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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01687192
Recruitment Status : Unknown
Verified July 2015 by University Hospital, Bordeaux.
Recruitment status was:  Active, not recruiting
First Posted : September 18, 2012
Last Update Posted : July 31, 2015
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Transplantation Systemic Lupus Erythematosus Systemic Immune Disease Biological: HPV prophylactic vaccine Gardasil Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : October 2012
Actual Primary Completion Date : May 2015
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Girls and young womens receiving immunosuppressive treatment Biological: HPV prophylactic vaccine Gardasil
3 injections: at Inclusion visit then 2 and 6 months after.

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

Secondary Outcome Measures :
  1. 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 ]
  2. Proportion of patients with a good cell response at M7 and M18 [ Time Frame: 7 and 18 months after first dose of vaccine ]
  3. Proportion of patients with genital warts or cervical lesions (if relevant) [ Time Frame: 36 months after first dose of vaccine ]
  4. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01687192

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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
Sponsors and Collaborators
University Hospital, Bordeaux
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Study Chair: Geneviève CHENE, MD-PhD University Hospital, Bordeaux, USMR
Principal Investigator: Jerome HARAMBAT, MD University Hospital, Bordeaux

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Responsible Party: University Hospital, Bordeaux Identifier: NCT01687192    
Other Study ID Numbers: CHUBX 2011/18
First Posted: September 18, 2012    Key Record Dates
Last Update Posted: July 31, 2015
Last Verified: July 2015
Keywords provided by University Hospital, Bordeaux:
Immunosuppressed treatment
HPV vaccination
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Immune System Diseases
Connective Tissue Diseases
Autoimmune Diseases