A phase 1b multicentre study of HPV6 L1 virus-like particles as adjunct immunotherapy for anogenital warts

Jardine, D., Lu, J., Palmer, C., Pang, J., Chuah, J. and Frazer, I. (2009). A phase 1b multicentre study of HPV6 L1 virus-like particles as adjunct immunotherapy for anogenital warts. In: Sexual Health. Australasian Sexual Health Conference 2009, Gold Coast, Queensland, Australia, (356-357). 7 - 9 September 2009.

Author Jardine, D.
Lu, J.
Palmer, C.
Pang, J.
Chuah, J.
Frazer, I.
Title of paper A phase 1b multicentre study of HPV6 L1 virus-like particles as adjunct immunotherapy for anogenital warts
Conference name Australasian Sexual Health Conference 2009
Conference location Gold Coast, Queensland, Australia
Conference dates 7 - 9 September 2009
Proceedings title Sexual Health   Check publisher's open access policy
Journal name Sexual Health   Check publisher's open access policy
Publisher CSIRO Publishing
Publication Year 2009
Sub-type Oral presentation
ISSN 1448-5028
Volume 6
Issue 4
Start page 356
End page 357
Total pages 1
Language eng
Abstract/Summary A phase 1b randomised placebo controlled blinded dose ranging study of HPV6 L1 Virus-Like Particles (VLPs) as therapy for genital warts. Men (201) and women (171) ages 18–65 years with anogenital warts present for 3 months and recurrent after prior treatment were treated with destructive therapy of their anogenital warts and two injections of HPV6b VLPs without adjuvant (1 mcg, 5 mcg, 25 mcg) or placebo, 4 weeks apart. The primary outcome, wart resolution/recurrence after 2 months, was evaluated per protocol at each of two recruitment sites, and separately for males and females. Overall, there was a significant difference in wart outcome between the two sites. One site used only cautery as destructive therapy and the treatment success rate in the placebo group (37/52 complete resolution (CR) = 71%), was not significantly improved by immunotherapy. The other site used a range of treatment modalities, and a lower treatment success rate was observed in the placebo group (11/33 CR = 33%). At this recruitment site, outcome for males but not females was significantly improved by immunotherapy (n = 87) in a vaccine dose dependent fashion (CR/PR (partial resolution) v. NR (no resolution); X2 for trend 11.2; 1DF P < 0.001). Post hoc analysis by treatment mode was consistent with the hypothesis that improvement with immunotherapy was confined to subjects receiving destructive treatment other than cautery. This study confirms the findings of a previous open label study that immunotherapy with HPV6b VLPs without adjuvant can improve the probability of resolution of wart disease following therapy, and suggests that the benefit may be confined to those receiving non-cautery destructive therapy.
Subjects 1117 Public Health and Health Services
Q-Index Code EX
Q-Index Status Provisional Code
Institutional Status Unknown
Additional Notes Oral presentation number: 19

Document type: Conference Paper
Collection: School of Medicine Publications
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Created: Sun, 29 Nov 2009, 00:01:10 EST