A randomized trial of immunotherapy for persistent genital warts

Abstract

Aim: To determine whether immunotherapy with HPV6 L1 virus like particles (VLPs) without adjuvant (VLP immunotherapy) reduces recurrence of genital warts following destructive therapy.Trial design: A randomized placebo controlled blinded study of treatment of recurrent genital warts amenable to destructive therapy, conducted independently in Australia and China.Methods: Patients received conventional destructive therapy of all evident warts together with intramuscular administration of 1, 5 or 25 mg of VLP immunotherapy, or of placebo immunotherapy (0.9% NaCl), as immunotherapy at week 0 and week 4. Primary outcome, assessed at week 8, was recurrence of visible warts.Results: Of 33 protocol compliant Brisbane recipients of placebo immunotherapy, 11 were disease free at two months, and a further 9 demonstrated reduction of . 50% in total wart area. Wart area reduction following destructive treatment correlated with prior duration of disease. Among 102 protocol compliant Brisbane recipients of VLP immunotherapy, disease reduction was significantly greater than among the placebo immunotherapy (50% ± s.e.m. 7%) recipients for subjects receiving 5 mg or 25 mg of VLP immunotherapy/dose (71% ± s.e.m.7%) but not for those receiving 1 mg VLP immunotherapy/dose (42% ± 7%). Of 52 protocol compliant placebo immunotherapy recipients in Wenzhou, 37 were disease free at two months, and a further 8 had . 50% disease reduction. Prior disease duration was much shorter in Wenzhou subject (8.1 ± 1.1 mo) than in Brisbane subjects (53.7 ± 5.5 mo). No significant reduction in mean wart area was observed for the 168 Wenzhou protocol compliant subjects who also received VLP immunotherapy.Conclusions: This study confirms the findings in a previous open label trial that administration of VLP immunotherapy may assist in clearance of recurrent genital warts in patients for whom destructive therapy is unsuccessful and that unsuccessful destructive therapy is more common with increasing prior disease duration.

Opportunities and challenges for human papillomavirus vaccination in cancer

“…The role of nAbs as the primary effector of protection is widely accepted; however, this concept does not consider the contribution of cellular immunity and a potential therapeutic benefit. Vaccination with L1 VLP does not confer a therapeutic benefit in most disease models or clinical studies 79 , although there have been hints of activity 80 . L1 VLP immunization does induce a robust L1-specific CD8 + T cell response, but basal keratinocytes harbouring HPV do not detectably express L1 and thus presumably escape this response.…”

Could the human papillomavirus vaccine prevent recurrence of ano-genital warts?: a systematic review and meta-analysis

“…The former concept of 'therapeutic' vaccines directed toward stimulating T-cell responses against HPV has been explored previously with apparently some level of clearance in AGWs, [25][26][27][28] although other authors obtained opposite outcomes. 29 This new concept of vaccine as a secondary prevention measure in AGWs is a relatively novel concept.…”

A systematic review and meta-analysis on the effectiveness and safety of Tribulus Terrestris in male fertility problems: examining semen parameters and erectile function

“…Genital warts have quality of life (20)(21)(22)(23) and significant socio-economic impact, as it is the most common sexually transmitted infections (2)(3)(4)24), although the presence of national vaccination programs. Various highly aggressive methods have been used for treatment of GW but can lead to sequelae like scars and deformations with a high recurrence rate (25) and can be associated with pain and HPV transmission, if HPV particles are present in the smoke plume produced by destructive therapies (26).…”