Evidence map›Paper›PMID 35017496›Full record

Trial reportNature communications2022

molBV reveals immune landscape of bacterial vaginosis and predicts human papillomavirus infection natural history.

Mykhaylo Usyk, Nicolas F Schlecht, Sarah Pickering, LaShanda Williams, Christopher C Sollecito, Ana Gradissimo, Carolina Porras, Mahboobeh Safaeian, Ligia Pinto, Rolando Herrero and 6 more

Registry-linked trialOpen access · goldAbstract readClinical Trial
In one paragraph

Trial report in Nature communications, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00128661 (A Double-Blind, Controlled, Randomized, Phase III Study of the Efficacy of an HPV16/18 VLP Vaccine in the Prevention of Advanced Cervical Intraepithelial Neoplasia), which is not on this map. Cited by 33 papers.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed
8.7field-weighted citation impact, top 1% 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.

NCT00128661 phase3completednot on this map

A Double-Blind, Controlled, Randomized, Phase III Study of the Efficacy of an HPV16/18 VLP Vaccine in the Prevention of Advanced Cervical Intraepithelial Neoplasia (CIN2, CIN3, Adenocarcinoma In Situ [AIS] and Invasive Cervical Cancer) Associated With HPV 16 or HPV 18 Cervical Infection in Healthy Young Adult Women in Costa Rica.

TypeinterventionalSponsorGlaxoSmithKlineRan2004 to 2010Enrolled7,466ConditionsCervical Cancer, Precancerous ConditionArmshuman papillomavirus 16/18 L1 virus-like particle/AS04 vaccine, hepatitis A inactivated virus vaccine
3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 59 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Review
  5. Article
  6. Article
  7. Review
  8. Article
  9. Article
  10. Drug and therapeutic intravaginal delivery targeting diseases in the female reproductive tract: A mathematical modeling perspective.Journal of controlled release : official journal of the Controlled Release Society · 2025
    Review
  11. Article
  12. Review
  13. Review
  14. Article
  15. Article
  16. Observational
  17. Article
  18. Review
  19. Article
  20. Article
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

16 authors at 10 institutions in 3 countries.

Mykhaylo UsykDepartment of Pediatrics (Genetic Medicine), Albert Einstein College of Medicine, Bronx, USA.
Nicolas F SchlechtDepartment of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, USA.
Sarah PickeringDepartment of Pediatrics, Mount Sinai Adolescent Health Center, Icahn School of Medicine at Mount Sinai, Manhattan, NY, USA.
LaShanda WilliamsDepartment of Pediatrics (Genetic Medicine), Albert Einstein College of Medicine, Bronx, USA.
Christopher C SollecitoDepartment of Pediatrics (Genetic Medicine), Albert Einstein College of Medicine, Bronx, USA.
Ana GradissimoDepartment of Pediatrics (Genetic Medicine), Albert Einstein College of Medicine, Bronx, USA.
Carolina PorrasAgencia Costarricense de Investigaciones Biomédicas, Fundación INCIENSA, Costa Rica, USA.
Mahboobeh SafaeianRoche Molecular Diagnostics, Pleasanton, CA, USA.
Ligia PintoHPV Serology Laboratory, Frederick National Laboratory for Cancer Research, Fredrick, MD, USA.
Rolando HerreroAgencia Costarricense de Investigaciones Biomédicas, Fundación INCIENSA, Costa Rica, USA.
Howard D StricklerDepartment of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, USA.
Shankar ViswanathanDepartment of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, USA.
Anne Nucci-SackDepartment of Pediatrics, Mount Sinai Adolescent Health Center, Icahn School of Medicine at Mount Sinai, Manhattan, NY, USA.
Angela DiazDepartment of Pediatrics, Mount Sinai Adolescent Health Center, Icahn School of Medicine at Mount Sinai, Manhattan, NY, USA.
Costa Rica HPV Vaccine Trial (CVT) Group
Robert D BurkDepartment of Pediatrics (Genetic Medicine), Albert Einstein College of Medicine, Bronx, USA. robert.burk@einsteinmed.org.ORCID http://orcid.org/0000-0002-8376-8458
Albert Einstein College of Medicine · USInstituto Costarricense de Investigación y Enseñanza en Nutrición y Salud · CRNational Cancer Institute · USDDL Diagnostic Laboratory · NLIcahn School of Medicine at Mount Sinai · USLeidos (United States) · USFrederick National Laboratory for Cancer Research · USGeorgetown University · USRoche (United States) · USRoswell Park Comprehensive Cancer Center · US

Funding

WORD PROCESSORP30CA013330 · NCI · YESHIVA UNIVERSITY · PI STEVEN C. ALMO · 1985 to 2026
$111.2M
Cervical, Anal & Oral HPV Persistence/Adolescent GirlsR01AI072204 · NIAID · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI Robert D Burk, ANGELA DIAZ · 2007 to 2026
$18.6M
PERSISTENT HUMAN PAPILLOMAVIRUS IN WOMEN AT RISK FOR CERVIX CANCERU01CA078527 · NCI · YESHIVA UNIVERSITY · PI BURK, ROBERT D · 2003 to 2018
$8.6M
Investigations Into The Molecular Pathogenesis Of Cervical Glandular NeoplasiasU01CA238592 · NCI · ALBERT EINSTEIN COLLEGE OF MEDICINE · PI BURK, ROBERT D, STRICKLER, HOWARD D · 2020 to 2024
$2.8M
PERSISTENT HPV IN WOMEN AT RISK FOR CERVIX CANCERR01CA078527 · NCI · YESHIVA UNIVERSITY · PI BURK, ROBERT D. · 1998 to 2002
$1.5M
Cervical, Anal & Oral HPV Persistence/Adolescent GirlsR56AI072204 · NIAID · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI BURK, ROBERT D, DIAZ, ANGELA · 2012 to 2012
$835k
NCI NIH HHS N01 CP011005NCI NIH HHS P30 CA013330NCI NIH HHS R01 CA078527NCI NIH HHS U01 CA078527NCI NIH HHS U01 CA238592NIAID NIH HHS R01 AI072204NIAID NIH HHS R56 AI072204
6 · The paper itself

Abstract

Bacterial vaginosis (BV) is a highly prevalent condition that is associated with adverse health outcomes. It has been proposed that BV's role as a pathogenic condition is mediated via bacteria-induced inflammation. However, the complex interplay between vaginal microbes and host immune factors has yet to be clearly elucidated. Here, we develop molBV, a 16 S rRNA gene amplicon-based classification pipeline that generates a molecular score and diagnoses BV with the same accuracy as the current gold standard method (i.e., Nugent score). Using 3 confirmatory cohorts we show that molBV is independent of the 16 S rRNA region and generalizable across populations. We use the score in a cohort without clinical BV states, but with measures of HPV infection history and immune markers, to reveal that BV-associated increases in the IL-1β/IP-10 cytokine ratio directly predicts clearance of incident high-risk HPV infection (HR = 1.86, 95% CI: 1.19-2.9). Furthermore, we identify an alternate inflammatory BV signature characterized by elevated TNF-α/MIP-1β ratio that is prospectively associated with progression of incident infections to CIN2 + (OR = 2.81, 95% CI: 1.62-5.42). Thus, BV is a heterogeneous condition that activates different arms of the immune response, which in turn are independent risk factors for HR-HPV clearance and progression. Clinical Trial registration number: The CVT trial has been registered under: NCT00128661.

Indexed as

AdolescentAdultAlphapapillomavirusBacteriaCytokinesFemaleHumansInterleukin-1betaMetagenomicsMolecular MedicineNeoplasmsPapillomavirus InfectionsRisk FactorsVaginaVaginosis, BacterialYoung AdultCytokinesIL1B protein, humanInterleukin-1beta

Identifiers

PMID35017496
PMCPMC8752746
OpenAlexW4206489983

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.