A Phase 2 interventional study of HPV prophylactic vaccine Gardasil in Transplantation, Systemic Lupus Erythematosus and Systemic Immune Disease, sponsored by University Hospital, Bordeaux. Completed at 9 sites in France. Open to female participants aged 9 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-05-20.
Sponsored by University Hospital, Bordeaux · Phase 2, Interventional, and Other
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.
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.
1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.
This study's planned enrollment of 37 is below the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Biological: HPV prophylactic vaccine Gardasil
3 injections: at Inclusion visit then 2 and 6 months after.
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
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Lupus Erythematosus, Systemic→
University Hospital, Bordeaux