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

• Register: ClinicalTrials.gov
• Last refreshed on: 10 August 2015
• Main ID: NCT01687192
• Date of registration: 13/09/2012
• Prospective Registration: Yes
• Primary sponsor: University Hospital, Bordeaux
• Public title: Multicenter Trial Evaluating the Immunogenicity of HPV Vaccination in Girls on Immunosuppressive Therapy. PRIMAVERA
• Scientific 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.
• Date of first enrolment: October 2012
• Target sample size: 37
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT01687192
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label
• Phase: Phase 2

Countries of recruitment

France

Contacts

• Name: Geneviève CHENE, MD-PhD
• Affiliation: University Hospital, Bordeaux, USMR

• Name: Jerome HARAMBAT, MD
• Affiliation: University Hospital, Bordeaux

Key inclusion & exclusion criteria

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



Age minimum: 9 Years
Age maximum: 18 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Transplantation

Systemic Immune Disease

Systemic Lupus Erythematosus

Intervention(s)

Biological: HPV prophylactic vaccine Gardasil

Primary Outcome(s)

Seroconversion rate for HPV 16 and 18 at M18 [Time Frame: 18 months after first dose of vacinne (i.e. Inclusion visit)]

Secondary Outcome(s)

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 genital warts or cervical lesions (if relevant) [Time Frame: 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]

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]

Secondary ID(s)

CHUBX 2011/18

Source(s) of Monetary Support

Please refer to primary and secondary sponsors