@article{103647,
  keywords = {Therapeutic vaccines, T-Lymphocytes, Immunity, Cellular, Immunologic Tests, Adjuvants, Mycobacterium vaccae, Immunotherapy, Drug Therapy, Combination, BCG Vaccine, leprosy},
  author = {Ashinze P and Adenekan T and Noze-Otote O and Akande E and Oladosu D and Egbunu E and Mahmoud A and Fatoye J and Olowookere S and Jegede S and Ahmed A and Ayodele D and Solomon S and Moody F and Owoyemi OP and Umoh J and Ashinze M},
  title = {Therapeutic vaccines and adjunctive immunotherapeutic approaches to multidrug therapy for the management of leprosy: A multiaxial review of evidence and trajectory},
  abstract = {<p><strong>Background:</strong></p>

<p>Leprosy, caused by Mycobacterium leprae and Mycobacterium lepromatosis, is a chronic granulomatous infection affecting the skin and peripheral nerves. Despite the marked reduction in global prevalence attributable to World Health Organization (WHO)-supported multidrug therapy (MDT), persistent transmission, immune-mediated reactional episodes, relapse in multibacillary patients, and long-term disability continue to represent significant public health challenges. Treatment outcomes are largely determined by host immune responses, underscoring the limitations of chemotherapy alone.</p>

<p><br />
Therapeutic vaccines and adjunctive immunotherapeutic approaches may augment protective cell-mediated immunity, accelerate bacterial clearance, attenuate reactional episodes, and reduce relapse risk. Systematically mapping these strategies alongside MDT is essential for identifying evidence gaps and informing future translational research.</p>

<p><strong>Methods:</strong></p>

<p>A scoping review was conducted following the Arksey and O’Malley framework, refined by Joanna Briggs Institute (JBI) recommendations, and reported in accordance with PRISMA-ScR guidelines. Systematic searches were performed in PubMed, Scopus, Web of Science, and the Cochrane Library, restricted to English-language publications from 1980 to 2025. Eligible studies included clinical trials, observational studies, and translational research evaluating therapeutic vaccines and immunotherapeutic agents as adjuncts to MDT. Thirty-five studies met inclusion criteria after independent dual-reviewer screening and full-text assessment.</p>

<p><br />
<strong>Results:</strong></p>

<p>Vaccines including Mycobacterium indicus pranii (MIP), Bacillus Calmette–Guérin (BCG), and the subunit candidate LepVax demonstrated immunological and clinical benefits, particularly in multibacillary disease, including accelerated bacterial index reduction, attenuated reactional episodes, and preliminary evidence for relapse prevention. Cytokine-based strategies, immunomodulators, and host-directed therapies contributed to immune rebalancing and nerve protection. Evidence quality was limited by heterogeneous study designs, small sample sizes, and a paucity of late-phase trials.</p>

<p><strong>Conclusions:</strong></p>

<p>Integrating immunotherapeutic strategies with MDT shows genuine promise for improving leprosy outcomes and supporting global elimination goals. Large-scale, standardized, multicenter trials with validated endpoints are required to generate evidence of sufficient quality for programmatic adoption.</p>
},
  year = {2026},
  journal = {Forum Dermatologicum},
  volume = {12},
  pages = {1 - 12},
  month = {06/2026},
  publisher = {VM Media Group sp. z o.o},
  issn = {2451-151X, 2451-1501},
  url = {https://scholar.google.nl/scholar_url?url=https://journals.viamedica.pl/forum_dermatologicum/article/download/111859/89544&hl=nl&sa=X&d=17504480540371657569&ei=JCEjaoz9IJLwieoPg8Kf8Qk&scisig=ANDmEU6tJJAxnPclY6bWeANbFHou&oi=scholaralrt&hist=732gnZIAAAAJ:25},
  doi = {10.5603/fd.111859},
  language = {ENG},
}