Uehling David T, Hopkins Walter J, Elkahwaji Johny E, Schmidt Dianne M, Leverson Glen E
Department of Surgery, Division of Urology, University of Wisconsin Medical School, 600 Highland Avenue, G5/539 CSC, Madison, WI 53792-3236, USA.
J Urol. 2003 Sep;170(3):867-9. doi: 10.1097/01.ju.0000075094.54767.6e.
Recurrent urinary tract infections (UTIs) in susceptible women remain a common urological condition. With an increasing number of UTIs being caused by antibiotic resistant bacteria there is a need for alternatives to antibiotics. We determined whether multiple doses of a vaginal mucosal vaccine are effective for increasing long-term resistance to recurrent UTIs.
A total of 54 women were entered into a double-blind, placebo controlled, phase 2 clinical trial using a vaginal vaccine containing 10 heat killed uropathogenic bacteria. Patients were withdrawn from prophylactic antibiotics and randomly assigned to 1 of 3 treatment groups, namely placebo only, primary immunization or primary plus booster immunizations. Subjects received treatments at 0, 1, 2, 6, 10 and 14 weeks. Placebo treated patients received suppositories without bacteria. The primary immunization group received vaccine suppositories, followed by 3 doses of placebo. Patients receiving booster immunizations were given 6 vaccine suppositories. All women were followed for 6 months to determine the time until first recurrence, number of infections and adverse reactions.
Women receiving 6 vaccine doses remained free of infections for a significantly longer period than those receiving placebo or primary immunizations. Of patients receiving 6 immunizations 55% did not experience an infection, whereas 89% of placebo treated women had UTIs. No women had significant adverse effects.
This study demonstrates that vaginal mucosal vaccine given for a 14-week period increased the time to re-infection in UTI susceptible women. The infrequent, minimal adverse reactions confirm previous observations on the safety of this vaginal mucosal immunization regimen.
易感女性复发性尿路感染（UTIs）仍是一种常见的泌尿系统疾病。随着抗生素耐药菌导致的UTIs数量不断增加，需要抗生素的替代物。我们确定多剂量阴道黏膜疫苗是否能有效增强对复发性UTIs的长期抵抗力。
共有54名女性参与一项双盲、安慰剂对照的2期临床试验，使用一种含有10种热灭活尿路致病性细菌的阴道疫苗。患者停用预防性抗生素，并随机分配到3个治疗组之一，即仅用安慰剂、初次免疫或初次加加强免疫。受试者在第0、1、2、6、10和14周接受治疗。接受安慰剂治疗的患者接受不含细菌的栓剂。初次免疫组接受疫苗栓剂，随后3剂安慰剂。接受加强免疫的患者给予6剂疫苗栓剂。所有女性随访6个月，以确定首次复发的时间、感染次数和不良反应。
接受6剂疫苗的女性无感染的时间明显长于接受安慰剂或初次免疫的女性。接受6次免疫的患者中，55%未发生感染，而接受安慰剂治疗的女性中有89%发生UTIs。没有女性出现明显不良反应。
本研究表明，为期14周给予阴道黏膜疫苗可延长UTIs易感女性再次感染的时间。罕见、轻微的不良反应证实了此前关于这种阴道黏膜免疫方案安全性的观察结果。
