| CTRI Number |
CTRI/2020/11/028803 [Registered on: 02/11/2020] Trial Registered Prospectively |
| Last Modified On: |
20/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Evaluation of bacteriological and immunological responses induced by MIP and/ BCG vaccines in multibacillary leprosy patients |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Seema Chhabra |
| Designation |
Assistant Professor |
| Affiliation |
Post Graduate Institute of Medical Sciences, Chandigarh |
| Address |
Department of Immunopathology, Room no. 22, 4th Floor, Research Block A, PGIMER, Sector-12.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9888012757 |
| Fax |
|
| Email |
drseemachhabra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Seema Chhabra |
| Designation |
Assistant Professor |
| Affiliation |
Post Graduate Institute of Medical Sciences, Chandigarh |
| Address |
Department of Immunopathology, Room no. 22, 4th Floor, Research Block A, PGIMER, Sector-12.
CHANDIGARH
160012
India |
| Phone |
9888012757 |
| Fax |
|
| Email |
drseemachhabra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Seema Chhabra |
| Designation |
Assistant Professor |
| Affiliation |
Post Graduate Institute of Medical Sciences, Chandigarh |
| Address |
Department of Immunopathology, Room no. 22, 4th Floor, Research Block A, PGIMER, Sector-12.
CHANDIGARH
160012
India |
| Phone |
9888012757 |
| Fax |
|
| Email |
drseemachhabra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian council of Medical Research (ICMR), New Delhi |
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
V Ramalingaswamy Bhawan, Ansari Nagar, POSTBOX4911.NEW DELHI- 110029 |
| Type of Sponsor |
Government funding agency |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Seema Chhabra |
PGIMER, Chandigarh |
Department of Immunopatholgy, room no.22, 4th Floor, Research Block-A, PGIMER, Sector-12, Chandigarh
Chandigarh
CHANDIGARH |
09888012757
drseemachhabra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstituteEthicsCommittee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
75 age-sex matched healthy controls |
| Patients |
(1) ICD-10 Condition: A304||Borderline lepromatous leprosy, (2) ICD-10 Condition: A303||Borderline leprosy, (3) ICD-10 Condition: A302||Borderline tuberculoid leprosy, (4) ICD-10 Condition: A305||Lepromatous leprosy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
BCG vaccine |
There will be 3 study groups in the plan. The comparator group is group C which will receive the standard WHO MDT (MBR) with normal saline (placebo) at 0 and 3 months. the details of the three groups are..
Group A: will receive 12 months of conventional WHO multi drug treatment (MDT) multibacillary regimen (MBR) which comprises of Cap Rifampicin 600mg or 450mg and cap clofazimine 300mg once a month and tab dapsone 100mg and cap clofazimine 50mg once a day by oral route for 12 months and 2 doses of Immunotherapy with 0.1 ml of Inj MIP injected intra-dermal in the deltoid area at the start of therapy and at 3 months. MIP is dispensed as a 0.6ml vial as a colourless opaque suspension, each 0.1 ml containing sodium chloride 0.9 w/v, Thiomersal IP 0.01% w/v with non-visible cells of MIP 0.5 x 109 bacilli.
Group B: will receive 12 months of conventional WHO multi drug treatment (MDT) multibacillary regimen (MBR) and 2 doses of BCG 0.1 ml, injected intradermal at the start of therapy and at 3 months.
Group C: will receive 12 months of conventional WHO multi drug treatment (MDT) multibacillary regimen (MBR) and 2 doses of 0.1 ml of normal saline at initiation and 3 months after the first dose.
Allocation ratio: The allocation ratio will be 2:2:1 for Group A: Group B: Group C
|
| Intervention |
MIP vaccine or BCG vaccine |
2 doses of MIP vaccine 0.1 ml intradermally at 0 and 3 months, or 2 doses of BCG vaccine 0.1 ml intradermally at 0 and 3 months along with the WHO multidrug therapy (multibacillary regime) |
|
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Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Treatment naïve cases of MB leprosy classified according to WHO classification.
2. Age group: 12- 60 years
3. Patients willing to give consent (for patients aged 12-18years willing to give assent and consent from the legally acceptable representative)
|
|
| ExclusionCriteria |
| Details |
Paucibacillary (PB) cases of leprosy
2. Defaulter cases
3. Relapse cases
4. Patients on steroids- prednisolone dose >20mg/day for more than 2 weeks
5. Pregnancy or breast feeding
6. With medical co-morbidities like diabetes, cancer, history of or active pulmonary tuberculosis
7. People living with HIV/AIDS
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Decline in viable bacilli load by quantitative real time PCR (occurrence of persisters) before and after treatment.
2. To study the changes in immune profile of the patients in three treatment arms.
Outcome measures to be interpreted as per the findings at every 6-month interval. |
Baseline, at 6 months, at 12 months, at 24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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 |
|
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Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
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. |