Journal
CLINICAL INFECTIOUS DISEASES
Volume 67, Issue 9, Pages 1339-1346Publisher
OXFORD UNIV PRESS INC
DOI: 10.1093/cid/ciy274
Keywords
human papillomavirus; HIV-1 infection; anal dysplasia; HPV vaccination; oral HPV infection
Categories
Funding
- National Institute of Allergy and Infectious Diseases (NIAID) through the AIDS Clinical Trials Group [UM1 AI068634, UM1 AI068636, UM1 AI106701]
- National Institute of Dental and Craniofacial Research at the NIH [U01 AI068636]
- National Institutes of Health [U01AI068636]
- NIAID
- NIDCR
- NIH [UM1 AI068636, P30 AI027757, UM1 AI069494, UM1 AI069419, UL1 TR000457, UM1 AI069511, UL1 TR000042, AI 069432, UM1 AI069423, UL1 TR001111, P30 AI50410, UM1 AI069532, U01 AI06947602]
- [U01 AI069503]
- [UM1 AI069470]
- [UL1 TR000040]
- [UM1 AI069432]
- [UL1 TR001082]
- [U01 AI069471]
- [UM1 AI069439]
- [UM1 AI069471]
- [UM1 AI069503]
- [UM1 AI069556]
- [UM1 AI069496]
- [UM1 AI069415]
- [UM1 AI069424]
- [UM1 AI069412]
- [U01 A1069472]
- [UM1 AI069472]
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Background. Adults living with human immunodeficiency virus (HIV) are at increased risk for anal and oropharyngeal cancer caused by human papillomavirus (HPV). The efficacy of HPV vaccines in this population is unknown. Methods. In this phase 3, double-blind, randomized, controlled trial, we assigned HIV-infected adults aged >= 27 years to the quadrivalent HPV (types 6, 11, 16, 18) vaccine or placebo (1:1) stratified by sex and presence of anal high-grade squamous intraepithelial lesions on biopsy (bHSIL). The primary endpoint was vaccine efficacy against incident persistent anal infection with quadrivalent vaccine types or single detection at the final visit that were not present at baseline. Secondary endpoints included vaccine efficacy for anal bHSIL after week 52, persistent oral HPV infection. Results. A total of 575 participants were randomized. The Data and Safety Monitoring Board stopped the study early due to futility. Vaccine efficacy was 22% (95.1% confidence interval [CI], -31%, 53%) for prevention of persistent anal infection or single detection at the final visit, 0% (95% CI -44%, 31%) for improving bHSIL outcomes and 88% (95.1% CI 2%, 98%) for preventing persistent oral HPV infection, but was 32% (95.1% CI -80%, 74%) for 6-month persistent oral HPV infection or single detection at the final visit. Conclusions. These results do not support HPV vaccination of HIV-infected adults aged >= 27 years to prevent new anal HPV infections or to improve anal HSIL outcomes. However, our data suggest a role for prevention of oral HPV infections, but this finding should be confirmed in future studies.
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