Administration of 9valent vaccine against papillomavirus in HIV-positive wome
- Conditions
- Immune responses to administration of 9valent vaccine against HPV in HIV-positive womenMedDRA version: 20.0 Level: LLT Classification code 10020180 Term: HIV positive System Organ Class: 100000004848Therapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2018-000228-33-BE
- Lead Sponsor
- CHU Saint-Pierre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- Not specified
- Target Recruitment
- 200
•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 the screening CV 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
Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•Previous hysterectomy or conisation
•Previous or current biopsy-proven cervical, vulvar or vaginal HPV-associated high grade lesions 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method