Background
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.
Methods
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).
Results
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.
Conclusion
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.