The burden of human papillomavirus (HPV) in HIV-infected persons and solid organ transplant (SOT) recipients is high. Clinical trials on HPV vaccines in HIV-infected persons and particularly in SOT recipients have been sparse to date, included low numbers of participants and none of them assessed the nine-valent HPV (9vHPV). We investigated the immunogenicity with respect to HPV types 6/11/16/18/31/33/45/52/58 and the safety of the 9vHPV vaccine in HIV-infected persons and recipients of a kidney, lung or heart transplant.
This is a phase III investigator-initiated study in 100 HIV-infected persons (age: 18-45 years) and 171 SOT recipients (age: 18-55 years). The 9vHPV vaccine was administered at day 1, month 2 and month 6. Primary outcome was seroconversion rates to the 9vHPV types at month 7. Secondary outcomes were geometric mean titers (GMTs) and frequency of adverse events (AEs).
All HIV-infected participants seroconverted for all HPV types, but seroconversion ranged from 46% for HPV45 to 72% for HPV58 in SOT recipients. GMTs ranged from 180 to 2985 mMU/ml in HIV-positive participants and from 17 to 170 mMU/ml in SOT recipients, depending on the HPV type. Injection-site AEs occurred in 62% of participants but were mostly mild or moderate in intensity. None of the reported serious adverse events were deemed vaccine-related. No patients died during the study.
Immunogenicity of the 9vHPV vaccine is high in HIV-infected persons but suboptimal in SOT recipients. The vaccine is safe and well tolerated in both groups.

© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

Author