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

Abstract

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)