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

September 13, 2012
July 1, 2014
October 2012
May 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01687192 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Multicenter Trial Evaluating the Immunogenicity of HPV Vaccination in Girls on Immunosuppressive Therapy.
Multicenter Clinical Trial Evaluating the Immunological Response of Vaccination Against Infection by Human Papillomavirus (HPV) 6, 11, 16, 18 in Girls Receiving Immunosuppressive Therapy.

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
  • Transplantation
  • Systemic Lupus Erythematosus
  • Systemic Immune Disease
Biological: HPV prophylactic vaccine Gardasil
3 injections: at Inclusion visit then 2 and 6 months after.
Experimental: Girls and young womens receiving immunosuppressive treatment
Intervention: Biological: HPV prophylactic vaccine Gardasil

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
37
November 2016
May 2015   (final data collection date for primary outcome measure)

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
Female
9 Years to 18 Years
No
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
France
 
NCT01687192
CHUBX 2011/18
No
University Hospital, Bordeaux
University Hospital, Bordeaux
Not Provided
Study Chair: Geneviève CHENE, MD-PhD University Hospital, Bordeaux, USMR
Principal Investigator: Jerome HARAMBAT, MD University Hospital, Bordeaux
University Hospital, Bordeaux
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP