Lise Boey1, Ans Curinckx1, Mathieu Roelants1, Inge Derdelinckx2,3, Eric Van Wijngaerden2,3, Paul De Munter2,3, Robin Vos4, Dirk Kuypers2,5, Johan Van Cleemput6, Corinne Vandermeulen1. 1. Leuven University Vaccinology Centre, Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium. 2. Department of Microbiology and Immunology, KU Leuven, Leuven, Belgium. 3. Department of General Internal Medicine, University Hospitals Leuven, Leuven, Belgium. 4. Department of Respiratory Diseases, University Hospitals Leuven, Leuven, Belgium, and Department CHROMETA (Chronic Diseases, Metabolism and Aging), BREATHE (Laboratory of Respiratory Diseases and Thoracic Surgery), KU Leuven, Leuven, Belgium. 5. Department of Nephrology and Renal Transplantation, University Hospitals Leuven, Leuven, Belgium. 6. Department of Cardiology, University Hospitals Leuven, Leuven, Belgium.
Abstract
BACKGROUND: The burden of human papillomavirus (HPV) in human immunodeficiency virus (HIV)-infected persons and solid organ transplant (SOT) recipients is high. Clinical trials on HPV vaccines in persons living with HIV and particularly in SOT recipients have been sparse to date, included low numbers of participants, and none of them assessed the 9-valent HPV (9vHPV) vaccine. We investigated the immunogenicity with respect to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 and the safety of the 9vHPV vaccine in persons living with HIV and recipients of a kidney, lung, or heart transplant. METHODS: This is a phase III investigator-initiated study in 100 persons living with HIV (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. CONCLUSIONS: Immunogenicity of the 9vHPV vaccine is high in persons living with HIV but suboptimal in SOT recipients. The vaccine is safe and well tolerated in both groups.
BACKGROUND: The burden of human papillomavirus (HPV) in human immunodeficiency virus (HIV)-infected persons and solid organ transplant (SOT) recipients is high. Clinical trials on HPV vaccines in persons living with HIV and particularly in SOT recipients have been sparse to date, included low numbers of participants, and none of them assessed the 9-valent HPV (9vHPV) vaccine. We investigated the immunogenicity with respect to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 and the safety of the 9vHPV vaccine in persons living with HIV and recipients of a kidney, lung, or heart transplant. METHODS: This is a phase III investigator-initiated study in 100 persons living with HIV (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-infectedparticipants 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. CONCLUSIONS: Immunogenicity of the 9vHPV vaccine is high in persons living with HIV but suboptimal in SOT recipients. The vaccine is safe and well tolerated in both groups.
Authors: Lisa Staadegaard; Minttu M Rönn; Nirali Soni; Meghan E Bellerose; Paul Bloem; Marc Brisson; Mathieu Maheu-Giroux; Ruanne V Barnabas; Melanie Drolet; Philippe Mayaud; Shona Dalal; Marie-Claude Boily Journal: EClinicalMedicine Date: 2022-08-03