HUMAN PAPILLOMAVIRUS TYPE 31 L1 PROTEIN - ADSORBED - ... HUMAN PAPILLOMAVIRUS TYPE 6 L1 PROTEIN - ADSORBED (list of HPV L1 proteins for types 31,33,45,52,58,11,16,18,6 as given in product data) for HIV infection | Human papillomavirus infection

Inclusion criteria

• {"criterion_text":"- •\tHIV-positive woman"}
• {"criterion_text":"- •\tAge 15-40 years"}
• {"criterion_text":"- •\tUndetectable 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)."}
• {"criterion_text":"- •\tNo planned pregnancy foreseen for the next 7 first months and use of contraception such as condom, hormonal contraception or intrauterine device"}
• {"criterion_text":"- •\tIC signed"}

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Measured by neutralizing antibody against the 9 vaccine genotypes of HPV at baseline and month 7; comparison at month 7 with non-inferiority margin defined as at least 80% seroconversion in ARM A."}

Other endpoints

• {"endpoint_text":"- •\tCompletion of vaccine schedule.","definition_or_measurement_approach":"Completion of scheduled vaccine doses as per arm (2-dose or 3-dose schedule)."}
• {"endpoint_text":"- •\tSafety and clinical tolerance of the vaccine administration.","definition_or_measurement_approach":"Assessment of safety and tolerability during and after vaccination (clinically recorded adverse events and tolerability assessments)."}
• {"endpoint_text":"- •\tImpact on T-lymphocytes CD4+ counts and HIV viremia at month 7.","definition_or_measurement_approach":"Measurement of CD4+ T-lymphocyte counts and HIV viral load (viremia) at month 7."}
• {"endpoint_text":"- •\tRate 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.","definition_or_measurement_approach":"Measurement of neutralizing antibodies at baseline and months 18, 24, 36, 48, 60 to assess seroconversion rates over time."}
• {"endpoint_text":"- •\tMeasure of neutralizing antibodies title against each HPV vaccine types at baseline, month 7 and 18","definition_or_measurement_approach":"Quantitative titers of neutralizing antibodies against each HPV vaccine type at specified time points (baseline, month 7, month 18)."}
• {"endpoint_text":"- •\tAssessment of long term persistence of HPV-specific antibody responses at 24,36,48 and 60 months after completion of the last vaccine administration dose.","definition_or_measurement_approach":"Measurement of HPV-specific antibody levels at 24, 36, 48 and 60 months post-completion of vaccination to assess persistence."}
• {"endpoint_text":"- •\tThe 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.","definition_or_measurement_approach":"Cellular immune response assays on PBMC samples in a predefined subgroup (n=40); requires separate informed consent for this substudy."}
• {"endpoint_text":"- •\tIncidence 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.","definition_or_measurement_approach":"Cervical swab PCR for HPV and cytology assessments at baseline and 12 months after vaccination completion to determine incidence and prevalence of HPV infection and abnormal cytology."}

Belgium

Earliest CTIS Part Ii Submission Date

24-12-2024

Latest Decision Or Authorization Date

30-01-2025

Processing Time Days

37

Number Of Sites

1

Number Of Participants

169

Primary sponsor

Full Name

CHU Saint Pierre

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium

Third parties

• {"country":"Belgium","full_name":"CHU Saint Pierre","duties_or_roles":"[2,5,7,8]","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"","full_name":"King Bauduin Foundation","duties_or_roles":"Monetary support","organisation_type":""}