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

18 janvier 2012 mis à jour par: 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.

Aperçu de l'étude

Statut

Inconnue

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Anticipé)

100

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Italie
      • Milan, Italie, 20157
        • Recrutement
        • Luigi Sacco Hospital , Department of Paediatrics, via G.B Grassi, 74
        • Contact:
        • Sous-enquêteur:
          • Alessandra Viganò, Paediatrician
        • Sous-enquêteur:
          • Francesca Di Nello, Doctor
        • Sous-enquêteur:
          • Vania Giacomet, Paediatrician
        • Chercheur principal:
          • Gian Vincenzo Zuccotti, Full Professor
        • Sous-enquêteur:
          • Paola Erba, Paediatrician
        • Sous-enquêteur:
          • Valeria Manfredini, Doctor

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

13 ans à 27 ans (Enfant, Adulte)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: HIV-infected adolescents and young adults
female and male HIV-infected subjects aged from 13-27 years old
Biologique: 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.

Biologique: 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.
Comparateur actif: healthy adolescents and young adults
female and male healthy adolescents and young adults aged 13-27 years
Biologique: 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.

Biologique: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
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
Délai: 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).
Délai: 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
Délai: 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
Délai: 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
Délai: 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).

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Milan

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 octobre 2011

Achèvement primaire (Anticipé)

1 juillet 2013

Achèvement de l'étude (Anticipé)

1 juillet 2013

Dates d'inscription aux études

Première soumission

13 janvier 2012

Première soumission répondant aux critères de contrôle qualité

18 janvier 2012

Première publication (Estimation)

19 janvier 2012

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

19 janvier 2012

Dernière mise à jour soumise répondant aux critères de contrôle qualité

18 janvier 2012

Dernière vérification

1 janvier 2012

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • HLS04/2011

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