PMID- 33373429
OWN - NLM
STAT- MEDLINE
DCOM- 20210806
LR  - 20210806
IS  - 1537-6591 (Electronic)
IS  - 1058-4838 (Linking)
VI  - 73
IP  - 3
DP  - 2021 Aug 2
TI  - Immunogenicity and Safety of the 9-Valent Human Papillomavirus Vaccine in Solid 
      Organ Transplant Recipients and Adults Infected With Human Immunodeficiency Virus 
      (HIV).
PG  - e661-e671
LID - 10.1093/cid/ciaa1897 [doi]
AB  - 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.
CI  - (c) 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.
FAU - Boey, Lise
AU  - Boey L
AUID- ORCID: 0000-0001-9623-4482
AD  - Leuven University Vaccinology Centre, Department of Public Health and Primary 
      Care, KU Leuven, Leuven, Belgium.
FAU - Curinckx, Ans
AU  - Curinckx A
AD  - Leuven University Vaccinology Centre, Department of Public Health and Primary 
      Care, KU Leuven, Leuven, Belgium.
FAU - Roelants, Mathieu
AU  - Roelants M
AUID- ORCID: 0000-0002-3749-0475
AD  - Leuven University Vaccinology Centre, Department of Public Health and Primary 
      Care, KU Leuven, Leuven, Belgium.
FAU - Derdelinckx, Inge
AU  - Derdelinckx I
AD  - Department of Microbiology and Immunology, KU Leuven, Leuven, Belgium.
AD  - Department of General Internal Medicine, University Hospitals Leuven, Leuven, 
      Belgium.
FAU - Van Wijngaerden, Eric
AU  - Van Wijngaerden E
AD  - Department of Microbiology and Immunology, KU Leuven, Leuven, Belgium.
AD  - Department of General Internal Medicine, University Hospitals Leuven, Leuven, 
      Belgium.
FAU - De Munter, Paul
AU  - De Munter P
AD  - Department of Microbiology and Immunology, KU Leuven, Leuven, Belgium.
AD  - Department of General Internal Medicine, University Hospitals Leuven, Leuven, 
      Belgium.
FAU - Vos, Robin
AU  - Vos R
AD  - 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.
FAU - Kuypers, Dirk
AU  - Kuypers D
AD  - Department of Microbiology and Immunology, KU Leuven, Leuven, Belgium.
AD  - Department of Nephrology and Renal Transplantation, University Hospitals Leuven, 
      Leuven, Belgium.
FAU - Van Cleemput, Johan
AU  - Van Cleemput J
AD  - Department of Cardiology, University Hospitals Leuven, Leuven, Belgium.
FAU - Vandermeulen, Corinne
AU  - Vandermeulen C
AD  - Leuven University Vaccinology Centre, Department of Public Health and Primary 
      Care, KU Leuven, Leuven, Belgium.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Clin Infect Dis
JT  - Clinical infectious diseases : an official publication of the Infectious Diseases 
      Society of America
JID - 9203213
RN  - 0 (Antibodies, Viral)
RN  - 0 (Papillomavirus Vaccines)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Antibodies, Viral
MH  - HIV
MH  - *HIV Infections/complications
MH  - Humans
MH  - Immunogenicity, Vaccine
MH  - Middle Aged
MH  - *Organ Transplantation
MH  - *Papillomavirus Infections/complications/prevention & control
MH  - *Papillomavirus Vaccines
MH  - Young Adult
OTO - NOTNLM
OT  - 9-valent HPV vaccine
OT  - human papillomavirus
OT  - persons living with HIV
OT  - solid organ transplant recipients
EDAT- 2020/12/30 06:00
MHDA- 2021/08/07 06:00
CRDT- 2020/12/29 17:09
PHST- 2020/11/11 00:00 [received]
PHST- 2020/12/30 06:00 [pubmed]
PHST- 2021/08/07 06:00 [medline]
PHST- 2020/12/29 17:09 [entrez]
AID - 6054974 [pii]
AID - 10.1093/cid/ciaa1897 [doi]
PST - ppublish
SO  - Clin Infect Dis. 2021 Aug 2;73(3):e661-e671. doi: 10.1093/cid/ciaa1897.