Status:
ACTIVE_NOT_RECRUITING
Vaccination Against Human Papillomavirus (HPV) With the 9-valent Vaccine in HIV-positive Women (the Papillon Study)
Lead Sponsor:
Centre Hospitalier Universitaire Saint Pierre
Conditions:
HPV - Anogenital Human Papilloma Virus Infection
HIV Infections
Eligibility:
FEMALE
15-40 years
Phase:
PHASE4
Brief Summary
Phase IV prospective study measuring the immunogenicity (neutralizing antibody titles against each HPV vaccine genotype) of the 9-valent vaccine against HPV (Gardasil9®Merck) in HIV-positive women age...
Detailed Description
Number of patients: Study: 200 patients: 50 in the first open label phase (june 2018 to dec 2018), then n=150 in the randomized phase starting in January 2019 Substudy on immune response analysis in ...
Eligibility Criteria
Inclusion
- HIV-positive woman
- Age 15-40 years
- Undetectable HIV viral load (HIVRNA \<400 cp/ml) for at least 6 months (i,e: having at least two separate HIVRNA \<400 cp/ml at 6 months intervals; the most recent HIVRNA \<400 cp/ml may be performed with the baseline sample for the study).
- No planned pregnancy foreseen for the next 7 months and use of contraception such as condom, hormonal contraception or intrauterine device
- IC signed
Exclusion
- Previous hysterectomy or conisation
- Previous or current biopsy-proven cervical, vulvar or vaginal HPV-associated lesion defined as ≥ cervical intraepithelial neoplasia grade 2(CIN2) ) , Vulvar intraepithelial neoplasia grade 2 (VIN2), vaginal intraepithelial neoplasia grade 2 (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.
Key Trial Info
Start Date :
January 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 2 2028
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT03391921
Start Date
January 8 2018
End Date
May 2 2028
Last Update
February 17 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Service de Maladies Infectieuses, CHU Saint-Pierre
Brussels, Belgium, 1000