1 November 2018
The HIPvac Trial aims to compare the efficacy of imiquimod cream versus podophyllotoxin cream for the treatment of external anogenital warts, and determine if the addition of quadrivalent HPV vaccine affects either the clearance or recurrence rate. The research is funded by NIHR HTA.
It is a randomised, controlled partially blinded 2 x 2 factorial trial. Participants will be simultaneously randomised to one of two topical treatments, and vaccine or placebo. The four groups, therefore, are:
A. imiquimod cream plus HPV vaccine;
B. podophyllotoxin cream plus HPV vaccine;
C. imiquimod cream plus saline placebo injection.
D. podophyllotoxin cream plus saline placebo injection
The primary outcome is a composite endpoint of wart clearance within 16 weeks of starting treatment and remaining wart-free between 16 and 48 weeks. This will capture both the initial clearance efficacy as well as the impact on relapse or recurrence.
The trial was set-up in 22 centres across the UK and recruited 504 participants. HIPvac is now closed.
Gilson R, Nugent D, Bennett K, Doré CJ, Murray ML, Meadows J, Haddow L J, Lacey C, Sandmann F, Jit M, Soldan K, Tetlow M, Caverly E, Nathan M, Copas A J. Imiquimod versus podophyllotoxin, with and without human papillomavirus vaccine, for anogenital warts: the HIPvac factorial RCT. Health Technology Assessment 2020;24(47)
Gilson R, Bennett K, Sandmann F, Murray M, Doré CJ, Haddow L, Nugent D, Lacey C, Jit M, Soldan K, Caverly E, Nathan M, Copas A. Efficacy and cost-effectiveness of qHPV vaccine with imiquimod or podophyllotoxin for patients with anogenital warts (HIPvac). (Abstract) Sexually Transmitted Diseases 2019;95(Suppl 1), A50-A51.
- Murray ML, Meadows J, Doré CJ, Copas AJ, Haddow LJ, Lacey C, Jit M, Soldan K, Bennett K, Tetlow M, Nathan M, Gilson R. Human papillomavirus infection: protocol for a randomised controlled trial of imiquimod cream (5%) versus podophyllotoxin cram (0.15%), in combination with quadrivalent human papillomavirus or control vaccination in the treatment and prevention of recurrence of anogenital warts (HIPvac trial). BMC Medical Research Methodology 2018;18:125.