Immunogenicity and Safety of the 9-Valent Human Papillomavirus Vaccine in Solid Organ Transplant Recipients and Adults Infected With Human Immunodeficiency Virus (HIV)
| Autor: | Corinne Vandermeulen, Ans Curinckx, Dirk Kuypers, Johan Van Cleemput, Mathieu Roelants, Paul De Munter, Eric Van Wijngaerden, Inge Derdelinckx, Lise Boey, Robin Vos |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
Microbiology (medical)
nine-valent vaccine Adult medicine.medical_specialty Human papillomavirus Adolescent Human immunodeficiency virus (HIV) Human Papilloma Virus Vaccine HIV Infections HPV vaccines 030230 surgery medicine.disease_cause Antibodies Viral HIV-infected persons 03 medical and health sciences Young Adult 0302 clinical medicine Immunogenicity Vaccine Internal medicine medicine Humans 030212 general & internal medicine Papillomavirus Vaccines Seroconversion Adverse effect business.industry Immunogenicity Papillomavirus Infections HIV solid organ transplant recipients Organ Transplantation Middle Aged Clinical trial Titer Infectious Diseases business |
| Zdroj: | Clinical infectious diseases : an official publication of the Infectious Diseases Society of America. 73(3) |
| ISSN: | 1537-6591 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|