Infection by HPV 6, 11, 16, 18
Conditions
Interventions
Trade Name: GARDASIL
Pharmaceutical Form: Suspension for injection in pre-filled syringe
Sponsors
CHU de Bordeaux
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Female gender - Age = 9 years - Solid organ transplantation: kidney, liver, heart, lung, intestinal or combined transplant; or systemic lupus erythematosus or other systemic immune disease - Transplantation or diagnosis of lupus since more than 6 months - Immunosuppressant treatment by anti-metabolites or calcineurin inhibitors, with or without associated corticosteroids - Minimum required period of 3 months considered as stable after transplantation or without relapse of lupus according to physician evaluation - In case of sexual activity (assessed by auto-declaration): onset less than one year before inclusion - Written informed consent signed by the investigator and the legal representatives of the patient, and assent by the patient Are the trial subjects under 18? yes Number of subjects for this age range: 35 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Male gender - Pregnancy - Age 18 years - Previous HPV vaccination - Immunosuppressive treatment by anti-TNF (adalimumab, etanercept, infliximab) or monoclonal antibodies (rituximab, anakinra, abatacept) during the last 3 months - Active malignancy - Active opportunistic infection - HIV infection - Concurrent clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the persistence of immunological response to tetravalent HPV vaccine at 18 months after first dose of vaccine;Secondary Objective: - To study immunologic response at M7, M18, and M36 - To study anti-HPV T cell response at M7 and M18 - To describe frequency and distributions of HPV genotypes in the genital tractus - To evaluate the occurrence of clinical lesions (genital warts, cervical lesions) - To describe the frequency of adverse events ;Primary end point(s): Seroconversion rate for HPV 16 and 18 at M18;Timepoint(s) of evaluation of this end point: 18 month after first injection | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Geometric means of anti-HPV 16 and 18 antibody titers at M7, M18, and M36, respectively. Proportion of patients with a good cell response at M7 and M18 Number, type and time of occurrence of HPV genotypes 6, 11, 16, 18 in the genital tractus Proportion of patients with genital warts or cervical lesions (if relevant) Number, type and time of occurrence of adverse events of any grade between D0 and M36 | — |
Countries
France
Outcome results
None listed