title: Intralesional injection of Mycobacterium w vaccine vs imiquimod, 5%, cream in patients with anogenital warts: a randomized clinical trial.
abstract: OBJECTIVE
  Intralesional antigen therapy has been used in the treatment of anogenital warts (AGWs), but it has not been compared with existing therapies. Evidence of its efficacy is not strong.
  
  
  OBJECTIVE
  To compare the efficacy and safety of intralesional Mycobacterium w (Mw) vaccine with that of imiquimod, 5%, cream in the treatment of AGWs, as well as changes in human papillomavirus (HPV)-6 and HPV-11 viral loads.
  
  
  METHODS
  A double-blind randomized clinical trial was conducted in New Delhi, India, between February 2009 and July 2012 and included a 3-month follow-up. Of 159 patients with AGWs who were screened, 89 were randomized.
  
  
  METHODS
  Patients received either imiquimod, 5%, cream and an intralesional vehicle (imiquimod group: 44 patients) or vehicle cream and intralesional Mw vaccine (Mw group: 45 patients).
  
  
  METHODS
  The primary end point was complete clinical remission of visible AGWs. Secondary measures included the percentage of reduction in the surface area of AGWs and viral load for HPV-6 and HPV-11. Viral load was measured by real-time quantitative polymerase chain reaction.
  
  
  RESULTS
  In the intention-to-treat analysis, 59% (n = 26) of the patients in the imiquimod group and 67% (n = 30) of those in the Mw group had complete resolution (P = .52). Eighteen HPV genotypes, including high-risk genotypes, were detected, with no significant differences between the treatment groups (all P > .05). There was a significant decline in the mean viral loads of HPV-6 (from 0.011 × 108 to 0.00000154 × 108 copies/mg of tissue; P = .003) and HPV-11 (from 0.121 × 108 to 0.017 × 108 copies/mg of tissue; P = .03) after treatment in the Mw group but only in the viral load of HPV-6 (from 1.41 × 108 to 0.004 × 108 copies/mg of tissue; P = .01) in the imiquimod group. There was no recurrence of AGWs in patients with complete clearance at the 3-month follow-up and no serious adverse events.
  
  
  CONCLUSIONS
  Imiquimod, 5%, and the Mw vaccine were equally effective in achieving clinical and virologic clearance for HPV-6. A significant decline in the HPV-11 viral load was achieved only with the Mw vaccine. Efficacy and safety of intralesional Mw vaccine is comparable to that of imiquimod, 5%, in treatment of AGWs.
  
  
  BACKGROUND
  ctri.nic.in Identifier: CTRI/2009/091/000055.
authors.affiliation: Department of Microbiology, All India Institute of Medical Sciences, New Delhi.
authors.forename: Pankaj
authors.initials: P
authors.lastname: Kumar
authors.affiliation: Department of Microbiology, All India Institute of Medical Sciences, New Delhi.
authors.forename: Lalit
authors.initials: L
authors.lastname: Dar
authors.affiliation: Department of Dermatology and Venereology, All India Institute of Medical Sciences, New Delhi.
authors.forename: Shashi
authors.initials: S
authors.lastname: Saldiwal
authors.affiliation: Department of Dermatology and Venereology, All India Institute of Medical Sciences, New Delhi.
authors.forename: Sangeeta
authors.initials: S
authors.lastname: Varma
authors.affiliation: Department of Biostatistics, All India Institute of Medical Sciences, New Delhi.
authors.forename: Aashish
authors.initials: A
authors.lastname: Datt Upadhyay
authors.affiliation: Department of Dermatology and Venereology, All India Institute of Medical Sciences, New Delhi.
authors.forename: Deepti
authors.initials: D
authors.lastname: Talwar
authors.affiliation: Department of Dermatology and Venereology, All India Institute of Medical Sciences, New Delhi.
authors.forename: Vinod Kumar
authors.initials: VK
authors.lastname: Sharma
authors.affiliation: Department of Dermatology and Venereology, All India Institute of Medical Sciences, New Delhi.
authors.forename: Kaushal Kumar
authors.initials: KK
authors.lastname: Verma
authors.affiliation: Department of Biostatistics, All India Institute of Medical Sciences, New Delhi.
authors.forename: Sada Nand
authors.initials: SN
authors.lastname: Dwivedi
authors.affiliation: Department of Dermatology and Venereology, All India Institute of Medical Sciences, New Delhi.
authors.forename: Rama
authors.initials: R
authors.lastname: Raj
authors.affiliation: Department of Dermatology and Venereology, All India Institute of Medical Sciences, New Delhi.
authors.forename: Somesh
authors.initials: S
authors.lastname: Gupta
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage* / Q000009:adverse effects; D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000634:Aminoquinolines / Q000008:administration & dosage* / Q000009:adverse effects; D001428:Bacterial Vaccines / Q000008:administration & dosage* / Q000009:adverse effects; D003218:Condylomata Acuminata / Q000188:drug therapy* / Q000821:virology*; D004279:DNA, Viral / Q000032:analysis; D005260:Female; D052140:Human papillomavirus 11 / Q000235:genetics / Q000302:isolation & purification*; D006801:Humans; D000077271:Imiquimod; D015552:Injections, Intralesional; D008297:Male; D063465:Skin Cream / Q000008:administration & dosage; D019562:Viral Load; D055815:Young Adult
chemical_list: D000276:Adjuvants, Immunologic; D000634:Aminoquinolines; D001428:Bacterial Vaccines; D004279:DNA, Viral; C080550:Mycobacterium w vaccine; D000077271:Imiquimod