HIV+ teenagers and young adults versus HIV-negative subjects: high-risk population for HPV-related disease. MedDRA version: 14.1 Level: LLT Classification code 10063001 Term: Human papilloma virus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: GARDASIL*SIR IM 0,5ML C/DISP+
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: HPV 6 TYPE L1 PROTEIN ADS. ON AMORPHOUS ALUMINIUM HYDROXYPHOSPHATE SULPHATE [PROD. IN S. CE
Sponsors
AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For both HIV-infected and healthy subjects: • Subjects aged 13-27 years • Females or males • Written informed consent from parent or guardian if applicable (age 350 cell/mm3 • For subjects receiving HAART: - Goog compliance to therapy - At least two suppressed viral loads HIV-RNA (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: For female subjects (both HIV-infected and healthy) : • Current (within 6 months prior to study entry) abnormal Pap test with confirmed biopsy results of cervical intraepithelial neoplasia CIN 2/3 caused by genotype HPV 16, 18 or cervical cancer within 180 days prior to study entry. • Pregnancy or breastfeeding • Total hysterectomy. Participants who have undergone partial hysterectomy and have a cervix are not excluded For both females and males (HIV-infected and healthy): • Prior vaccination with quadrivalent HPV vaccine (Gardasil) before study entry. • History of severe allergic reaction after previous vaccination or hypersensytivity to any vaccine component • Any serious chronic or progressive disease (other than HIV) according to the judgment of the investigator: - Acute infection requiring therapy or fever at time of enrollment - Chronic autoimmune or oncologic disease receiving chemotherapy - Tuberculosis - Neurologic disease or history of convulsions • Concomitant therapies (other than HAART): - Chronic therapy ( for more than 14 days consecutively) with immunosoppressive or immunomodulating agents or chemotherapy during the 6 months prior to study entry. - Ongoing anti-tubercular therapy - Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation prior to study entry • Severe anemia: hemoglobin less than 8.0 g/dL. • Acute or chronic impairment of pulmonary, cardiac, hepatic o renal function. • Use of investigational agents within 4 weeks prior to study enrollment. • Current drug or alcohol use or dependence • Documented history of non-adherence to antiretroviral treatment regimen within 12 months prior to study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To assess the immunogenicity of quadrivalent human papillomavirus vaccine (Gardasil) in male and female HIV-infected adolescents and young adults, by evaluation of type-specific antibody development for HPV types 6, 11, 16 and 18 from seronegative status at baseline (T0) to seropositive status at a month after the completion of HPV vaccine series (T3), compared with the same immunogenicity testings performed in healthy subjects of the same age.;Secondary Objective: Evaluate HPV antibody titers to types 6, 11, 16, 18, one month after each vaccination dose (T1, T2, T3) in HIV-infected adolescents and young adults compared with the same immunological testings in healthy adolscents and young adults. To assess long-term immunogenicity of quadrivalent human papillomavirus vaccine (Gardasil) in HIV-infected and healthy subjects by evaluation of persistence of HPV antibody titers to types 6, 11, 16 and 18 at month 12 (T4) and 18 (T5) from baseline (T0). To assess the safety and tolerability of three doses of quadrivalent human papillomavirus vaccine (Gardasil) in HIV-infected and healthy subjects by evaluating the occurrence and severity of local and systemic adverse events during the 7 days after each vaccination dose. Longitudinal monitoring of HIV-viral load and CD4 count in HIV-infected subjects from baseline (T0), throughout the study.;Primary end point(s): Type-specific antibody development for HPV types 6, 11, 16 and 18 from seronegative status at baseline to seropositive status at a month after the completion of HPV vaccine series.;Timepoint(s) of evaluation of this end point: One month after the completion of HPV vaccine series. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Antibody kinetics and persistance.;Timepoint(s) of evaluation of this end point: At 1 month after each dose and 12 and 18 months from the first dose. | — |
Countries
Italy
Contacts
Public ContactDivisione Clinicizzata di Pediatria
Ospedale Luigi Sacco
Outcome results
None listed