Because HIV-infected adults are at risk of developing anal and oropharyngeal cancer, a phase 3 randomized trial was done to test the effectiveness of a vaccine against human papillomavirus infection. The vaccine proved ineffective in preventing new anal HPV infections or improving clinical outcomes among patients with high-grade squamous intraepithelial lesions (HSIL).
- The phase 3 placebo controlled double-blind study randomized 575 adults aged ≥27 years.
- The quadrivalent HPV vaccine was only efficacious in 22% of patients for preventing persistent anal infection.
- Efficacy was 0% for its ability to improve HSIL outcomes.
- The efficacy of the vaccine was 88% for preventing persistent oral HPV infection but only 32% efficacious for 6-month persistent oral HPV infection or detection at the final visit.
Wilkin TJ, Chen H, Cespedes MS, et al. A randomized, placebo-controlled trial of the quadrivalent HPV vaccine in HIV-infected adults age 27 years or older: AIDS clinical trials group protocol A5298. [Published online ahead of print April 5, 2018]. Clin Infect Dis. doi:10.1093/cid/ciy274.
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