Long Term Immunogenicity of Quadrivalent Human Papillomavirus Vaccine (Gardasil®)in HIV-infected Adolescents and Young Adults

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by University of Milan.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Gian Vincenzo Zuccotti, University of Milan
ClinicalTrials.gov Identifier:
NCT01512784
First received: January 13, 2012
Last updated: January 18, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
HPV
HIV
Biological: Quadrivalent Human Papillomavirus (6, 11, 16 and 18) vaccine (Gardasil ®)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by University of Milan:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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 [ Time Frame: one month +/- 10 days after 1°vaccine dose and month+/- 10 days after 2° vaccine dose ] [ Designated as safety issue: No ]
    Antibody titers for HPV types 6, 11, 16 and 18 will be evaluated one month after the first (T1) and second (T2) vaccination dose in HIV-infected adolescents and young adults compared with the same immunological testings in healthy adolescents and young adults.

  • antibody titers to HPV types 6, 11, 16 and 18 at month 12(T4)and 18 (T5)from baseline (T0). [ Time Frame: 12 months +/- 10 days and 18 months +/-10 days from baseline ] [ Designated as safety issue: No ]
    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).

  • local and systemic adverse events [ Time Frame: 7 days after each vaccination dose ] [ Designated as safety issue: Yes ]
    Safety and tolerability of three doses of quadrivalent human papillomavirus vaccine (Gardasil ®) in HIV-infected and healthy subjects will be assessed by evaluating the occurrence and severity of local and systemic adverse events during the 7 days after each vaccination dose.

  • HIV viral load and lymphocyte CD4+ count [ Time Frame: baseline (T0), one month after each vaccination dose (T1, T2 and T3) and at month 12 (T4) and 18 (T5) from baseline. ] [ Designated as safety issue: No ]
    Longitudinal monitoring of HIV-viral load and lymphocyte CD4+ count will be conducted in HIV-infected subjects from baseline (T0), throughout the study: one month after each vaccination dose (T1, T2, T3) and at month 12 and 18 from baseline (T4, T5).

  • lymphoproliferative responses, cytokine production and immunophenotype analysis of lymphocyte subpopulations [ Time Frame: baseline (T0), one month after 1° vaccination dose (T1) and one month after 3° vaccination dose (T3). ] [ Designated as safety issue: No ]

    To evaluate in a subgroup of subjects (20 HIV-infected and 20 healthy) the following immunological parameters at baseline and at 1 month after 1° vaccination dose (T1) and at 1 month after 3° vaccination dose (T3):

    lymphoproliferative responses to HPV-16 L1 from PBMCs in peripheral blood

    Immunophenotype analysis of lymphocyte subpopulations in peripheral blood

    Cytokine production from peripheral lymphocyte subpopulations at baseline and after stimulation with HPV-16 recombinant protein L1.



Estimated Enrollment: 100
Study Start Date: October 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HIV-infected adolescents and young adults
female and male HIV-infected subjects aged from 13-27 years old
Biological: Quadrivalent Human Papillomavirus (6, 11, 16 and 18) vaccine (Gardasil ®)

Human Papillomavirus vaccine (types 6, 11, 16 and 18) (Recombinant, adsorbed).

Each dose of Gardasil suspension for injection contains 0,5 ml. The shot is usually given in the arm muscle, 3 shots are given on the following schedule:

First dose: at chosen date. Second dose: 2 months after dose 1. Third dose: 6 months after dose 1.

Ingredients: highly purified non-infectious protein for each of the Human Papillomavirus types (6, 11, 16 and 18). Each dose (0,5ml) contains approximately:

Human Papillomavirus type 6 L1 protein 20 micrograms. Human Papillomavirus type 11 L1 protein 40 micrograms. Human Papillomavirus type 16 L1 protein 40 micrograms. Human Papillomavirus type 18 L1 protein 20 micrograms.

Active Comparator: healthy adolescents and young adults
female and male healthy adolescents and young adults aged 13-27 years
Biological: Quadrivalent Human Papillomavirus (6, 11, 16 and 18) vaccine (Gardasil ®)

Human Papillomavirus vaccine (types 6, 11, 16 and 18) (Recombinant, adsorbed).

Each dose of Gardasil suspension for injection contains 0,5 ml. The shot is usually given in the arm muscle, 3 shots are given on the following schedule:

first dose: at chosen date. Second dose: 2 months after dose 1. Third dose: 6 months after dose 1.

Ingredients: highly purified non-infectious protein for each of the Human Papillomavirus types (6, 11, 16 and 18). Each dose (0,5ml) contains approximately:

Human Papillomavirus type 6 L1 protein 20 micrograms. Human Papillomavirus type 11 L1 protein 40 micrograms. Human Papillomavirus type 16 L1 protein 40 micrograms. Human Papillomavirus type 18 L1 protein 20 micrograms.


  Eligibility

Ages Eligible for Study:   13 Years to 27 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01512784

Contacts
Contact: Gian Vincenzo Zuccotti, Head Paediatric Department 0039/02/39042253 gianvincenzo.zuccotti@unimi.it
Contact: Gian Vincenzo Zuccotti, Head Paediatrics 0039/02/39042253 gianvincenzo.zuccotti@unimi.it

Locations
Italy
Luigi Sacco Hospital , Department of Paediatrics, via G.B Grassi, 74 Recruiting
Milan, Italy, 20157
Contact: Francesca Penagini, Doctor    0039/02/39042234    frapenagini@tiscali.it   
Sub-Investigator: Alessandra Viganò, Paediatrician         
Sub-Investigator: Francesca Di Nello, Doctor         
Sub-Investigator: Vania Giacomet, Paediatrician         
Principal Investigator: Gian Vincenzo Zuccotti, Full Professor         
Sub-Investigator: Paola Erba, Paediatrician         
Sub-Investigator: Valeria Manfredini, Doctor         
Sponsors and Collaborators
University of Milan
Investigators
Principal Investigator: Gian Vincenzo Zuccotti, Head of Paediatric Department L.Sacco Hospital, via G.B Grassi, 74 20157 Milano, Italy
  More Information

No publications provided

Responsible Party: 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
ClinicalTrials.gov Identifier: NCT01512784     History of Changes
Other Study ID Numbers: HLS04/2011
Study First Received: January 13, 2012
Last Updated: January 18, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by University of Milan:
Quadrivalent Human Papillomavirus Vaccine (HPV) Gardasil
HIV infection
Evaluation of quadrivalent HPV vaccine in adolescents and young adults.

ClinicalTrials.gov processed this record on August 21, 2014