Systemic Lupus Erythematosus Clinical Trial
— PRIMAVERAOfficial title:
Multicenter Clinical Trial Evaluating the Immunological Response of Vaccination Against Infection by Human Papillomavirus (HPV) 6, 11, 16, 18 in Girls Receiving Immunosuppressive Therapy.
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.
Status | Active, not recruiting |
Enrollment | 37 |
Est. completion date | November 2016 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 9 Years to 18 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
France | CHU de Bordeaux, Hôpital Pellegrin-Enfants | Bordeaux | |
France | HCLyon, Hôpital Femme-mère-enfant | Bron | |
France | CHU de Lille, Hôpital Jeanne de Flandres | Lille | |
France | CHU de Montpellier, Hôpital Arnaud de Villeneuve | Montpellier | |
France | CHU de Nantes, Hôpital Mère-Enfants | Nantes | |
France | AP-HP, Hôpital Armand Trousseau | Paris | |
France | AP-HP, Hôpital Necker-Enfants | Paris | |
France | AP-HP, Hôpital Robert Debré | Paris | |
France | CHU de Toulouse, Hôpital des Enfants | Toulouse |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bordeaux |
France,
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* Note: There are 34 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Seroconversion rate for HPV 16 and 18 at M18 | 18 months after first dose of vacinne (i.e. Inclusion visit) | No | |
Secondary | Geometric means of anti-HPV 6, 11, 16 and 18 antibody titers at M7, M18, and M36, respectively. | Samples collected 7, 18 and 36 months after first dose of vaccine | No | |
Secondary | Proportion of patients with a good cell response at M7 and M18 | 7 and 18 months after first dose of vaccine | No | |
Secondary | Proportion of patients with genital warts or cervical lesions (if relevant) | 36 months after first dose of vaccine | Yes | |
Secondary | Number, type and time of occurrence of adverse events of any grade during 18 months after first dose of vaccine | Assessed at months 2,6,7 and 18 after first dose of vaccine | Yes |
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