The papillon study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

CHU Saint Pierre

Participant type

Patients

Age range

18-64 years

Gender

Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Decision date (initial)

2025-01-30

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

King Bauduin Foundation

External identifiers

EU CT number

2024-520419-42-00

EudraCT number

2018-000228-33

ClinicalTrials.gov

NCT03391921

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

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).

Secondary objectives 1

1. • Completion of vaccine schedule. • Safety and clinical tolerance of the vaccine administration. • Impact on T-lymphocytes CD4+ counts and HIV viremia at month 7. • 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 Month 18, 24, 36, 48 and 60 compared to baseline. • Measure of neutralizing antibodies title against each HPV vaccine types at baseline, month 7 and 18 • Assessment of long term persistence of HPV-specific antibody responses at 24,36,48 and 60 months after completion of the last vaccine administration dose. • The cellular immune response against HPV 16/18/31/52/58 will be assessed in a subgroup of patients (n=40, 20 in each arm) on PBMC samples tested. For this analysis, a separated IC should be first signed by the patient. • Incidence and prevalence of HPV infections and of abnormal cervical cytology performed by cytology and PCR on cervical swab at baseline and 12 months after the end of vaccination.

Conditions and MedDRA coding

giving a commercially available vaccine to women with HIV under treatment

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. • 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

Exclusion criteria 1

1. • 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

CHU Saint Pierre

Sponsor organisation

CHU Saint Pierre

Address

Hoogstraat 322

City

Brussels

Postcode

1000

Country

Belgium

Scientific contact point

Organisation

CHU Saint Pierre

Contact name

Deborah KONOPNICKI

Public contact point

Organisation

CHU Saint Pierre

Contact name

Deborah KONOPNICKI

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications