The stimulation of the vaginal immune system with short-term administration of a vaginal gel containing fraction of Propionibacterium acnes, hyaluronic acid and polycarbophil is efficacious in vaginal infections dependent on disorders in the vaginal ecosystem

Abstract

The vaginal immune system (VIS) is the first defense against antigens recognized as foreign. Substances capable of locally activating the VIS could be a valid strategy to treat vulvo-vaginal infections (VVI), caused by changes in the vaginal ecosystem, such as bacterial vaginosis (BV), vulvo-vaginal candidiasis (CA), and mixed vaginitis (MV). Bacterial lysates, obtained by crushing bacterial cultures, exert immuno-modulatory activities. The parietal fraction from Propionibacterium acnes is a patent of Depofarma (MoglianoVeneto, Italy). The preparation that associates such fraction to hyaluronic acid and polycarbophil is a registered trademark, commercially available in Italy as vaginal gel, Immunovag^®. The study aimed to evaluate whether a 5-day-treatment with Immunovag^® improves the symptoms and signs of VVI, in 60 women with Gardnerella vaginalis (GV), 154 with CA, 95 with MV, diagnosed with vulvar vaginal swab (VVS), and in 283 with BV, diagnosed with the Amsel criteria. At the end of the treatment (visit 2), the symptoms and signs of VVI disappeared in a significant number of subjects (χ²p < .02 vs pre-treatment) in all VVI groups, and their intensity was significantly (p < .0002) reduced in the subjects in which they were still present. Immunovag^® represents a valid treatment of VVI induced by changes in the vaginal ecosystem.

Chinese abstract

在意大利已经商业化, Immunovag®是注册商标。本研究旨在评估使用Immunovag®进行为期5天的治疗是否能改善VVI的症状和体征, 其中60名受试者患有阴道加德纳菌（GV）, 154名患有CA, 95名患有MV, 以上患者均通过外阴阴道拭子（VVS）诊断, 并有283例通过Amsel标准诊断的BV患者。在治疗结束时（访问2）, 在所有VVI组中, VVI的症状和体征在大量的受试者中消失了（χ²p<0.02与治疗前相比）, 并且, 仍有症状的患者中, 症状程度显著减轻（p <0.0002）。Immunovag^®代表了治疗阴道生态系统变化引起的VVI的有效方法。

Keywords:

• Vaginal immune system
• vaginal gel with Propionibacterium acnes
• polycarbophil
• hyaluronic acid
• bacterial vaginosis
• vulvovaginal candidiasis
• mixed vaginitis

Acknowledgements

Special thanks should be addressed to the staff of the secretariat of the department of Obstetrics and Gynecologyof the University of Cagliari (Ms Franca Fadda, and Ms Maria Frongia). The authors thank Kate Jenkins for revising the English language of the manuscript.

All the authors remember with affection, gratitude and esteem their colleague and friend, Dr. Marisa Orrù, who left us before the end of the study.

Disclosure statement

The authors report no conflicts of interest.