Prophylactic Vaccines as Therapy: Prevention of Recurrence of Extensive Genital Warts
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Change in the Maximum Size of the Genital Wart Lesion Over the Trial Period (as Measured in mm)
研究概览
简要总结
Large genital warts are frequently diagnosed in general gynaecology and oncology clinics in South Africa. Medical and destructive therapy for small warts is generally very effective, however unique problems posed by large or extensive genital warts are not so easily solved and treatment of affected patients remains very challenging. Recurrences are common especially among immune-compromised women. This study will test whether giving the quadrivalent human papilloma virus (HPV) vaccine to women with extensive genital warts prior to surgical treatment will improve outcomes. Investigators hypothesize that pre-treatment with HPV vaccine can play a role in the control of both malignant and benign HPV disease in women with and without HIV infection through stimulation of the antibody response. In addition, HPV types and other associated diseases will be studied in women receiving HPV vaccine and placebo.
详细描述
Patient selection:
Female patients referred or presenting with genital warts at each site will be eligible and evaluated against the inclusion and exclusion criteria.
Women who are clinically or severely immune-compromised will not be included into the study, but both HIV negative and HIV infected women will be included. Seventy-five women with large or recurrent genital warts will be recruited for this study from 2 sites in South Africa.
Recruitment:
Women with genital warts will be evaluated for inclusion into the study. Those who fit the inclusion criteria and are without any of the exclusion criteria will be fully informed and invited to participate. The first target will be to recruit the first seventy-five consecutive eligible patients who have signed written consent; recruitment for the study will be done for at least 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patient > 16 years
- •Presence of vulvo vaginal genital warts: largest tumour diameter > 3 cm OR Tumour on labia minora and labia majora OR bilateral > 1 cm each side OR Tumour in vagina/cervix as well as on vulva > 1 cm lesion each
- •HIV negative or HIV infected and CD4 ≥ 300 cells/mm3 OR viral load controlled OR anti retro-viral (ARV) compliant > 6 months
排除标准
- •Pregnant of planned pregnancy within 6 months
- •Not able to comprehend study method or not able to attend all study visits
- •Previous HPV vaccination
- •Active known opportunistic infection or malignancy including Pneumocystis pneumonia (PCP),Pulmonary tuberculosis (PTB), oesophageal Candida or Kaposi sarcoma or lymphoma
- •Known allergy to vaccines or content of vaccine
- •Previous radiation for genital warts
研究组 & 干预措施
Quadrivalent HPV vaccine
Three doses of 4 HPV vaccine is given at registered intervals.
干预措施: Quadrivalent HPV vaccine (Biological)
Hepatitis B vaccine
Three doses of Hepatitis B vaccine is given at the same intervals as the quadrivalent HPV vaccine.
干预措施: Hepatitis B vaccine (Biological)
结局指标
主要结局
Change in the Maximum Size of the Genital Wart Lesion Over the Trial Period (as Measured in mm)
时间窗: Baseline, week 8, 24, 60
The number of participants in whom the size of the genital wart lesion(s) measured smaller at Week8, Week24 and Week60 as compared to their baseline measurement (all measured in mm).
次要结局
- Number of Participants Who Acquire Measurable Levels of HPV Type Specific Antibodies During the First 18 Months of the Trail as Measured Using a Competitive Luminex Immuno-assay (cLIA; Reported in Milli-Merck Units [mMU]/ml)(Week 36+)
- Number of Participants Who Change From HPV 6 DNA Positive in Warts to Negative at Week 72(Baseline, week 72)
- Number of Participants Who Change From HPV 11 DNA Positive in Warts to Negative at Week 72(Baseline, week 72)
- Number of Participants Who Change From HPV 16 DNA Positive at Baseline to Negative at Week 60(Baseline, week 60)
- Number of Participants Who Change From HPV 18 DNA Positive at Baseline to Negative at Week 60(Baseline, week 60)
研究者
Professor Greta Dreyer
Professor
University of Pretoria