Original Article

An intention-to-treat-analysis of the efficacy of immunotherapy using Mycobacterium w vaccine and Purified Protein Derivative of Tuberculin for warts with assessment of improvement in quality of life

Author Affiliation(s)


Introduction: Lately, immunotherapy has evolved as a safe and reliable management option for treatment of warts. Various immunogens among others in use include vaccines and antigens like purified Protein Derivative of Tuberculin (PPD) and mycobacterium w (Mw) or mycobacterium indicum prani vaccines.

Objectives: The study was aimed to assess the effectiveness and safety profile of intralesional Mw vaccine against intralesional PPD for the management of multiple warts with assessment of the improvement in quality of life (QoL) using the Dermatology Life Quality Index questionnaire.

Methods: Patients aged above 12 years with ≥2 warts were recruited for the study. These individuals were randomized into groups A and B, namely Mw vaccine (group A) and PPD Tuberculin (group B). At each visit, 0.1-0.2 ml of active antigen was infiltrated intralesionally into the largest/mother wart. The injections were repeated after every 4 weeks, for the next 12 weeks. QoL improvement was measured.

Results: This intention to treat analysis was completed by 102 patients, of which 55 were in group A and 47 in group B. The rate of complete clearance was comparable in group A (76.3%) with the one in group B (65.9%, P = 0.064). Prior to treatment initiation, the most severely impacted domain of life by warts was ‘symptoms and feelings’. There was a statistically significant improvement in QoL at the end of the treatment ( P <0.01).

Conclusions: Mw vaccine holds leverage over PPD with a marginally higher rate of clearance and less adverse events for managing warts.

Keywords : HPV, PPD tuberculin, immuvac vaccine, Mw vaccine, intralesional immunogens, warts


1. Forman D, de Martel C, Lacey CJ, et al. Global burden of human papillomavirus and related diseases. Vaccine. 2012;30 Suppl 5:F12-F23. DOI: 10.1016/j.vaccine.2012.07.055. PMID: 23199955.. 2. Sterling JC, Handfield-Jones S, Hudson PM; British Association of Dermatologists. Guidelines for the management of cutaneous warts. Br J Dermatol. 2001;144(1):4-11. doi: 10.1046/j.1365-2133.2001.04066.x. PMID: 11167676. 3. Salman S, Ahmed MS, Ibrahim AM, et al. Intralesional immunotherapy for the treatment of warts: A network meta-analysis. J Am Acad Dermatol. 2019;80 (4):922-930.e4. doi: 10.1016/j.jaad.2018.07.003. PMID: 30003983. 4. Dhakar AK, Dogra S, Vinay K, Sarangal R, Kanwar AJ, Singh MP. Intralesional Mycobacterium w Vaccine Versus Cryotherapy in Treatment of Refractory Extragenital Warts: A Randomized, Open-Label, Comparative Study. J Cutan Med Surg. 2016;20(2):123-129. DOI: 10.1177/1203475415616962. PMID: 26553733. 5. Salah E. Impact of multiple extragenital warts on quality of life in immune-competent Egyptian adults: a comparative cross-sectional study. Clin Cosmet Investig Dermatol. 2018;11:289-295. DOI: 10.2147/CCID.S165908. PMID: 29928139. PMCID: PMC6001836. 6. Talwar GP, Gupta JC, Mustafa AS, et al. Development of a potent invigorator of immune responses endowed with both preventive and therapeutic properties. Biologics. 2017;11:55-63. DOI: 10.2147/BTT.S128308. PMID: 28496303. PMCID: PMC5422320. 7. Amirnia M, Khodaeiani E, Fouladi DF, Masoudnia S. Intralesional immunotherapy with tuberculin purified protein derivative (PPD) in recalcitrant wart: A randomized, placebo-controlled, double-blind clinical trial including an extra group of candidates for cryotherapy. J Dermatolog Treat. 2016;27(2):173-178. DOI: 10.3109/09546634.2015.1078871. PMID: 26295565. 8. Gupta S, Malhotra AK, Verma KK, Sharma VK. Intralesional immunotherapy with killed Mycobacterium w vaccine for the treatment of ano-genital warts: an open label pilot study. J Eur Acad Dermatol Venereol. 2008;22(9):1089-1093. DOI: 10.1111/j.1468-3083.2008.02719.x. PMID: 18484970. 9. Meena JK, Malhotra AK, Mathur DK, Mathur DC. Intralesional immunotherapy with Mycobacterium w vaccine in patients with multiple cutaneous warts: uncontrolled open study. JAMA Dermatol. 2013;149(2):237-239. DOI: 10.1001/jamadermatol.2013.866. PMID: 23426493. 10. Chandra S, Sil A, Datta A, Pal S, Das NK. A double-blind, randomized controlled trial to compare the effectiveness and safety of purified protein derivative of tuberculin antigen with Mycobacterium w vaccine in the treatment of multiple viral warts. Indian J Dermatol Venereol Leprol. 2019;85:355-66. DOI: 10.4103/ijdvl.IJDVL_549_18. PMID: 31172979. 11. Singh S, Chouhan K, Gupta S. Intralesional immunotherapy with killed Mycobacterium indicus pranii vaccine for the treatment of extensive cutaneous warts. Indian J Dermatol Venereol Leprol. 2014;80(6):509-514. DOI: 10.4103/0378-6323.144145. PMID: 25382507. 12. Garg S, Baveja S. Intralesional immunotherapy for difficult to treat warts with Mycobacterium w vaccine. J Cutan Aesthet Surg. 2014;7(4):203-208. DOI: 10.4103/0974-2077.150740. PMID: 25722598. PMCID: PMC4338463. 13. Kus S, Ergun T, Gun D, Akin O. Intralesional tuberculin for treatment of refractory warts. J Eur Acad Dermatol Venereol. 2005;19:515-516. DOI: 10.1111/j.1468-3083.2004.01176.x. PMID: 15987315. 14. Nimbalkar A, Pande S, Sharma R, Borkar M. Tuberculin purified protein derivative immunotherapy in the treatment of viral warts. Indian J Drugs Dermatol. 2016;2:19-23. DOI: 10.4103/2455-3972.184103 15. Saoji V, Lade NR, Gadegone R, Bhat A. Immunotherapy using purified protein derivative in the treatment of warts: An open uncontrolled trial. Indian J Dermatol Venereol Leprol. 2016;82:42-46. DOI: 10.4103/0378-6323.171650. PMID: 26728809. 16. Wananukul S, Chatproedprai S, Kittiratsacha P. Intralesional immunotherapy using tuberculin PPD in the treatment of palmoplantar and periungual warts. Asian Biomed. 2009;3:739-743. DOI: 10.5372/ABM.V3I6.279.

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