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; Thomas M Hooton; Jennifer L Harris

doi:10.3389/fimmu.2024.1359738

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

Front Immunol. 2024 Mar 13:15:1359738. doi: 10.3389/fimmu.2024.1359738. eCollection 2024.

Authors

Affiliations

¹ Family Medicine Associates at Northridge, Northridge, CA, United States.
² Diablo Clinical Research, Walnut Creek, CA, United States.
³ Sequoia Vaccines, Inc., St. Louis, MO, United States.
⁴ Department of Molecular Microbiology and Center for Women's Infectious Disease Research, Washington University School of Medicine, St. Louis, MO, United States.
⁵ Department of Medicine, School of Medicine, University of Miami, Miami, FL, United States.

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.

Keywords: FimH; carbapenem-resistant Enterobacteriaceae; expanded access; urinary tract infection; vaccine.

Publication types

Case Reports
Research Support, Non-U.S. Gov't

MeSH terms

Anti-Bacterial Agents / therapeutic use
Enterobacteriaceae
Follow-Up Studies
Humans
Urinary Tract Infections* / prevention & control
Vaccines* / therapeutic use

Substances

Anti-Bacterial Agents
Vaccines

Grants and funding

The author(s) declare financial support was received for the research, authorship, and/or publication of this article. The authors declare that this study received funding from Sequoia Vaccines. The funder was not involved in the study design, collection, analysis, interpretation of data, the writing of this article or the decision to submit it for publication.