Authorised Phase III and phase IV (Integrated) giving a commercially available vaccine to women with HIV under treatment

The papillon study

EU CTIS ID: 2024-520419-42-00

What this study is testing

Rate of seroconversion of neutralizing antibodies against each HPV vaccine genotypes namely 6/11/16/18/31/33/45/52/58 among women seronegative at baseline for HPV vaccine genotypes, by measuring neutralizing antibody against the 9 vaccine genotypes of HPV at baseline, month 7. Comparison of that rate at month 7 (non inferiority defined as at least 80% of seroconversion in ARM A).

  • Phase III and phase IV (Integrated)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • • HIV-positive woman • Age 15-40 years • Undetectable HIV viral load (VL) <400 cp/ml) for at least 6 months (i,e: having at least two separate VL<400 cp/ml at 6 months intervals; the most recent VL <400 cp/ml may be the screening CV for the study). • No planned pregnancy foreseen for the next 7 first months and use of contraception such as condom, hormonal contraception or intrauterine device • IC signed

You likely can't join if

  • • Previous hysterectomy or conisation • Previous or current biopsy-proven cervical, vulvar or vaginal HPV-associated lesion defined as ≥CIN2, VIN2, VaIN2 or invasive carcinoma • Previous vaccination against HPV (at least one dose) • Ongoing or planned pregnancy foreseen in the next 7 months • Other immunodeficiency conditions such as ongoing or previous (within 6 months) chemotherapy against cancer or chronic systemic corticosteroids treatment or immunosuppressive therapy after transplantation • Any condition contraindicating intramuscular injection such as warfarin therapy.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.