Quadrivalent HPV vaccine reduces genital lesions and HPV acquisition in men
Simon Collins, HIV i-Base
Heiko Jensen from Praxis presented the results of a large randomised placebo-controlled study in over 4000 men in 18 countries of the Merck quadrivalent HPV vaccine (active against types 6/11/16/18) that was initially studied and approved for use in women. Participants needed to be HIV-negative, HPV seronegative, HPV PCR negative, without genital lesions and to have had fewer than seven sexual partners.
The primary efficacy objective was to demonstrate whether the vaccine reduces the incidence of external genital lesions (EGL) related to HPV6/11/16 or 18.
After approximately two years follow-up, in a per protocol analysis, there were 3 cases of lesions in the active arm vs 31 in the placebo group. This produced efficacy rates of 65.5% (95% CI: 45.8, 78.6) in the ITT and 90.4% (95% CI: 69.2, 98.1) in the per protocol analyses.
The majority of EGL observed were condylomata acuminata; no cases of penile/perianal/perineal intraepithelial neoplasia were observed, though this was a period, follow-up in the study will extend to ten years.
For other endpoints, the rapporteur report noted 89% efficacy in preventing condyloma, 75% efficacy in preventing high grade anal intra-epithelial neoplasia (AIN 2 or more), 78% efficacy in preventing a combined endpoint of AIN or anal cancer over all, and 86% efficacy against persistent infection (defined by positive DNA PCR on 2 samples 4 months apart).
- Jessen H et al. Quadrivalent HPV vaccine efficacy against HPV 6/11/16/18 infection and disease in men. 18th IAS Conference, 1823
July 2010, Vienna. Late breaker oral abstract THLBB0101. http://pag.aids2010.org/Abstracts.aspx?AID=17491
- Garland et al. Quadrivalent vaccine
against Human Papillomavirus to prevent anogenital diseases. N Engl J Med 2007; 356:1928-1943 http://www.nejm.org/doi/full/10.1056/NEJMoa061741