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Immunogenicity and safety of HPV vaccine in immunosuppressed women due to solid organ transplant and rheumatologic disease. Study 1: Evaluation of primary imune response to vaccination

Grant number: 16/06942-6
Support Opportunities:Regular Research Grants
Duration: May 01, 2017 - October 31, 2019
Field of knowledge:Health Sciences - Medicine - Medical Clinics
Principal Investigator:Ana Marli Christovam Sartori
Grantee:Ana Marli Christovam Sartori
Host Institution: Faculdade de Medicina (FM). Universidade de São Paulo (USP). São Paulo , SP, Brazil
Associated researchers:José Eduardo Levi ; Maricy Tacla Alves Barbosa


Background. Persons living with HIV/aids, organ transplanted and other immunocompromised individuals have high risk of HPV persistent infection and HPV-related cancers. Three efficacious and safe HPV vaccines (bivalent, quadrivalent and nonovalent) are currently available. Few studies evaluated immunogenicity and safety of HPV vaccines in immunocompromised persons.Objectives. The aim of this study is to evaluate immunogenicity and safety of quadrivalent HPV vaccine (HPV4V) in immunocompromised women due to solid organ transplant or rheumatologic diseases aged 18 to 45 years, in comparison to healthy women of the same age. Methods. This open label trial will include 375 participants, 125 solid organ transplanted women and 125 women with rheumatologic condition in use of immunosuppresssive therapy, and 125 healthy (immunocompetent) women. All participants will receive three doses of HPV 4V vaccine (at 0, 2 and 6 months) and will be followed-up for 7 months (1 month after the third vaccine dose). Primary antibody responses to vaccination (seroconversion rates and antibodies geometric mean titres, GMT) will be evaluated one month after the third vaccine dose (M7). HPV antibodies will be tested using a VLP specific multiplex HPV serological assay test (multiplexed pseudovirion-based serological assay [PsV-Luminex]). Solicited and unsolicited, local and systemic adverse events (AE) following immunization will be accessed in all participants from the moment immediately after to 7 days after vaccine administration. (AU)

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Scientific publications
(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)
MIYAJI, KARINA TAKESAKI; INFANTE, VANESSA; PICONE, CAMILA DE MELO; LEVI, JOSE EDUARDO; SOARES DE OLIVEIRA, ANA CAROLINA; LARA, AMANDA NAZARETH; TACLA, MARICY; DILLNER, JOAKIM; KANN, HANNA; EKLUND, CARINA; et al. Human Papillomavirus (HPV) seroprevalence, cervical HPV prevalence, genotype distribution and cytological lesions in solid organ transplant recipients and immunocompetent women in Sao Paulo, Brazil. PLoS One, v. 17, n. 1, p. 12-pg., . (16/06942-6)

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