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

NCT01512784 | Unknown Phase 3

• 1 other identifier: HLS04/2011
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Quadrivalent Human Papillomavirus Vaccine (HPV) Gardasil; HIV infection; Evaluation of quadrivalent HPV vaccine in adolescents and young adults.

Outcome Measures

Primary Outcomes (1)

• 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

  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

Secondary Outcomes (5)

• 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

  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).

  12 months +/- 10 days and 18 months +/-10 days from baseline

• local and systemic adverse events

  7 days after each vaccination dose

• HIV viral load and lymphocyte CD4+ count

  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

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

Study Arms (2)

HIV-infected adolescents and young adults

EXPERIMENTAL

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

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

healthy adolescents and young adults

ACTIVE COMPARATOR

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

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

Interventions

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

HIV-infected adolescents and young adults

Eligibility Criteria

• Age: 13 Years - 27 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

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

Milan, Italy, 20157, Italy

RECRUITING

MeSH Terms

Conditions

Papillomavirus Infections; HIV Infections

Interventions

Vaccines; Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures; Vaccines, Combined; Papillomavirus Vaccines; Viral Vaccines

Study Officials

• Gian Vincenzo Zuccotti, Head of Paediatric Department

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gian Vincenzo Zuccotti, Head Paediatric Department

CONTACT

0039/02/39042253; gianvincenzo.zuccotti@unimi.it

Gian Vincenzo Zuccotti, Head Paediatrics

CONTACT

0039/02/39042253; gianvincenzo.zuccotti@unimi.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI 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

Study Record Dates

• First Submitted: January 13, 2012
• First Posted: January 19, 2012
• Study Start: October 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: January 19, 2012

Record last verified: 2012-01

Locations

IT (1)