Intralesional Quadrivalent Human Papilloma Virus Vaccine Antigen Injection in the Treatment of Genital Warts: Clinical Evaluation and Effect on Serum and Tissue Interferon Gamma

Abstract Background Introduction: Genital warts or condyloma accuminata - are raised lesions that develop on the skin and mucous membranes due to infection with some types of human papillomavirus (HPV). Human papillomavirus infection is one of the most common sexually transmitted diseases and it is detected at least once in the lifetime of most sexually active people. Despite various treatment options currently available, many patients experience persistent and refractory disease. We sought to evaluate the clinical effectiveness and safety profile of intralesional quadrivalent HPV vaccine (Gardasil) for the treatment of genital warts. Aim of the Work This study aimed to evaluate the clinical efficacy of intralesional quadrivalent Human Papilloma Virus vaccine in the treatment of genital warts and assess its impact on serum and tissue IFNγ before and after treatment. Patients and Methods This study included 10 female patients with ano genital warts. They received intralesional gardasil, (0.3 ml) one injection session every 2 weeks for maximum 4 injection sessions. All the patients were recruited from the Dermatology, venerology outpatient clinic at El Houd el Marsoud Hospital during the period From May 2022 to August 2022. The lab part of the study was done at clinical pathology departement at Ain Shams University. All patients were subjected to clinical examination, photographic examination at first visit before any treatment and at each follow up visit, follow-up of patients were carried out at two-week intervals for 3 months to assess clinical response and complication(s) of injection. IFN-γ was asseyed by enzyme-linked immunosorbent assay (ELISA) using human IFN-γ ELISA Kit. Then quantitative determination of human IFN-γ concentrations were recorded. Results There was a highly significant decrease in the median number of lesions throughout the different sessions as compared to the baseline. The median number of lesions decreased from 14 at the baseline to 12, 10, 8 and 4 at the 2nd, 3rd, 4th sessions and last visit respectively. There was significant decrease in size of the largest injected wart after each treatment session compared to base line. The median size decreased from 1.25 cm at the baseline to 0.4, 0.2, 0.2 and 0.1 cm at the 2nd, 3rd, 4th sessions and last visit respectively. Conclusion the current study showed that intralesional HPV vaccine (gardasil) is an effective treatment modality in treatment of genital warts. INF-γ is considerd a good indicator factor for immune mechanisms needed for wart clearance.