Long Term Immunogenicity of Quadrivalent Human Papillomavirus Vaccine (Gardasil®)in HIV-infected Adolescents and Young Adults
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
Visão geral do estudo
Status
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Fase 3
Contactos e Locais
Locais de estudo
-
-
-
Milan, Itália, 20157
- Recrutamento
- Luigi Sacco Hospital , Department of Paediatrics, via G.B Grassi, 74
-
Contato:
- Francesca Penagini, Doctor
- Número de telefone: 0039/02/39042234
- E-mail: frapenagini@tiscali.it
-
Subinvestigador:
- Alessandra Viganò, Paediatrician
-
Subinvestigador:
- Francesca Di Nello, Doctor
-
Subinvestigador:
- Vania Giacomet, Paediatrician
-
Investigador principal:
- Gian Vincenzo Zuccotti, Full Professor
-
Subinvestigador:
- Paola Erba, Paediatrician
-
Subinvestigador:
- Valeria Manfredini, Doctor
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: HIV-infected adolescents and young adults
female and male HIV-infected subjects aged from 13-27 years old
|
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. 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. |
|
Comparador Ativo: healthy adolescents and young adults
female and male healthy adolescents and young adults aged 13-27 years
|
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. 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
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
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
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
Prazo: 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).
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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).
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Gian Vincenzo Zuccotti, Head of Paediatric Department, L.Sacco Hospital, via G.B Grassi, 74 20157 Milano, Italy
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- HLS04/2011
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .