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ORIGINAL RESEARCH article

Front. Cell. Infect. Microbiol.
Sec. Virus and Host
Volume 14 - 2024 | doi: 10.3389/fcimb.2024.1452916
This article is part of the Research Topic Papillomaviruses, immunity, and tumour development View all 7 articles

Quadrivalent HPV (4vHPV) vaccine immunogenicity and safety in women using immunosuppressive drugs due to solid organ transplant

Provisionally accepted
Karina T. Miyaji Karina T. Miyaji 1*Vanessa Infante Vanessa Infante 1Camila M. Picone Camila M. Picone 1Joakim Dillner Joakim Dillner 2Hanna Kann Hanna Kann 3Carina Eklund Carina Eklund 2José Eduardo Levi José Eduardo Levi 4Ana Carolina S. Oliveira Ana Carolina S. Oliveira 4Amanda N. Lara Amanda N. Lara 1Lyca S. Kawakami Lyca S. Kawakami 4Maricy Tacla Maricy Tacla 1Cristina P. Castanheira Cristina P. Castanheira 1Philippe Mayaud Philippe Mayaud 5Ana Marli C. Sartori Ana Marli C. Sartori 4
  • 1 Hospital das Clinicas da FMUSP, SAO PAULO, Brazil
  • 2 Karolinska Institutet (KI), Solna, Stockholm, Sweden
  • 3 University of Gothenburg, Gothenburg, Västergötland, Sweden
  • 4 University of São Paulo, São Paulo, Rio Grande do Sul, Brazil
  • 5 London School of Hygiene and Tropical Medicine, University of London, London, London, United Kingdom

The final, formatted version of the article will be published soon.

    Introduction: Immunocompromised persons are at high risk of persistent Human Papilloma Virus (HPV) infection and associated diseases. Few studies evaluated HPV vaccines in immunocompromised persons. This study aimed to evaluate the quadrivalent HPV vaccine (4vHPV) immunogenicity and safety in solid organ transplant (SOT) recipients, in comparison to immunocompetent women (IC).Methods: Open-label clinical trial that enrolled SOT recipients and immunocompetent women aged 18 to 45 years. All participants received three doses of 4vHPV vaccine. Blood samples were drawn for evaluation of immune responses at baseline and one month after the third vaccination. Seroconversion rates and antibody geometric mean concentration (GMC) against HPV 6,11,16,18,31, 35, 52 and 58 were measured with in-house multiplexed serology assay (xMAP technology). Follow-up for the local and systemic adverse events (AEs) continued for seven days after each vaccination. Severe AEs were evaluated throughout the study.Results: 125 SOT and 132 immunocompetent women were enrolled; 105 (84%) SOT and 119 (90%)] immunocompetent women completed the study. At baseline, HPV seropositivity was not significantly different between groups. Seroconversion rates were significantly lower in SOT (HPV18, 57%; HPV6 and 16, 69%; and HPV11, 72%) than in immunocompetent women (100% seroconversion to all vaccine types) (p<0.001). Antibody GMCs of all four HPV vaccine types were also significantly lower in SOT (p<0.001). Pain in the injection site and headache were the most frequent adverse event in both groups. Local pain was more frequent in immunocompetent women than in SOT recipients. Rates of other AEs were comparable in both groups.Conclusions: 4vHPV vaccine was well-tolerated by SOT recipients. We found strong evidence of lower humoral immune responses to 4vHPV vaccine in SOT compared to immunocompetent women, which strengthen recommendation of routine cervical cancer screening in SOT recipients regardless of HPV vaccination status.

    Keywords: Papillomavirus Vaccines, Immunogenicity, Safety, Immunosuppression, solid organ transplant, cancer prevention

    Received: 21 Jun 2024; Accepted: 19 Aug 2024.

    Copyright: © 2024 Miyaji, Infante, Picone, Dillner, Kann, Eklund, Levi, Oliveira, Lara, Kawakami, Tacla, Castanheira, Mayaud and Sartori. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Karina T. Miyaji, Hospital das Clinicas da FMUSP, SAO PAULO, Brazil

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.