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

18 januari 2012 bijgewerkt door: Gian Vincenzo Zuccotti, University of Milan

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

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.

Studie Overzicht

Toestand

Onbekend

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Verwacht)

100

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Italië
      • Milan, Italië, 20157
        • Werving
        • Luigi Sacco Hospital , Department of Paediatrics, via G.B Grassi, 74
        • Contact:
        • Onderonderzoeker:
          • Alessandra Viganò, Paediatrician
        • Onderonderzoeker:
          • Francesca Di Nello, Doctor
        • Onderonderzoeker:
          • Vania Giacomet, Paediatrician
        • Hoofdonderzoeker:
          • Gian Vincenzo Zuccotti, Full Professor
        • Onderonderzoeker:
          • Paola Erba, Paediatrician
        • Onderonderzoeker:
          • Valeria Manfredini, Doctor

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

13 jaar tot 27 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: HIV-infected adolescents and young adults
female and male HIV-infected subjects aged from 13-27 years old
Biologisch: 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.

Biologisch: 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.
Actieve vergelijker: healthy adolescents and young adults
female and male healthy adolescents and young adults aged 13-27 years
Biologisch: 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.

Biologisch: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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
Tijdsspanne: 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.
one month +/- 10 days after 3° vaccine dose

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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
Tijdsspanne: one month +/- 10 days after 1°vaccine dose and month+/- 10 days after 2° vaccine dose
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.
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).
Tijdsspanne: 12 months +/- 10 days and 18 months +/-10 days from baseline
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).
12 months +/- 10 days and 18 months +/-10 days from baseline
local and systemic adverse events
Tijdsspanne: 7 days after each vaccination dose
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.
7 days after each vaccination dose
HIV viral load and lymphocyte CD4+ count
Tijdsspanne: baseline (T0), one month after each vaccination dose (T1, T2 and T3) and at month 12 (T4) and 18 (T5) from baseline.
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).
baseline (T0), one month after each vaccination dose (T1, T2 and T3) and at month 12 (T4) and 18 (T5) from baseline.
lymphoproliferative responses, cytokine production and immunophenotype analysis of lymphocyte subpopulations
Tijdsspanne: baseline (T0), one month after 1° vaccination dose (T1) and one month after 3° vaccination dose (T3).

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.
baseline (T0), one month after 1° vaccination dose (T1) and one month after 3° vaccination dose (T3).

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Milan

Onderzoekers

  • Hoofdonderzoeker: Gian Vincenzo Zuccotti, Head of Paediatric Department, L.Sacco Hospital, via G.B Grassi, 74 20157 Milano, Italy

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 oktober 2011

Primaire voltooiing (Verwacht)

1 juli 2013

Studie voltooiing (Verwacht)

1 juli 2013

Studieregistratiedata

Eerst ingediend

13 januari 2012

Eerst ingediend dat voldeed aan de QC-criteria

18 januari 2012

Eerst geplaatst (Schatting)

19 januari 2012

Updates van studierecords

Laatste update geplaatst (Schatting)

19 januari 2012

Laatste update ingediend die voldeed aan QC-criteria

18 januari 2012

Laatst geverifieerd

1 januari 2012

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • HLS04/2011

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