V501-020
Quadrivalent HPV vaccine versus placebo in young men, anal intraepithelial neoplasia substudy in men who have sex with men (V501-020; ClinicalTrials.gov official title: An Investigational Vaccine in Reducing the Incidence of Anogenital Warts in Young Men)
Phase 3N = 602NCT00090285
- Population
- Healthy men who have sex with men aged 16 to 26 years (anal substudy of a trial in 4065 men)
- Design
- Substudy of a larger double-blind, placebo-controlled randomised trial in men (4065 randomised, per the FDA review and ClinicalTrials.gov). In the substudy 602 healthy men who have sex with men, aged 16 to 26, were randomised to quadrivalent HPV vaccine or placebo (aluminium-adjuvant-containing saline per the FDA review) and underwent extended anal surveillance (rectal examination, anal cytology, anal HPV PCR, anoscopy with biopsy as indicated). Primary efficacy objective: prevention of anal intraepithelial neoplasia or anal cancer related to infection with HPV 6, 11, 16 or 18. Efficacy was analysed in intention-to-treat and per-protocol efficacy populations.
- Primary endpoint
- Vaccine-type AIN or anal cancer
- Arms
- Placebo (control): Placebo (aluminium-adjuvant-containing saline per the FDA review), three doses at day 1, month 2 and month 6 (base-study schedule per Goldstone 2022)
- Quadrivalent HPV vaccine (experimental): Quadrivalent HPV (types 6, 11, 16, 18) vaccine, three doses at day 1, month 2 and month 6 (base-study schedule per Goldstone 2022)
- People
- Palefsky JM