A prospective study to evaluate the bacteriological and antigen-specific immunological responses induced by MIP and/ BCG vaccines as adjunctive treatment (immunotherapy) in multibacillary leprosy patients treated with multidrug therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- 1. Decline in viable bacilli load by quantitative real time PCR (occurrence of persisters) before and after treatment.
研究概览
简要总结
**Background:**Besides untreated multibacillary (MB)leprosy patients, inadequately treated patients with high bacillary load also continue to transmission of leprosy in the community. The potential of MIP/BCG in clearance of viable bacilli and countering the immunological anergy in such patients may have far-reaching implications in controlling or checking the ongoing leprosy transmission in the country. Mere completion of 6 or 12 months of multidrug therapy (MDT) may not be enough in MB leprosy patients with high bacillary load; we need to ensure complete viable bacillary clearance and stronger immunity to prevent relapses and reinfections as well as reduce transmission of leprosy in the community.
Novelty: The outcomes determined will cover the specific bactericidal response, in terms of clearance of viable bacillary load as well as host antigen-specific immunological response (inflammatory vs. immunosuppressive response) as an adjunct therapy, and therefore will provide objective measurement of response to therapy.
Objectives: To study the changes in viable bacillary load and immunmodulation induced by MIP and/ BCG vaccines as immunotherapy in MB leprosy patientstreated with MDT.
**Methods:**Viable bacillary load will be measured by RNA based real time PCR assay. Antigen-specific dendritic cells (DCs) will be generated from peripheral blood derived mononuclear cells in vitro and phenotypic and functional characterization will be done by flow cytometry. The polarization of naïve T cells to Th1/Th2/Th17/Tregs will be determined after co-culturing with M.leprae-specific DCs..
Expected outcome: This study can objectively establish the value of MIPand/ BCG as an immunotherapeutic adjunct in the treatment of MB leprosy. The recommendations based on this study can influence national strategy of the National Leprosy Eradication Program (NLEP) and the WHO goal of a leprosy-free world. The findings could also lead to a strategic decision for the widespread use of MIP or BCG in the National Programme in the treatment of MB leprosy cases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Treatment naïve cases of MB leprosy classified according to WHO classification.
- •Age group: 12- 60 years
- •Patients willing to give consent (for patients aged 12-18years willing to give assent and consent from the legally acceptable representative).
排除标准
- •Paucibacillary (PB) cases of leprosy
- •Defaulter cases
- •Relapse cases
- •Patients on steroids- prednisolone dose >20mg/day for more than 2 weeks
- •Pregnancy or breast feeding
- •With medical co-morbidities like diabetes, cancer, history of or active pulmonary tuberculosis
- •People living with HIV/AIDS.
结局指标
主要结局
1. Decline in viable bacilli load by quantitative real time PCR (occurrence of persisters) before and after treatment.
时间窗: Baseline, at 6 months, at 12 months, at 24 months
2. To study the changes in immune profile of the patients in three treatment arms.
时间窗: Baseline, at 6 months, at 12 months, at 24 months
Outcome measures to be interpreted as per the findings at every 6-month interval.
时间窗: Baseline, at 6 months, at 12 months, at 24 months
次要结局
- Assessment of clinical regression, occurrence and severity of reactions and changes in nerve function, histological upgrading.(Baseline, at 6 months, at 12 months, at 24 months)