This trial is active, not recruiting.

Conditions transplantation, systemic lupus erythematosus, systemic immune disease
Treatment hpv prophylactic vaccine gardasil
Phase phase 2
Sponsor University Hospital, Bordeaux
Start date October 2012
End date May 2015
Trial size 37 participants
Trial identifier NCT01687192, CHUBX 2011/18


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
hpv prophylactic vaccine gardasil
3 injections: at Inclusion visit then 2 and 6 months after.

Primary Outcomes

Seroconversion rate for HPV 16 and 18 at M18
time frame: 18 months after first dose of vacinne (i.e. Inclusion visit)

Secondary Outcomes

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

Eligibility Criteria

Female participants from 9 years up to 18 years old.

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

Additional Information

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.
Principal investigator Jerome HARAMBAT, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by University Hospital, Bordeaux.