Multicentre trial evaluating the immunogenicity of HPV vaccination in girls on immunosuppressive therapy. - PRIMAVERA

• Conditions: Infection by HPV 6, 11, 16, 18; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-006002-27-FR
• Lead Sponsor: CHU de Bordeaux

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-05
• Last Update Posted: 14 April 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

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

- Male gender
- Pregnancy
- Age < 9 years or > 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>- To study anti-HPV T cell response at M7 and M18<br>- To describe frequency and distributions of HPV genotypes in the genital tractus<br>- To evaluate the occurrence of clinical lesions (genital warts, cervical lesions)<br>- To describe the frequency of adverse events <br>;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 Outcome Measures

Name	Time	Method
Secondary end point(s): Geometric means of anti-HPV 16 and 18 antibody titers at M7, M18, and M36, respectively.<br>Proportion of patients with a good cell response at M7 and M18<br>Number, type and time of occurrence of HPV genotypes 6, 11, 16, 18 in the genital tractus <br>Proportion of patients with genital warts or cervical lesions (if relevant) <br>Number, type and time of occurrence of adverse events of any grade between D0 and M36<br>