HPV vaccine for cancer and wart prevention.

Evidence Three large international RCTs in females aged 15 to 26 used modified intention-to-treat analysis (including patients with positive test results for HPV at baseline) for all HPV lesions.1-4 • Quadrivalent vaccine (HPV 6, 11, 16, and 18): -FUTURE 1 trial1 following 5455 women for 4 years found decreased external genital lesions (3.8% vs 5.7% [placebo]; number needed to vaccinate [NNV] = 53) and CIN of grade 2 or 3 (6.6% vs 7.1% [placebo]; not statistically significant). -FUTURE 2 trial2 following 12 167 women for 3 years found decreased CIN of grade 2 or 3 (3.6% vs 4.4% [placebo]; NNV = 125). -FUTURE 1 and 2 combination3 trial following women for 4 years found decreased external genital lesions (1.5% vs 4% [placebo]; NNV = 40); CIN of grade 2 or 3 was not reported. • Bivalent vaccine (HPV 16 and 18 vaccine)4: -Trial following 18 644 women for 4 years found decreased CIN of 2 or 3 (3.3% vs 4.9% [placebo]; NNV = 63). • Smaller studies showed similar effects.5,6 -All studies excluded those who were pregnant, had previous abnormal Papanicolaou test results or genital warts, or had more than 4 to 6 lifetime sexual partners. All studies were funded by vaccine manufacturers. Similar relative efficacy was seen for condyloma in males aged 16 to 26.7