NOTE

🌱 created from: epidemiology_of_anal_cancer

hpv_vaccination

Quadrivalent HPV Vaccine (qHPV) for Prevention of Anal Intraepithelial Neoplasia in Men Who Have Sex with Men

Information

• Design: Double-blind, randomized substudy
• Number of patients: 602 healthy men who have sex with men, 16 to 26 years of age
• Agent: Quadrivalent HPV vaccine (qHPV)
• Endpoints:
  • Primary: Prevention of anal intraepithelial neoplasia or anal cancer related to infection with HPV-6, 11, 16, or 18
  • Secondary: Rates of adverse events
• Trial Name or NCT Number: NCT00090285

Results

• Efficacy:
  • Intention-to-treat population: 50.3% (95% CI, 25.7 to 67.2) against anal intraepithelial neoplasia associated with HPV-6, 11, 16, or 18
  • Per-protocol efficacy population: 77.5% (95% CI, 39.6 to 93.3) against anal intraepithelial neoplasia associated with HPV-6, 11, 16, or 18
• Rates of anal intraepithelial neoplasia:
  • Intention-to-treat population: 17.5 per 100 person-years in the placebo group, 13.0 per 100 person-years in the vaccine group
  • Per-protocol efficacy population: 8.9 per 100 person-years in the placebo group, 4.0 per 100 person-years in the vaccine group
• Grade 2 or 3 anal intraepithelial neoplasia:
  • Intention-to-treat population: Reduced by 54.2% (95% CI, 18.0 to 75.3)
  • Per-protocol efficacy population: Reduced by 74.9% (95% CI, 8.8 to 95.4)
• Persistent anal infection with HPV-6, 11, 16, or 18:
  • Intention-to-treat population: Reduced by 59.4% (95% CI, 43.0 to 71.4)
  • Per-protocol efficacy population: Reduced by 94.9% (95% CI, 80.4 to 99.4)
• Safety: No vaccine-related serious adverse events were reported.

Summary The quadrivalent HPV vaccine (qHPV) was found to be effective in reducing the rates of anal intraepithelial neoplasia, including grade 2 or 3, among men who have sex with men. The vaccine had a favorable safety profile and may help to reduce the risk of anal cancer.

(NEJM 2011;365:1576)

Palefsky JM. HPV Vaccine against Anal HPV Infection and Anal Intraepithelial Neoplasia. The New England Journal of Medicine. Published October 27, 2011. Accessed September 4, 2024. https://www.nejm.org/doi/full/10.1056/NEJMoa1010971