Human papillomavirus (HPV) causes the most prevalent sexually transmitted infections in the world. The nonavalent HPV vaccine (9vHPV) provides protection against 9 high-risk HPV serotypes, responsible for causing approximately 90% of cervical and other HPV-related anogenital cancers, as well as 90% of genital warts. The risk of cancer is substantially increased among immunocompromised patients. Although studies have demonstrated seroprotection among children and adolescents, boys and girls, with the 9vHPV vaccine, the immunogenicity of this vaccine has been poorly explored in immunocompromised children and adolescents (including transplant patients, and those infected with human immunodeficiency virus (HIV)). Several factors, including the immunological consequences of vertically acquired infection, immunosuppressive therapies and age, could lead to an increased risk of infection in children and adolescents who are immunocompromised. Lower immunogenicity in these populations. These children may have a poor response to vaccines and therefore require additional doses. Markers such as CD4/CD8 or torque teno virus (TTV) replication could be linked to immunogenicity and thus serve as predictors of efficacy for routine clinical practice.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
120
All participants will receive the immunization schedule according to guidelines: immunosuppressed patients will receive a three-dose schedule: 0.5 mL intramuscular injection of 9vHPV at entry plus an additional dose at month 2 and month 6. Healthy controls aged 9-14 years will receive a two-dose schedule: 0 and 6 months.
Hospital Universitario La paz
Madrid, Spain
RECRUITINGSeroconversion of subjects from baseline to month 7 (determined by serum anti-HPV antibody titers)
Percentage of subjects seroconverting from baseline to month 7
Time frame: From baseline to month 7
Seroconversion of subjects from baseline to month 12 (determined by serum anti-HPV antibody titers)
Percentage of subjects maintaining antibody titers 12 months after immunization.
Time frame: From baseline to month 12
Seroconversion of subjects from baseline to month 18 (determined by serum anti-HPV antibody titers)
Percentage of subjects maintaining antibody titers 18 months after immunization.
Time frame: From baseline to month 18
Ratio of geometric mean serum antibody titers (GMTs)
GMTs from baseline to month 7
Time frame: From baseline to month 7
Delta of geometric mean serum antibody titers
Delta of geometric mean serum antibody titers from 1 to 12 months after immunization.
Time frame: From 1 to 12 months
Percentage of subjects seroconverting from baseline to month 7
Percentage of subjects seroconverting from baseline to month 7 in each of the study populations.
Time frame: From baseline to month 7
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