Family Medicine Associates at Northridge, Northridge, CA, United States.
Diablo Clinical Research, Walnut Creek, CA, United States.
Front Immunol. 2024 Mar 13;15:1359738. doi: 10.3389/fimmu.2024.1359738. eCollection 2024.
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.
根据疾病控制与预防中心（CDC）和世界卫生组织（WHO）的数据，碳青霉烯类耐药肠杆菌科（CRE）引起的尿路感染（UTI）被认为是对人类健康最紧迫的威胁之一。一项 FimCH 疫苗扩大使用研究正在对有抗生素耐药性 UTI 病史且被认为有发生 CRE UTI 风险的患者进行。本病例系列描述了接受 FimCH 四价疫苗系列接种的 4 名参与者的临床、安全性和免疫原性发现。在接种第四剂疫苗后 12 个月，对参与者进行安全性、总体健康状况和 UTI 发生情况的随访。该研究后来被修订，允许在接种疫苗后最多五年进行额外随访，以评估长期健康状况、UTI 发生情况，并获取血液样本进行抗 FimH 抗体检测。在我们的 4 名研究参与者人群中，在抗 FimH 抗体反应峰值后 12 个月内，由革兰氏阴性菌引起的有症状 UTI 发生次数比研究入组前 12 个月减少了约 75%。这些结果与同一 FimCH 疫苗的一项 1 期 30 例患者队列研究一致。在所有 4 名参与者的长期随访期间，UTI 发生次数增加，但未达到接种前观察到的水平。在长期随访期间，未发现与 FimCH 疫苗相关的新的安全性问题。本病例系列具有临床意义和公共卫生相关性，因为它检查和报告了在高风险复发性尿路感染患者中接种 FimCH 疫苗后 UTI 的频率和复发情况。此外，参与者在接种疫苗后描述了改善的健康状况，这种状况在长期随访期间得以维持。
