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Intralesional Mycobacterium w vaccine cleared HPV, anogenital warts
Intralesional injection of the Mycobacterium w vaccine appears to be equivalent to imiquimod 5% in yielding clinical and virological clearance of the HPV-6 in patients with anogenital warts, according to recent findings published in JAMA Dermatology.
In a double-blind, randomized clinical trial, researchers evaluated 159 patients recruited from the All India School of Medical Sciences, New Delhi. Patients were required to be at least 12 years of age, have one or more anogenital warts (AGW) covering a surface area of 10 mm2 or greater, appear otherwise healthy and not have undergone treatment within the previous 4 weeks. The researchers photographed the lesions at baseline and then once a month for the duration of the 3-month follow-up. Patients were seen for examination at baseline, once every 2 weeks for up to 20 weeks (treatment phase), then monthly for 3 months. A total of 89 patients were randomly assigned to treatment with imiquimod 5% cream and an intralesional vehicle (imiquimod group, n=44) or vehicle cream and intralesional Mycobacterium w (Mw) vaccine.
The researchers defined the study’s primary endpoint as complete clinical resolution of AGWs. Secondary endpoints were percentage of decrease in AGW surface area and viral load for HPV-6 and HPV-11. Real-time quantitative PCR was used to determine viral load.
An intention-to-treat analysis revealed that 26 patients (59%) in the imiquimod group and 30 patients (67%) in the Mw group achieved complete remission (P=.52). The researchers detected 18 HPV genotypes, with no significant differences between the treatment groups.
Patients in the Mw group demonstrated a significant decrease in mean viral loads of HPV-6 (from 0.011 x 108 to 0.00000154 x 108 copies/mg of tissue; P=.003) and HPV-11 (from 0.121 × 108 to 0.017 × 108 copies/mg of tissue; P =.03). Patients in the imiquimod group experienced viral load decreases in HPV-6 only (from 1.41 × 108 to 0.004 × 108 copies/mg of tissue; P=.01). Patients who achieved complete remission at the 3-month follow-up did not experience recurrences or serious adverse events, according to the findings. Adverse events included local immunologic or irritant reactions, or systemic events such as fever or ache.
“Although it is invasive and associated with local immunologic reactions, intralesional Mw vaccine therapy is as effective as imiquimod 5% in the treatment of AGWs and results in elimination of HPV in the lesion,” the researchers concluded. “We will endeavor to further study the efficacy of the Mw vaccine in AGWs that fail to respond to imiquimod 5% and other conventional therapies.”
Disclosure: The researchers report no relevant financial disclosures.