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

University of Milan

Status and phase: Unknown; Phase 3

Conditions: HPV; HIV

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01512784

HLS04/2011

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 13 to 27 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

HIV-infected adolescents and young adults

Experimental group

Description:

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

Treatment:

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

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

healthy adolescents and young adults

Active Comparator group

Description:

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

Treatment:

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

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