Evidence map›Paper›PMID 33325785›Full record

Trial reportHuman vaccines & immunotherapeutics2021

Safety and immunogenicity of an adjuvanted

Gary R Eldridge, Heidi Hughey, Lois Rosenberger, Steven M Martin, Andrew Marc Shapiro, Elizabeth D'Antonio, Kent G Krejci, Neal Shore, James Peterson, Andrea S Lukes and 1 more

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

Trial report 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 44 papers.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed
3.6field-weighted citation impact, top 6% 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

44 citing papers in PubMed, 59 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Review
  5. Review
  6. Research Progress on perinatalFrontiers in microbiology · 2026
    Review
  7. Article
  8. Improving the immunogenicity ofFrontiers in immunology · 2026
    Article
  9. Article
  10. Article
  11. Review
  12. Article
  13. Article
  14. Article
  15. Article
  16. Review
  17. Article
  18. Article
  19. Article
  20. A cynomolgus monkeyInfection and immunity · 2024
    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

11 authors at 7 institutions in 1 country.

Gary R EldridgeSequoia Sciences, Inc., St. Louis, MO, USA.
Heidi HugheySequoia Sciences, Inc., St. Louis, MO, USA.
Lois RosenbergerLBR Regulatory and Clinical Consulting Services, Inc, Florence, KY, USA.
Steven M MartinSequoia Sciences, Inc., St. Louis, MO, USA.ORCID 0000-0002-7832-1088
Andrew Marc ShapiroLifebridge Health, Owings Mills, MD, USA.
Elizabeth D'AntonioAA Urology, Annapolis, MD, USA.
Kent G KrejciAA Urology, Annapolis, MD, USA.
Neal ShoreAtlantic Urology Clinics, Myrtle Beach, SC, USA.
James PetersonJ. Lewis Research, Salt Lake City, UT, USA.
Andrea S LukesWomen's Wellness Clinic, Carolina Women's Research and Wellness Center (CWRWC), Durham, NC, USA.
Courtney M StarksSequoia Sciences, Inc., St. Louis, MO, USA.ORCID 0000-0002-2503-8203
Sequoia Sciences (United States) · USAmerican Australian Association · USCarolina Urologic Research Center · USCarolina Women's Research and Wellness Center · USLewis University · USLifeBridge Health · USUnited States Nuclear Regulatory Commission · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Antibiotic resistance among gram-negative bacteria continues to rise globally at an alarming rate. New vaccines that prevent bacterial infections and reduce antibiotic use could provide a potential solution to these problems. This study focused on development of an investigational vaccine to prevent recurrent urinary traction infections (UTI) caused by gram-negative bacteria that use type 1 pili to adhere to, invade, and colonize human bladders. The vaccine antigen is FimH, an adhesin protein on the tip of type 1 pili with a lectin binding domain that enables attachment to glycoproteins on mammalian bladders. This was a phase 1, open-label, dose escalation study evaluating the vaccine in 67 healthy women with and without histories of recurrent UTI. The objectives of the study were to evaluate the safety, tolerability, and immunogenicity of different dosages of the antigen and adjuvant of the vaccine. All dosages were well-tolerated and a low incidence of systemic reactions occurred. No serious adverse events related to the vaccine were reported. The vaccine induced both binding and functional antibodies. The women with histories of recurrent UTI demonstrated greater than 150-fold increases in antibodies against the N-terminal region of FimH. Based on the results of this phase 1 study, this vaccine is proceeding to a double-blind, randomized, placebo-controlled phase 2 study. If this vaccine is successful in future studies, it could potentially prevent millions of recurrent UTI globally and reduce the development of antibiotic resistance.

Indexed as

Escherichia coli InfectionsEscherichia coli VaccinesUrinary Tract InfectionsAdhesins, Escherichia coliAdjuvants, ImmunologicAnimalsAnti-Bacterial AgentsFemaleHumansImmunogenicity, VaccineAdhesins, Escherichia coliAdjuvants, ImmunologicAnti-Bacterial AgentsEscherichia coli VaccinesFimHphase 1TLR4 agonistUrinary tract infectionvaccine

Identifiers

PMID33325785
PMCPMC8078672
OpenAlexW3111937933

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.