Intralesional Injection of Mycobacterium w Vaccine vs Imiquimod, 5%, Cream in Patients With Anogenital Warts: A Randomized Clinical Trial

IMPORTANCE: 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. DESIGN, SETTING, AND PARTICIPANTS: 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. INTERVENTIONS: 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). MAIN OUTCOMES AND MEASURES: 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 AND RELEVANCE: 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. TRIAL REGISTRATION: ctri.nic.in Identifier: CTRI/2009/091/000055