Clinical trial NCT01512784: Long Term Immunogenicity of Quadrivalent Human Papillomavirus Vaccine (Gardasil®)in HIV-infected Adolescents and Young Adults
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: HPV
HIV
Keywords: Quadrivalent Human Papillomavirus Vaccine (HPV) Gardasil
HIV infection
Evaluation of quadrivalent HPV vaccine in adolescents and young adults.
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2012-01-19
Enrollment: 100
Sex: ALL
Minimum age (years): 13
Maximum age (years): 27
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: one month +/- 10 days after 3° vaccine dose
Secondary outcomes:
measure: 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
timeFrame: one month +/- 10 days after 1°vaccine dose and month+/- 10 days after 2° vaccine dose
measure: antibody titers to HPV types 6, 11, 16 and 18 at month 12(T4)and 18 (T5)from baseline (T0).
timeFrame: 12 months +/- 10 days and 18 months +/-10 days from baseline
measure: local and systemic adverse events
timeFrame: 7 days after each vaccination dose
measure: HIV viral load and lymphocyte CD4+ count
timeFrame: baseline (T0), one month after each vaccination dose (T1, T2 and T3) and at month 12 (T4) and 18 (T5) from baseline.
measure: lymphoproliferative responses, cytokine production and immunophenotype analysis of lymphocyte subpopulations
timeFrame: baseline (T0), one month after 1° vaccination dose (T1) and one month after 3° vaccination dose (T3).
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Luigi Sacco Hospital , Department of Paediatrics, via G.B Grassi, 74
Study officials:
affiliation: L.Sacco Hospital, via G.B Grassi, 74 20157 Milano, Italy
name: Gian Vincenzo Zuccotti, Head of Paediatric Department
role: PRINCIPAL_INVESTIGATOR
References: