Evidence map›Paper›PMID 32701396›Full record

ArticleHuman vaccines & immunotherapeutics2021

Optimization and qualification of an assay that demonstrates that a FimH vaccine induces functional antibody responses in women with histories of urinary tract infections.

Courtney M Starks, Michelle M Miller, Peter M Broglie, Joshua Cubbison, Steven M Martin, Gary R Eldridge

Open access · hybridAbstract read
In one paragraph

Article in Human vaccines & immunotherapeutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
1.2field-weighted citation impact, top 21% 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

14 citing papers in PubMed, 25 citations in OpenAlex.

  1. Safety and immunogenicity of an adjuvantedHuman vaccines & immunotherapeutics · 2021
    Trial
  2. UropathogenicAntibiotics (Basel, Switzerland) · 2026
    Review
  3. Biofilm-Forming Capacity andAntibiotics (Basel, Switzerland) · 2026
    Article
  4. Improving the immunogenicity ofFrontiers in immunology · 2026
    Article
  5. Article
  6. Review
  7. Article
  8. Comparative genomics of Shiga toxin-producingFrontiers in veterinary science · 2025
    Article
  9. Article
  10. Conformational ensembles inProceedings of the National Academy of Sciences of the United States of America · 2024
    Article
  11. Article
  12. Article
  13. Article
  14. 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

6 authors at 1 institution in 1 country.

Courtney M StarksSequoia Sciences, Inc., 1912 Innerbelt Business Center Drive , St. Louis, MO, USA.ORCID 0000-0002-2503-8203
Michelle M MillerBioAgilytix Labs, LLC , Durham, NC, USA.
Peter M BroglieBioAgilytix Labs, LLC , Durham, NC, USA.ORCID 0000-0003-2891-6275
Joshua CubbisonBioAgilytix Labs, LLC , Durham, NC, USA.ORCID 0000-0001-6585-7505
Steven M MartinSequoia Sciences, Inc., 1912 Innerbelt Business Center Drive , St. Louis, MO, USA.ORCID 0000-0002-7832-1088
Gary R EldridgeSequoia Sciences, Inc., 1912 Innerbelt Business Center Drive , St. Louis, MO, USA.
Sequoia Sciences (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Recurrent urinary tract infections (rUTI) are a serious disease associated with morbidities and mortality. Resistance to the standard of care antibiotics is now widespread because of the continued use of antibiotics among people who suffer from rUTI. We are therefore developing a vaccine to prevent recurrences among patients with rUTI. The antigen of the vaccine is FimH, a bacterial adhesin protein, and the vaccine is adjuvanted with a TLR-4 agonist. In a Phase 1 clinical study evaluating the vaccine, immunized individuals produced FimH-binding antibodies. Here we describe the optimization, qualification, and use of an assay to assess the functionality of these anti-FimH antibodies. The suitability of the assay for its intended purpose was demonstrated by selectivity, specificity, sensitivity, and intra-assay and inter-assay precision. The acceptance criteria were achieved for all parameters including intra-assay precision with ≤10% relative standard deviations and inter-assay precision with ≤25% relative standard deviations. The results presented herein suggest this functional assay will be important for supporting the vaccine's efficacy in future human studies. Furthermore and of great significance, these results prove that vaccine-induced functional antibodies can be elicited in rUTI patients against an essential virulence factor, FimH.

Indexed as

Urinary Tract InfectionsVaccinesAdhesins, Escherichia coliAntibody FormationFemaleFimbriae ProteinsHumansAdhesins, Escherichia coliFimbriae ProteinsVaccinesfimHfunctional assayTLR-4 agonistUrinary tract infectionvaccine

Identifiers

PMID32701396
PMCPMC7872045
OpenAlexW3044549139

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.