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

University Hospital of Bordeaux

Status and phase

Completed

Phase 2

Conditions

Transplantation

Systemic Lupus Erythematosus

Systemic Immune Disease

Treatments

Biological: HPV prophylactic vaccine Gardasil

Study type

Interventional

Funder types

Other

Identifiers

NCT01687192

CHUBX 2011/18

Details and patient eligibility

About

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.

Full 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.

Enrollment

37 estimated patients

Sex

Female

Ages

9 to 18 years old

Volunteers

No Healthy Volunteers

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