{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T10:15:19Z","timestamp":1788257719272,"version":"build-2803163510"},"reference-count":27,"publisher":"Scientific Scholar","content-domain":{"domain":["ijmr.org.in"],"crossmark-restriction":true},"short-container-title":["Indian J Med Res"],"abstract":"<jats:sec>\n                    <jats:title>Background and objectives<\/jats:title>\n                    <jats:p>\n                      Leprosy is a neglected tropical disease caused by\n                      <jats:italic>Mycobacterium leprae<\/jats:italic>\n                      often resulting in nerve damage, numbness, disfiguring lesions, and disability. India accounts for \u223c52% of the world\u2019s new leprosy patients. Immunotherapy has been reported to achieve faster bacterial clearance in multi-bacillary (MB) leprosy patients. We conducted this systematic review to synthesise the global evidence available for the efficacy and safety of the MIP vaccine (\n                      <jats:italic>Mycobacterium indicus pranii<\/jats:italic>\n                      ), previously known as Mw, as an immunotherapeutic agent along with standard chemotherapy, on the treatment outcomes in patients with multi-bacillary (MB) and pauci-bacillary (PB) leprosy.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Three bibliographic databases namely, PubMed, Embase, and Cochrane Library were used for search of articles apart from four clinical trial registries, Google Scholar, and the Google search engine. Articles published between 1980 to 2023 reporting the efficacy of the MIP vaccine for immunotherapy along with standard chemotherapy in leprosy patients were included. Methodological bias was assessed using the RoB2 and ROBIN-I tool. Meta-analysis was carried out from four RCTs and three non-RCTs for the outcomes clinical score and bacterial index following 12 and 24 mo of treatment using the Review Manager 5.4.1 (RevMan).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The pooled analysis of four RCTs with 12 and 24 mo of follow up showed a significant reduction in clinical scores with mean difference of \u20131.35 [95% confidence interval (CI): \u20132.12 to \u20130.57] and \u20132.62 (95% CI: \u20134.28 to \u20130.96) respectively, while the analysis of three non-RCTs showed a mean difference of \u20132.97 (95% CI: \u20134.00 to \u20131.94) and \u20133.10 (95% CI: \u20133.84 to \u20132.37) at 12 and 24 mo respectively. Subgroup analysis showed a significant reduction in clinical scores and bacterial index among borderline lepromatous (BL) and lepromatous leprosy (LL) types of leprosy. The vaccine was reported to be safe and well-tolerated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Interpretation and conclusions<\/jats:title>\n                    <jats:p>This systematic review and meta-analysis confirms the clinical efficacy of the MIP as an immunotherapeutic vaccine in leprosy patients for rapid bacterial clearance and overall clinical improvement when used as an adjunct to chemotherapy.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.25259\/ijmr_538_2026","type":"journal-article","created":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T10:00:48Z","timestamp":1787652048000},"page":"365-376","update-policy":"https:\/\/doi.org\/10.25259\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Immunotherapeutic effect of MIP vaccine along with multidrug therapy (MDT) in leprosy: A systematic review and meta-analysis"],"prefix":"10.25259","volume":"164","author":[{"given":"Madhumathi","family":"Jayaprakasam","sequence":"first","affiliation":[{"name":"Division of Communicable Diseases, Indian Council of Medical Research, New Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jigisha","family":"Chaudhary","sequence":"additional","affiliation":[{"name":"Division of Communicable Diseases, Indian Council of Medical Research, New Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deenadayalan","family":"Boopalan","sequence":"additional","affiliation":[{"name":"Department of Yoga and Naturopathy, Central Council for Research in Yoga and Naturopathy (CCRYN), Ministry of Ayush, New Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rizwan Suliankatchi","family":"Abdulkader","sequence":"additional","affiliation":[{"name":"Department of ICMR School of Public Health, ICMR-National Institute of Epidemiology, Chennai, Tamil Nadu, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nivedita","family":"Gupta","sequence":"additional","affiliation":[{"name":"Division of Communicable Diseases, Indian Council of Medical Research, New Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"10894","published-online":{"date-parts":[[2026,8,24]]},"reference":[{"key":"10.25259\/IJMR_538_2026\/ref-1","doi-asserted-by":"publisher","first-page":"8652062","DOI":"10.1155\/2022\/8652062","article-title":"Leprosy: A review of epidemiology, Clinical diagnosis, and management","volume":"2022","author":"Chen","year":"2022","journal-title":"J Trop Med."},{"key":"10.25259\/IJMR_538_2026\/ref-5","first-page":"311","article-title":"Current leprosy burden: India should lead the way","volume":"95","author":"Mukhida","year":"2023","journal-title":"Indian J Lepr."},{"key":"10.25259\/IJMR_538_2026\/ref-6","doi-asserted-by":"publisher","first-page":"200","DOI":"10.1016\/j.clindermatol.2019.01.002","article-title":"Leprosy: A great imitator","volume":"37","author":"Kundakci","year":"2019","journal-title":"Clin Dermatol."},{"key":"10.25259\/IJMR_538_2026\/ref-7","doi-asserted-by":"publisher","first-page":"179","DOI":"10.5935\/0305-7518.20000020","article-title":"Mycobacterium w vaccine, a useful adjuvant to multidrug therapy in multibacillary leprosy: A report on hospital based immunotherapeutic clinical trials with a follow-up of 1-7 years after treatment","volume":"71","author":"Sharma","year":"2000","journal-title":"Lepr Rev."},{"key":"10.25259\/IJMR_538_2026\/ref-8","doi-asserted-by":"publisher","first-page":"3649","DOI":"10.1016\/j.vaccine.2004.03.037","article-title":"10-12 years follow-up of highly bacillated BL\/LL leprosy patients on combined chemotherapy and immunotherapy","volume":"22","author":"Katoch","year":"2004","journal-title":"Vaccine."},{"key":"10.25259\/IJMR_538_2026\/ref-9","first-page":"369","article-title":"Comparative leprosy vaccine trial in south India","volume":"70","author":"Gupte","year":"1998","journal-title":"Indian J Lepr."},{"key":"10.25259\/IJMR_538_2026\/ref-10","doi-asserted-by":"crossref","first-page":"127","DOI":"10.47276\/lr.76.2.127","article-title":"Immunoprophylactic effects of the anti-leprosy Mw vaccine in household contacts of leprosy patients: Clinical field trials with a follow up of 8\u201310 years","volume":"76","author":"Sharma","year":"2005","journal-title":"LEPROSY."},{"key":"10.25259\/IJMR_538_2026\/ref-11","doi-asserted-by":"publisher","first-page":"293","DOI":"10.25259\/IJMR_1289_2024","article-title":"Efficacy of leprosy vaccines across the globe: A systematic review meta-analysis of randomised controlled trials","volume":"160","author":"Dasgupta","year":"2024","journal-title":"Indian J Med 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patients","volume":"13","author":"Zaheer","year":"1995","journal-title":"Vaccine."},{"key":"10.25259\/IJMR_538_2026\/ref-21","first-page":"202","article-title":"Treatment of bacilliferous BL\/LL cases with combined chemotherapy and immunotherapy","volume":"63","author":"Katoch","year":"1995","journal-title":"Int J Lepr Other Mycobact Dis."},{"key":"10.25259\/IJMR_538_2026\/ref-22","first-page":"187","article-title":"Impact of combined Mycobacterium w vaccine and 1 year of MDT on multibacillary leprosy patients","volume":"69","author":"De Sarkar","year":"2001","journal-title":"Int J Lepr Other Mycobact Dis."},{"key":"10.25259\/IJMR_538_2026\/ref-23","first-page":"174","article-title":"Combined 12-month WHO\/MDT MB regimen and Mycobacterium w vaccine in multibacillary leprosy: A follow-up of 136 patients","volume":"70","author":"Kaur","year":"2002","journal-title":"Int J Lepr Other Mycobact Dis."},{"key":"10.25259\/IJMR_538_2026\/ref-24","first-page":"105","article-title":"Comparative evaluation of immunotherapeutic efficacy of BCG and Mw vaccines in patients of borderline lepromatous and lepromatous leprosy","volume":"73","author":"Narang","year":"2005","journal-title":"Int J Lepr Other Mycobact Dis."},{"key":"10.25259\/IJMR_538_2026\/ref-25","first-page":"287","article-title":"Clinical and histopathological evaluation of the effect of addition of immunotherapy with Mw vaccine to standard chemotherapy in borderline leprosy","volume":"84","author":"Kamal","year":"2012","journal-title":"Indian J Lepr."},{"key":"10.25259\/IJMR_538_2026\/ref-26","doi-asserted-by":"publisher","first-page":"1439","DOI":"10.1021\/ja00419a053","article-title":"Addition of immunotherapy to chemotherapy in pediatric borderline leprosy: A clinical evaluation","author":"Kamal","year":"2016","journal-title":"Int J Contemp Pediatr."},{"key":"10.25259\/IJMR_538_2026\/ref-27","doi-asserted-by":"crossref","first-page":"1388","DOI":"10.1111\/bjd.14971","article-title":"Addition of Mycobacterium 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