Immunogenicity and safety of quadrivalent HPV vaccine in women using immunosuppressive drug due to solid organ transplant or rheumatologic disease: study 2: antibody persistence

• Grant number: 19/26554-9
• Support Opportunities: Regular Research Grants
• Start date: September 01, 2020
• End date: August 31, 2022
• 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 ; Karina Takesaki Miyaji ; Maricy Tacla Alves Barbosa ; Vanessa Infante

Abstract

Persons living with HIV/aids, organ transplanted and other immunocompromised individuals have high risk of HPV persistent infection and HPV-related cancers. A previous open label trial, conducted by the authors, evaluated vaccine safety and primary antibody response (one month after the third does) of the HPV quadrivalent vaccine (HPV4v) in 18- to 45-year-old women using immunosuppressors due to solid organ transplantation (kidney, liver, heart or lung) or rheumatologic disease (systemic lupus erythematosus), as compared to healthy women of the same age.Objectives. The primary objective of this study is to evaluate HPV antibody persistence following HPV4V in the women who participated in the previous study; secondary objective is to evaluate the incidence of HPV infection and cervical lesions associated with HPV in this cohort of vaccinated women. Methods. This observational study will include 336 women (105 solid organ transplanted, 113 with Systemic Lupus Erythematosus and 119 healthy /immunocompetent) who completed the previous study, that is, received the full course (three doses) of HPV4 vaccine and collected blood sample for HPV serology 30 days after the third vaccine dose. Antibody persistence will be evaluated by seropositivity rates and antibodies geometric mean titres (GMT) from 18 to 24 months after the third vaccine dose. HPV antibodies will be tested using a VLP specific multiplex HPV serological assay test (multiplexed pseudovirion-based serological assay [PsV-Luminex]). Pap smears and PCR with HPV genotyping will also be performed, from 18 to 24 months following vaccination. (AU)