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

May 19, 2026 updated by: University Hospital, Bordeaux

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

37

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • CHU de Bordeaux, Hôpital Pellegrin-Enfants
      • Bron, France, 69677
        • HCLyon, Hôpital Femme-mère-enfant
      • Lille, France, 59037
        • CHU de Lille, Hôpital Jeanne de Flandres
      • Montpellier, France, 34295
        • CHU de Montpellier, Hôpital Arnaud de Villeneuve
      • Nantes, France, 44093
        • CHU de Nantes, Hôpital Mère-Enfants
      • Paris, France, 75019
        • AP-HP, Hôpital Robert Debré
      • Paris, France, 75571
        • AP-HP, Hôpital Armand Trousseau
      • Paris, France, 75743
        • AP-HP, Hôpital Necker-Enfants
      • Toulouse, France, 31059
        • CHU de Toulouse, Hôpital des Enfants

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Samples collected 7, 18 and 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
7 and 18 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
36 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
Assessed at months 2,6,7 and 18 after first dose of vaccine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2012

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

October 20, 2016

Study Registration Dates

First Submitted

September 13, 2012

First Submitted That Met QC Criteria

September 13, 2012

First Posted (Estimated)

September 18, 2012

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2011/18
  • 2011-006002-27 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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