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

NCT ID: NCT01512784

Last Updated: 2012-01-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-07-31

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.

Conditions

HPV; HIV

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

HIV-infected adolescents and young adults

female and male HIV-infected subjects aged from 13-27 years old

Group Type: EXPERIMENTAL

Quadrivalent Human Papillomavirus (6, 11, 16 and 18) vaccine (Gardasil ®)

Intervention Type: BIOLOGICAL

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.

healthy adolescents and young adults

female and male healthy adolescents and young adults aged 13-27 years

Group Type: ACTIVE_COMPARATOR

Quadrivalent Human Papillomavirus (6, 11, 16 and 18) vaccine (Gardasil ®)

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 27 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Milan

OTHER

Sponsor Role: lead

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gian Vincenzo Zuccotti, Head of Paediatric Department

Role: PRINCIPAL_INVESTIGATOR

L.Sacco Hospital, via G.B Grassi, 74 20157 Milano, Italy

Locations

Luigi Sacco Hospital , Department of Paediatrics, via G.B Grassi, 74

Milan, Italy, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Gian Vincenzo Zuccotti, Head Paediatric Department

Role: CONTACT

gianvincenzo.zuccotti@unimi.it

0039/02/39042253

Gian Vincenzo Zuccotti, Head Paediatrics

Role: CONTACT

gianvincenzo.zuccotti@unimi.it

0039/02/39042253

Facility Contacts

Francesca Penagini, Doctor

Role: primary

frapenagini@tiscali.it

0039/02/39042234

Other Identifiers

HLS04/2011

Identifier Type: -

Identifier Source: org_study_id