immunity in Adolescent WomenK23AI089271 · NIAID · ALBERT EINSTEIN COLLEGE OF MEDICINE, INC · PI MADAN, REBECCA PELLETT · 2011 to 2015
$668k
NCATS NIH HHS UL1 TR000005NCATS NIH HHS UL1 TR001073NIAID NIH HHS K23 AI089271NIAID NIH HHS K23AI089271NIAID NIH HHS UM1 AI068615NIAID NIH HHS UM1AI068615NIAID NIH HHS UM1 AI068633NIAID NIH HHS UM1AI068633NIAID NIH HHS UM1 AI106707NIAID NIH HHS UM1AI106707
6 · The paper itself

Abstract

introductionInnate activity against Escherichia coli in female genital secretions may represent contributions from vaginal bacteria and host soluble immune mediators. We analyzed the relationship between E. coli inhibitory activity, soluble immune mediators, and vaginal bacteria in participants in MTN-004, a placebo-controlled trial of VivaGel(®) , a candidate product for topical HIV pre-exposure prophylaxis.

methodsEscherichia coli inhibitory activity was quantified by colony reduction assay. Endocervical concentrations of interleukin (IL)-1β, IL-6, IL-12p40, macrophage inflammatory protein (MIP)-1α, granulocyte-macrophage colony-stimulating factor (GM-CSF), lactoferrin, and secretory leukocyte protease inhibitor (SLPI) were quantified to generate a cumulative mediator score. Vaginal bacteria were characterized by quantitative cultures.

resultsIn the two placebo arms, higher soluble immune mediator score was associated with greater E. coli inhibitory activity (β = 17.49, 95% CI [12.77, 22.21] and β = 13.28, 95% CI [4.76, 21.80]). However, in the VivaGel arm, higher concentrations of E. coli (β = -3.80, 95% CI [-6.36, -1.25]) and group B Streptococcus (β = -3.91, 95% CI [-6.21, -1.60]) were associated with reduced E. coli inhibitory activity.

conclusionsBoth host mediators and vaginal bacteria impact E. coli inhibition in genital secretions. The relative contributions of host mediators and bacteria varied between women who used VivaGel vs placebos.

Indexed as

Adaptor Proteins, Signal TransducingAdolescentAdultAnti-Bacterial AgentsDendrimersEscherichia coliFemaleGranulocyte-Macrophage Colony-Stimulating FactorHumansImmunologic FactorsInterleukin-12 Subunit p40Interleukin-1betaInterleukin-6LactoferrinMucous MembranePolylysineAdaptor Proteins, Signal TransducingAnti-Bacterial AgentsastodrimerDendrimersGranulocyte-Macrophage Colony-Stimulating FactorIL1B protein, humanIL6 protein, humanImmunologic FactorsInterleukin-12 Subunit p40Interleukin-1betaInterleukin-6LactoferrinMAPKAP1 protein, humanPolylysineSecretory Leukocyte Peptidase InhibitorSLPI protein, humanEscherichia coligenital innate immunityLactobacillus

Identifiers

PMID26118476
PMCPMC4573238
OpenAlexW2131792419

What OpenQuestion holds

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Read underepoch 390

Registered trials

None linked

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.