NCT02173184Unknown3 期
Phase III, Randomized, Double Blind, Parallel Groups, Placebo Controlled Clinical Study to Evaluate the Efficacy and Safety of the Lactobacillus Vaccine Gynevac, in the Treatment of Bacterial Vaginosis
Amvac Kft.8 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2014年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 240
- 试验地点
- 8
- 主要终点
- Therapeutic response
研究概览
简要总结
To investigate the efficacy (therapeutic response) of Gynevac vaccination following a 5-shot treatment period in patients with bacterial vaginosis, based on the Nugent Score and the Amsel criteria
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult premenopausal females, 18 years and older.
- •Mentally competent patients that can comply with the study protocol and are able to complete and keep or study related material (patient diaries, etc.).
- •Signed and dated written informed consent.
- •Clinical diagnosis of BV according to Amsel criteria
- •Gram stains Nugent Score ≥7 or Nugent Score 4-6 with the presence of clue cells
- •Patient does not need an anti-infective treatment which would be required for specific treatment of vaginosis or to prevent the development of acute vaginitis and which may affect treatment outcome of BV.
- •Negative pregnancy test at screening.
排除标准
- •Patients with other infectious causes of vulvovaginitis (e.g. Vaginal candidiasis, Trichomonas vaginalis).
- •Patients with another vaginal or vulvar condition, which would confound the interpretation of clinical and or therapeutic response.
- •Patients who received antifungal or antimicrobial therapy (systemic or intravaginal), as part of standard clinical practice, or clinical trial, within 14 days of randomization.
- •Patients who are diagnosed with a chronic inflammatory disease (Rheumatoid Arthritis, psoriasis, Crohn's disease, Coeliac disease, spondyloarthritis rheumatica etc.)
- •Women who are scheduled to be under treatment during the study period for cervical intraepithelial neoplasia (CIN) or cervical carcinoma.
- •Pregnancy or lactation.
- •Patients with known hypersensitivity to formaldehyde.
- •Patients undergoing antibiotic treatment.
- •Patients with acute polyarthritis, known serious cardiac, liver, kidney diseases or unstable diabetes mellitus.
- •Known abnormalities of the blood circulation or of the haemopoietic system.
- •Use of any investigational drug within 30 days from randomization.
- •Patients who do not abstain from use of intravaginal products for at least 7 days prior to study randomization (e.g. douches, female deodorant sprays, spermicides, condoms, tampons, and diaphragms). Patients should also refrain from using intravaginal products 3 days prior to each study visit.
- •Patients who do not abstain from vaginal intercourse during at least 3 days prior to each study visit.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo vehicle (0.9% NaCl solution)
干预措施: Placebo (Biological)
Gynevac
Experimental
Gynevac suspension for injection, a vaccine containing Lactobacillus strains 15, 34, 79, 84, 127 inactivated by formaldehyde in 0.9% NaCl solution
干预措施: Gynevac (Biological)
结局指标
主要结局
Therapeutic response
时间窗: 3 weeks from the time of last vaccine administration (+3 days maximum)
The percentage of patients with remission according to Amsel's criteria at week 7: resolution of the clinical findings assessed at baseline, and remission according to Gram stain Nugent score: score \< 4 or 4 to 6 with no presence of clue cells at week 7.
次要结局
- Clearance of BV infection according to Nugent Score(3 weeks from the time of last vaccine administration (+3 days maximum))
- Clearance of BV infection according to Amsel criteria(3 weeks from the time of last vaccine administration (+3 days maximum))
- Overall therapeutic failure(3 weeks from the time of last vaccine administration (+3 days maximum))
- Change in pre- and post-vaccination IgA, IL17, and IFNγ(3 weeks from the time of last vaccine administration (+3 days maximum))
- Change in Nugent Score(3 weeks from the time of last vaccine administration (+3 days maximum))
研究者
研究点 (8)
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