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TransplantationPhase 2PRIMAVERANCT01687192

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

A Phase 2 study testing HPV prophylactic vaccine Gardasil in people with Transplantation and Systemic Lupus Erythematosus, run by University Hospital, Bordeaux at 9 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 9 to 18 years, women only
What is being tested?
HPV prophylactic vaccine Gardasil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
9 sitesFrance
Study dates
11 Oct 2012to 20 Oct 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 18 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Active opportunistic infection
  • HIV infection
  • Concurrent clinical trial

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

France9 sites

  • CHU de Bordeaux, Hôpital Pellegrin-Enfants

    Bordeaux, 33076

  • HCLyon, Hôpital Femme-mère-enfant

    Bron, 69677

  • CHU de Lille, Hôpital Jeanne de Flandres

    Lille, 59037

  • CHU de Montpellier, Hôpital Arnaud de Villeneuve

    Montpellier, 34295

  • CHU de Nantes, Hôpital Mère-Enfants

    Nantes, 44093

  • AP-HP, Hôpital Robert Debré

    Paris, 75019

  • AP-HP, Hôpital Armand Trousseau

    Paris, 75571

  • AP-HP, Hôpital Necker-Enfants

    Paris, 75743

  • CHU de Toulouse, Hôpital des Enfants

    Toulouse, 31059

Other trials in France

About this study

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.

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.

Read the 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.

Being tested
HPV prophylactic vaccine Gardasil
Keywords
Seroconversion, Immunosuppressed treatment, HPV vaccination, Immunogenicity
Medical subject headings
Lupus Erythematosus, Systemic, HIV Seropositivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HPV prophylactic vaccine GardasilBiological

    3 injections: at Inclusion visit then 2 and 6 months after.

Study groups in NCT01687192
Study groupRoleWhat they receive
Girls and young womens receiving immunosuppressive treatmentExperimentalNot described
Receives: Biological: HPV prophylactic vaccine Gardasil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Seroconversion rate for HPV 16 and 18 at M18

    Measured: 18 months after first dose of vacinne (i.e. Inclusion visit)

Secondary outcomes (4)

  1. Geometric means of anti-HPV 6, 11, 16 and 18 antibody titers at M7, M18, and M36, respectively.

    Measured: 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

    Measured: 7 and 18 months after first dose of vaccine

  3. Proportion of patients with genital warts or cervical lesions (if relevant)

    Measured: 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

    Measured: Assessed at months 2,6,7 and 18 after first dose of vaccine

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2012 (estimated)
  2. Study start11 Oct 2012
  3. Primary completionMay 2015
  4. Study completion20 Oct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01687192
Sponsor's protocol ID
CHUBX 2011/18
Other IDs
2011-006002-27
Acronym
PRIMAVERA
Status last verified
Jul 2024
First submitted
13 Sep 2012
Last updated
20 May 2026
Results posted
No
Data monitoring committee
No

Publications

  • Koutsky L. The epidemiology behind the HPV vaccine discovery. Ann Epidemiol. 2009 Apr;19(4):239-44. doi: 10.1016/j.annepidem.2009.01.023.

    PubMed 19344861

  • Johnson AM, Mercer CH, Erens B, Copas AJ, McManus S, Wellings K, Fenton KA, Korovessis C, Macdowall W, Nanchahal K, Purdon S, Field J. Sexual behaviour in Britain: partnerships, practices, and HIV risk behaviours. Lancet. 2001 Dec 1;358(9296):1835-42. doi: 10.1016/S0140-6736(01)06883-0.

    PubMed 11741621

  • Winer RL, Lee SK, Hughes JP, Adam DE, Kiviat NB, Koutsky LA. Genital human papillomavirus infection: incidence and risk factors in a cohort of female university students. Am J Epidemiol. 2003 Feb 1;157(3):218-26. doi: 10.1093/aje/kwf180.

    PubMed 12543621

  • Collins S, Mazloomzadeh S, Winter H, Blomfield P, Bailey A, Young LS, Woodman CB. High incidence of cervical human papillomavirus infection in women during their first sexual relationship. BJOG. 2002 Jan;109(1):96-8. doi: 10.1111/j.1471-0528.2002.01053.x.

    PubMed 11845815

  • Myers ER, McCrory DC, Nanda K, Bastian L, Matchar DB. Mathematical model for the natural history of human papillomavirus infection and cervical carcinogenesis. Am J Epidemiol. 2000 Jun 15;151(12):1158-71. doi: 10.1093/oxfordjournals.aje.a010166.

    PubMed 10905528

  • Penn I. Occurrence of cancers in immunosuppressed organ transplant recipients. Clin Transpl. 1998:147-58.

    PubMed 10503093

  • Fairley CK, Chen S, Tabrizi SN, McNeil J, Becker G, Walker R, Atkins RC, Thomson N, Allan P, Woodburn C, et al. Prevalence of HPV DNA in cervical specimens in women with renal transplants: a comparison with dialysis-dependent patients and patients with renal impairment. Nephrol Dial Transplant. 1994;9(4):416-20.

    PubMed 8084456

  • ter Haar-van Eck SA, Rischen-Vos J, Chadha-Ajwani S, Huikeshoven FJ. The incidence of cervical intraepithelial neoplasia among women with renal transplant in relation to cyclosporine. Br J Obstet Gynaecol. 1995 Jan;102(1):58-61. doi: 10.1111/j.1471-0528.1995.tb09027.x.

    PubMed 7833312

  • Fairley CK, Sheil AG, McNeil JJ, Ugoni AM, Disney AP, Giles GG, Amiss N. The risk of ano-genital malignancies in dialysis and transplant patients. Clin Nephrol. 1994 Feb;41(2):101-5.

    PubMed 8004825

  • Kessler M, Jay N, Molle R, Guillemin F. Excess risk of cancer in renal transplant patients. Transpl Int. 2006 Nov;19(11):908-14. doi: 10.1111/j.1432-2277.2006.00383.x.

    PubMed 17018126

  • Birkeland SA, Lokkegaard H, Storm HH. Cancer risk in patients on dialysis and after renal transplantation. Lancet. 2000 May 27;355(9218):1886-7. doi: 10.1016/s0140-6736(00)02298-4.

    PubMed 10866449

  • Vajdic CM, McDonald SP, McCredie MR, van Leeuwen MT, Stewart JH, Law M, Chapman JR, Webster AC, Kaldor JM, Grulich AE. Cancer incidence before and after kidney transplantation. JAMA. 2006 Dec 20;296(23):2823-31. doi: 10.1001/jama.296.23.2823.

    PubMed 17179459

  • Nyberg G, Eriksson O, Westberg NG. Increased incidence of cervical atypia in women with systemic lupus erythematosus treated with chemotherapy. Arthritis Rheum. 1981 May;24(5):648-50. doi: 10.1002/art.1780240503.

    PubMed 7236321

  • Nath R, Mant C, Luxton J, Hughes G, Raju KS, Shepherd P, Cason J. High risk of human papillomavirus type 16 infections and of development of cervical squamous intraepithelial lesions in systemic lupus erythematosus patients. Arthritis Rheum. 2007 May 15;57(4):619-25. doi: 10.1002/art.22667.

    PubMed 17471531

  • Tam LS, Chan PK, Ho SC, Yu MM, Yim SF, Cheung TH, Wong MC, Li EK. Natural history of cervical papilloma virus infection in systemic lupus erythematosus - a prospective cohort study. J Rheumatol. 2010 Feb;37(2):330-40. doi: 10.3899/jrheum.090644. Epub 2009 Dec 23.

    PubMed 20032093

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HPV prophylactic vaccine Gardasil in people with Transplantation and Systemic Lupus Erythematosus, run by University Hospital, Bordeaux at 9 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01687192, which also lists 34 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.

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