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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University Hospital, Bordeaux
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01687192
First received: September 13, 2012
Last updated: July 1, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Transplantation
Systemic Lupus Erythematosus
Systemic Immune Disease
Biological: HPV prophylactic vaccine Gardasil
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Seroconversion rate for HPV 16 and 18 at M18 [ Time Frame: 18 months after first dose of vacinne (i.e. Inclusion visit) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Proportion of patients with a good cell response at M7 and M18 [ Time Frame: 7 and 18 months after first dose of vaccine ] [ Designated as safety issue: No ]
  • Proportion of patients with genital warts or cervical lesions (if relevant) [ Time Frame: 36 months after first dose of vaccine ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 37
Study Start Date: October 2012
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Girls and young womens receiving immunosuppressive treatment Biological: HPV prophylactic vaccine Gardasil
3 injections: at Inclusion visit then 2 and 6 months after.

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.

  Eligibility

Ages Eligible for Study:   9 Years to 18 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01687192

Contacts
Contact: Jerome HARAMBAT, MD (0)556798725 ext +33 jerome.harambat@chu-bordeaux.fr
Contact: Guillaume SIMON, CRA (0)5 57 82 00 03 ext +33 guillaume.simon@chu-bordeaux.fr

Locations
France
CHU de Bordeaux, Hôpital Pellegrin-Enfants Recruiting
Bordeaux, France, 33076
Contact: Guillaume SIMON, CRA    (0)5 57 82 00 03 ext +33    guillaume.simon@chu-bordeaux.fr   
Principal Investigator: Jerome HARAMBAT, MD         
Sub-Investigator: Brigitte LLANAS, MD         
Sub-Investigator: Thierry LAMIREAU, MD         
HCLyon, Hôpital Femme-mère-enfant Recruiting
Bron, France, 69677
Contact: Pierre COCHAT, MD    (0)4 72 11 03 46 ext +33    pierre.cochat@chu-lyon.fr   
Principal Investigator: Pierre COCHAT, MD         
Sub-Investigator: Bruno RANCHIN, MD         
Sub-Investigator: Christine RIVET, MD         
Sub-Investigator: Alexandre BELOT, MD         
CHU de Lille, Hôpital Jeanne de Flandres Recruiting
Lille, France, 59037
Contact: Annie LAHOCHE, MD    (0)3 20 44 46 95 ext +33    annie.lahoche@chru-lille.fr   
Principal Investigator: Annie LAHOCHE, MD         
Sub-Investigator: Maud DEHENNAULT, MD         
Sub-Investigator: Frédéric GOTTRAND, MD         
Sub-Investigator: Valérie LEROY, MD         
CHU de Limoges, Hôpital Mère Enfant Not yet recruiting
Limoges, France, 87042
Contact: Vincent GUIGONIS, MD    (0)5 55 05 63 58 ext +33    vincent.guigonis@chu-limoges.fr   
Principal Investigator: Vincent GUIGONIS, MD         
AP-HM Hôpital Timone-Enfants Not yet recruiting
Marseille, France, 13385
Contact: Florentine GARAIX, MD    (0)4 91 38 67 42 ext +33    florentine.garaix@ap-hm.fr   
Principal Investigator: Florentine GARAIX, MD         
Sub-Investigator: Michel TSIMARATOS, MD         
Sub-Investigator: Bernard KREITMANN, MD         
CHU de Montpellier, Hôpital Arnaud de Villeneuve Recruiting
Montpellier, France, 34295
Contact: Denis MORIN, MD    (0)4 67 33 66 07 ext +33    d-morin@chu-montpellier.fr   
Principal Investigator: Denis MORIN, MD         
CHU de Nantes, Hôpital Mère-Enfants Recruiting
Nantes, France, 44093
Contact: Gwenaëlle ROUSSEY, MD    (0)2 40 08 34 80 ext +33    gwenaelle.roussey@chu-nantes.fr   
Principal Investigator: Gwenaëlle ROUSSEY-KESLER, MD         
Sub-Investigator: Emma ALLAIN-LAUNAY, MD         
AP-HP, Hôpital Armand Trousseau Recruiting
Paris, France, 75571
Contact: Tim ULINSKI, MD    (0)1 44 73 66 62 ext +33    tim.ulinski@trs.aphp.fr   
Principal Investigator: Tim ULINSKI, MD         
AP-HP, Hôpital de La Pitié-Salpêtrière Recruiting
Paris, France, 75013
Contact: Zahir AMOURA, MD    (0)1 42 17 80 01 ext +33    zahir.amoura@psl.aphp.fr   
Principal Investigator: Zahir AMOURA, MD         
AP-HP, Hôpital Necker-Enfants Recruiting
Paris, France, 75743
Contact: Dominique DEBRAY, MD    (0)1 44 49 25 60 ext +33    dominique.debray@nck.aphp.fr   
Principal Investigator: Dominique DEBRAY, MD         
Sub-Investigator: Rémi SALOMON, MD         
Sub-Investigator: Genevieve GUEST, MD         
Sub-Investigator: Marina CHARBIT, MD         
Sub-Investigator: Brigitte BADER-MEUNIER, MD         
AP-HP, Hôpital Robert Debré Recruiting
Paris, France, 75019
Contact: Marie-Alice MACHER, MD    (0)1 40 03 23 98 ext +33    marie-alice.macher@rdb.aphp.fr   
Principal Investigator: Marie-Alice MACHER, MD         
Sub-Investigator: Georges DESCHENES, MD         
Sub-Investigator: Véronique BAUDOUIN, MD         
Sub-Investigator: Anne MAISIN, MD         
CHU de Strasbourg, Hôpital de Hautepierre Not yet recruiting
Strasbourg, France, 67098
Contact: Michel FISCHBACH, MD    (0)3 88 12 77 43 ext +33    michel.fischbach@chru-strasbourg.fr   
Principal Investigator: Michel FISCHBACH, MD         
CHU de Toulouse, Hôpital des Enfants Recruiting
Toulouse, France, 31059
Contact: Stéphane DECRAMER, MD    (0)5 34 55 86 64 ext +33    decramer.s@chu-toulouse.fr   
Principal Investigator: Stéphane DECRAMER, MD         
Sub-Investigator: Arnaud GARNIER, MD         
Sub-Investigator: Pierre BROUE, MD         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Study Chair: Geneviève CHENE, MD-PhD University Hospital, Bordeaux, USMR
Principal Investigator: Jerome HARAMBAT, MD University Hospital, Bordeaux
  More Information

Publications:

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01687192     History of Changes
Other Study ID Numbers: CHUBX 2011/18
Study First Received: September 13, 2012
Last Updated: July 1, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Bordeaux:
Seroconversion
Immunosuppressed treatment
HPV vaccination
Immunogenicity

Additional relevant MeSH terms:
Immune System Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014