CompletedPhase 2

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

France37 participantsStarted 2012-10-11

Plain-language 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.

Who can participate

Age range

9 Years – 18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial focused on girls who are on immunosuppressive therapy — like those with lupus or after a transplant — so how does my daughter's specific medication affect whether the HPV vaccine would actually produce a strong enough immune response in her?
2Since this was a Phase 2 trial measuring seroconversion rates at 18 months, what do the results suggest about how well the HPV vaccine worked in girls with conditions like hers, and is that protection considered durable enough?
3The trial is now completed — does that mean the findings have been published, and if so, would you be able to walk me through what the data showed about safety in immunosuppressed girls specifically?
4Given that my daughter has a systemic immune disease and is on immunosuppression, would the standard HPV vaccination schedule still be recommended for her outside of a trial setting, or would her care need to be adjusted based on what this study found?
5Are there any ongoing or follow-up studies building on this trial's results that might be relevant for my daughter, or is the current evidence strong enough to guide her HPV vaccination decisions right now?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Seroconversion rate for HPV 16 and 18 at M18

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

Trial details

NCT IDNCT01687192

SponsorUniversity Hospital, Bordeaux

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-05

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