Long Term Immunogenicity of Quadrivalent Human Papillomavirus Vaccine (Gardasil®)in HIV-infected Adolescents and Young Adults vs. Healthy Adolescents and Young Adults: Non-randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- University of Milan
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- type specific antibody titers for HPV types 6, 11, 16 and 18 at one month after completion of HPV vaccine series (T3) in HIV infected subjects vs. healthy subjects
Study Overview
Brief Summary
Infection with human immunodeficiency virus (HIV) is an important risk factor for HPV infection and the development of HPV-associated lesions in female and male anogenital tract. Data on safety and immunogenicity of quadrivalent human papillomavirus vaccine in HIV-infected population are few. The present study is a non-randomized controlled clinical trial with the primary objective to determine safety ad immunogenicity of quadrivalent human papillomavirus vaccine (Gardasil®) in HIV-infected female and male adolescents and young adults.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 13 Years to 27 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •For both HIV-infected and healthy subjects:
- •Subjects aged 13-27 years, females and males
- •Written informed consent from parent or guardian if applicable (age<18 years)
- •For HIV-infected subjects:
- •HIV-positive
- •Asymptomatic subjects (generalized lymphadenopathy is accepted)
- •Lymphocyte CD4+ count > or equal to 350 cells/mm3
- •For subjects receiving HAART:
- •Good compliance to therapy
- •At least two suppressed viral loads HIV-RNA (<37copies/ml9 during 6 months prior to enrollment.
Exclusion Criteria
- •For female subjects (both HIV-infected and healthy)
- •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 hypersensitivity 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
- •Concomitant therapies (other than HAART):
- •Chronic therapy (for more than 14 days consecutively) with immunosuppressive or immunomodulating agents or chemotherapy during the 6 months prior to study entry.
- •Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation prior to study entry.
- •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.
Arms & Interventions
HIV-infected adolescents and young adults
female and male HIV-infected subjects aged from 13-27 years old
Intervention: Quadrivalent Human Papillomavirus (6, 11, 16 and 18) vaccine (Gardasil ®) (Biological)
healthy adolescents and young adults
female and male healthy adolescents and young adults aged 13-27 years
Intervention: Quadrivalent Human Papillomavirus (6, 11, 16 and 18) vaccine (Gardasil ®) (Biological)
Outcomes
Primary Outcomes
type specific antibody titers for HPV types 6, 11, 16 and 18 at one month after completion of HPV vaccine series (T3) in HIV infected subjects vs. healthy subjects
Time Frame: one month +/- 10 days after 3° vaccine dose
Immunogenicity of quadrivalent human papillomavirus vaccine (Gardasil®) will be assessed 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 one month after the completion of HPV vaccine series (T3), compared with the same immunogenicity testings performed in healthy subjects matched for sex and age.
Secondary Outcomes
- HIV viral load and lymphocyte CD4+ count(baseline (T0), one month after each vaccination dose (T1, T2 and T3) and at month 12 (T4) and 18 (T5) from baseline.)
- antibody HPV titers to types 6, 11, 16 and 18, one month after the first two vaccination series (T1 and T2) in HIV-infected subjects vs healthy subjects(one month +/- 10 days after 1°vaccine dose and month+/- 10 days after 2° vaccine dose)
- antibody titers to HPV types 6, 11, 16 and 18 at month 12(T4)and 18 (T5)from baseline (T0).(12 months +/- 10 days and 18 months +/-10 days from baseline)
- local and systemic adverse events(7 days after each vaccination dose)
- lymphoproliferative responses, cytokine production and immunophenotype analysis of lymphocyte subpopulations(baseline (T0), one month after 1° vaccination dose (T1) and one month after 3° vaccination dose (T3).)
Investigators
Gian Vincenzo Zuccotti
Long term Immunogenicity of Quadrivalent Human Papillomavirus vaccine (Gardasil®) in HIV-infected adolescents and young adults vs. healthy adolescents and young adults: non-randomized controlled clinical trial
University of Milan