Multicenter Trial Evaluating the Immunogenicity of HPV Vaccination in Girls on Immunosuppressive Therapy. (PRIMAVERA)
|Transplantation Systemic Lupus Erythematosus Systemic Immune Disease||Biological: HPV prophylactic vaccine Gardasil||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
|Official 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.|
- Seroconversion rate for HPV 16 and 18 at M18 [ Time Frame: 18 months after first dose of vacinne (i.e. Inclusion visit) ]
- Geometric means of anti-HPV 6, 11, 16 and 18 antibody titers at M7, M18, and M36, respectively. [ Time Frame: Samples collected 7, 18 and 36 months after first dose of vaccine ]
- Proportion of patients with a good cell response at M7 and M18 [ Time Frame: 7 and 18 months after first dose of vaccine ]
- Proportion of patients with genital warts or cervical lesions (if relevant) [ Time Frame: 36 months after first dose of vaccine ]
- Number, type and time of occurrence of adverse events of any grade during 18 months after first dose of vaccine [ Time Frame: Assessed at months 2,6,7 and 18 after first dose of vaccine ]
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||November 2016|
|Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
|Experimental: Girls and young womens receiving immunosuppressive treatment||
Biological: HPV prophylactic vaccine Gardasil
3 injections: at Inclusion visit then 2 and 6 months after.
The human papillomaviruses (HPV) are the cause of the most common sexually transmitted infection. Among oncogenic HPV, HPV 16 and 18 are found in 70% of invasive cancers. Among the non-oncogenic HPV, HPV 6 and 11 are found in 90% of anogenital warts. Two prophylactic vaccines are currently available: Gardasil ® protects against HPV 6, 11, 16 and 18 and Cervarix ® that protects against HPV16 and 18. Gardasil ® is indicated for the prevention of high-grade cervical dysplasia (CIN2-3), cancers of the cervix, high-grade dysplasia of the vulva (VIN2-3) and genital warts.
The choice of Gardasil ® is linked to the theoretical risk of graft rejection with the bivalent vaccine, and the fact that the frequency of anogenital warts related to HPV 6 and 11 is increased in the immunocompromised population.
The immunosuppressed women are more likely to present abnormal cervical smears than general population.
A notice on the age of vaccination against HPV for girls to receive a transplant was made by the High Council of Public Health, recommending that vaccination against HPV could be offered to girls to benefit a transplant before the age of 14 years and according to data from the MA. The High Council of Public Health also renewed its request that studies be conducted specifically on the vaccination of girls and young women, immunocompromised, including those receiving immunosuppressive therapy.
The primary objective is to evaluate the persistence of immunological response to tetravalent HPV vaccine at 18 months after first dose of vaccine.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01687192
|CHU de Bordeaux, Hôpital Pellegrin-Enfants|
|Bordeaux, France, 33076|
|HCLyon, Hôpital Femme-mère-enfant|
|Bron, France, 69677|
|CHU de Lille, Hôpital Jeanne de Flandres|
|Lille, France, 59037|
|CHU de Montpellier, Hôpital Arnaud de Villeneuve|
|Montpellier, France, 34295|
|CHU de Nantes, Hôpital Mère-Enfants|
|Nantes, France, 44093|
|AP-HP, Hôpital Robert Debré|
|Paris, France, 75019|
|AP-HP, Hôpital Armand Trousseau|
|Paris, France, 75571|
|AP-HP, Hôpital Necker-Enfants|
|Paris, France, 75743|
|CHU de Toulouse, Hôpital des Enfants|
|Toulouse, France, 31059|
|Study Chair:||Geneviève CHENE, MD-PhD||University Hospital, Bordeaux, USMR|
|Principal Investigator:||Jerome HARAMBAT, MD||University Hospital, Bordeaux|