Evidence map›Paper›PMID 38545110›Full record

ArticleFrontiers in immunology2024

Case report: Long-term follow-up of patients who received a FimCH vaccine for prevention of recurrent urinary tract infections caused by antibiotic resistant Enterobacteriaceae: a case report series.

Elise Perer, Helen Stacey, Terri Eichorn, Heidi Hughey, Julie Lawrence, Eric Cunningham, Mark O'Neil Johnson, Kevin Bacon, Andrew Kau, Scott J Hultgren and 2 more

Open access · goldAbstract readCase Reports
In one paragraph

Article in Frontiers in immunology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
3.9field-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

11 citing papers in PubMed, 10 citations in OpenAlex.

  1. UropathogenicAntibiotics (Basel, Switzerland) · 2026
    Review
  2. Review
  3. Article
  4. Review
  5. Fimbriae potentiateCurrent research in microbial sciences · 2026
    Review
  6. Improving the immunogenicity ofFrontiers in immunology · 2026
    Article
  7. Article
  8. Review
  9. Article
  10. Article
  11. 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

12 authors at 4 institutions in 1 country.

Elise PererFamily Medicine Associates at Northridge, Northridge, CA, United States.
Helen StaceyDiablo Clinical Research, Walnut Creek, CA, United States.
Terri EichornSequoia Vaccines, Inc., St. Louis, MO, United States.
Heidi HugheySequoia Vaccines, Inc., St. Louis, MO, United States.
Julie LawrenceSequoia Vaccines, Inc., St. Louis, MO, United States.
Eric CunninghamSequoia Vaccines, Inc., St. Louis, MO, United States.
Mark O'Neil JohnsonSequoia Vaccines, Inc., St. Louis, MO, United States.
Kevin BaconSequoia Vaccines, Inc., St. Louis, MO, United States.
Andrew KauDepartment of Molecular Microbiology and Center for Women's Infectious Disease Research, Washington University School of Medicine, St. Louis, MO, United States.
Scott J HultgrenDepartment of Molecular Microbiology and Center for Women's Infectious Disease Research, Washington University School of Medicine, St. Louis, MO, United States.
Thomas M HootonDepartment of Medicine, School of Medicine, University of Miami, Miami, FL, United States.
Jennifer L HarrisSequoia Vaccines, Inc., St. Louis, MO, United States.
Sequoia Sciences (United States) · USWashington University in St. Louis · USDiablo Clinical Research · USUniversity of Miami · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Urinary tract infections (UTI) caused by carbapenem-resistant Enterobacteriaceae (CRE) are considered one of the most urgent health threats to humans according to the Centers for Disease Control (CDC), and the World Health Organization (WHO). A FimCH Vaccine expanded access study is being conducted in patients with a history of antibiotic resistant UTIs who are considered to be at risk for development of CRE UTI. This case series describes the clinical, safety and immunogenicity findings for four participants who received a FimCH four-vaccine series. Participants were followed for 12 months after administration of the fourth vaccine for safety, general health status and UTI occurrence. The study was later amended to allow additional follow-up of up to five years post vaccine administration to assess long-term health status, UTI occurrences and to obtain blood samples for anti-FimH antibody testing. In our population of 4 study participants, the number of symptomatic UTI occurrences caused by gram-negative bacteria in the 12-month period following peak anti-FimH antibody response were approximately 75% lower than the 12-month period preceding study enrollment. These results are consistent with the 30-patient cohort of a Phase 1 study with the same FimCH Vaccine. UTI occurrences increased during the long-term follow-up period for all 4 participants but did not reach the rate observed pre-vaccination. No new safety concerns related to the FimCH Vaccine were identified during long-term follow-up. This case series has clinical importance and public health relevance since it examines and reports on UTI frequency and recurrence following vaccination with the FimCH Vaccine in a high-risk population of patients with recurrent UTI. Additionally, participants described improved well-being following vaccination which was maintained in the long-term follow-up period.

Indexed as

Urinary Tract InfectionsVaccinesAnti-Bacterial AgentsEnterobacteriaceaeFollow-Up StudiesHumansAnti-Bacterial AgentsVaccinescarbapenem-resistant Enterobacteriaceaeexpanded accessFimHurinary tract infectionvaccine

Identifiers

PMID38545110
PMCPMC10966921
OpenAlexW4392750052

What OpenQuestion holds

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LicenceCC BY
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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.