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Multicenter Trial Evaluating the Immunogenicity of HPV Vaccination in Girls on Immunosuppressive Therapy.

CompletedPhase 2

Sponsor: University Hospital, Bordeaux

Conditions: Transplantation, Systemic Lupus Erythematosus, Systemic Immune Disease

Interventions: HPV prophylactic vaccine Gardasil

Countries: France

PRIMAVERA is a Phase IIa clinical trial, with the objective to assess the immunologic response to HPV vaccine in a population of immunocompromised girls. The principal hypothesis is that the immunologic response to tetravalent vaccine in girls who received immunosuppressive treatment is comparable to the immunologic response in girls that are not immunosuppressed.

Eligibility overview

Sex: FEMALE

Age: 9 Years to 18 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Female gender
* Age ≥ 9 years and \< 18 years
* Weight ≥ 25 kg
* 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 or diagnosis of systemic immune disease 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

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

Locations (9)

Bordeaux, France
Bron, France
Lille, France
Montpellier, France
Nantes, France
Paris, France
Paris, France
Paris, France
Toulouse, France