Preparedness Study - HPV Vaccine
21 de janeiro de 2015 atualizado por: H. Lee Moffitt Cancer Center and Research Institute
Preparedness Study: Efficacy of HPV Vaccine to Reduce HIV Infection
Moffitt Cancer Center is the Coordinating Center for this study.
The purpose of this study is to develop and test the infrastructure to conduct a future Phase III vaccine efficacy trial to assess trial feasibility, and to assess human papillomavirus (HPV) genotype distribution, data needed to design a Phase III trial. The investigators propose to conduct a Preparedness study among women ages 16-24 years of age residing in a region of South Africa with a high human immunodeficiency (HIV) incidence and prevalence.
The specific aims of this study are to:
- Identify, recruit, enroll, and randomize a cohort of HIV negative women (200 per arm, 400 total) ages 16-24 years to an HPV vaccine against 4 types (HPV 6, 11, 16, 18 [Gardasil]) or placebo vaccine.
- Determine the cervical HPV prevalence and type distribution at enrollment, and cervical lesion prevalence among young females ages 16-24 years at high risk for HIV infection.
- Assess the rate of compliance through the 3-dose vaccination series
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
The study vaccine will be blindly administered as supplied on Day 1, Month 2, and Month 6.
Both HPV and placebo vaccines will be in identical bottles, and all treatment codes will be kept under lock and key.
All vaccines will be injected intramuscularly into the deltoid muscle by a member of the clinical staff.
Each participant will be monitored for systemic and local reactions for 30 minutes postvaccination after each study vaccination for any adverse effects, including allergic reactions.
Vaccine adverse events will continue to be monitored throughout the duration of the study period.
Vaccine will be shipped to a central pharmacy at Stellenbosch University and stored in a refrigerator monitored and maintained at 2-8 C prior to distribution and local storage at participating clinical centers.
Tipo de estudo
Intervencional
Inscrição (Real)
406
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Florida
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Tampa, Florida, Estados Unidos, 33612
- H. Lee Moffitt Cancer Center and Research Institute
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Parow, África do Sul, 7505
- Stellenbosch University
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
16 anos a 24 anos (Filho, Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
Inclusion Criteria:
- Women ages 16-24 years of age residing in a region of South Africa with a high HIV incidence and prevalence
- HIV negative
- has ever had vaginal intercourse
- has never had Papanicolaou smear (Pap) testing or has only had normal Pap test results
- fully understands study procedures, risks involved in the study, and voluntarily agrees to participate by giving written informed consent
- agrees to refrain from douching/vaginal cleansing and using vaginal medications or preparations for 2 calendar days prior to the Day 1 visit as well as other future visits that include collection of cervical specimens
- agrees to refrain from sexual intercourse for 2 calendar days prior to the Day 1 visit as well as other future visits that include collection of cervical specimens
- agrees to utilize effective contraception during sexual intercourse (excluding the rhythm method, withdrawal alone, and emergency contraception) during the vaccination period.
- Informed consent procedures for females <18 years of age: Informed consent and informed assent will be obtained from parents/legal guardians and adolescents respectively, prior to participation. The consent form will include information about the study and individual request for consent of participants to participate in the study. It will be emphasized that participation is voluntary and that participants are free to withdraw from the study at any stage without any disadvantage to them. An assessment of understanding will be conducted at screening to ensure that consent is informed.
Exclusion Criteria:
- have a history of severe allergic reaction
- have a known allergy to any vaccine component (e.g., aluminum, yeast, or BENZONASE)
- are currently immuno-compromised
- have received a marketed HPV vaccine, or are pregnant and lactating
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: Gardasil Vaccine Administration
Gardasil Vaccine Administration.
Family Health International (FHI) statisticians randomly assigned each participant an allocation number and then subsequently assigned a unique vial identification number for the vial of vaccine the participant should receive at each visit.
A single participant could not be assigned more than 1 allocation number.
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The study vaccine was blindly administered as supplied on Day 1, Month 2, and Month 6.
All vaccines were injected intramuscularly into the deltoid muscle by a member of the clinical staff.
Outros nomes:
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Comparador de Placebo: Placebo Administration
Placebo Administration.
Family Health International (FHI) statisticians randomly assigned each participant an allocation number and then subsequently assigned a unique vial identification number for the vial of vaccine the participant should receive at each visit.
A single participant could not be assigned more than 1 allocation number.
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The study vaccine was blindly administered as supplied on Day 1, Month 2, and Month 6.
All vaccines were injected intramuscularly into the deltoid muscle by a member of the clinical staff.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Human Papillomavirus (HPV) Rate
Prazo: At Enrollment - 5 Month Enrollment Period
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HPV type distribution and prevalence of each HPV type at enrollment.
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At Enrollment - 5 Month Enrollment Period
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Study Compliance Rate
Prazo: 18 Months
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Percentage of participants to complete the 3-dose vaccination series and all 4 study visits.
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18 Months
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Percentage of Participants Who Were Seropositive by HPV Type
Prazo: At Enrollment - 5 Month Enrollment Period
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Percentage of participants who were seropositive to HPV at enrollment, by specific HPV type.
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At Enrollment - 5 Month Enrollment Period
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Percentage of Participants Seroconverted to HPV Types 6, 11, 16, or 18
Prazo: 18 Months
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Percentage of participants who seroconverted to HPV types 6, 11, 16, or 18, following receipt of 3 doses of qHPV vaccine.
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18 Months
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Percentage of Participants Who Seroconverted to HPV Types 31, 33, 45, or 58
Prazo: 18 Months
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The percent of women that seroconverted among those receiving qHPV vaccine compared to placebo vaccine recipients for HPV types 31, 33, 45, and 58, HPV types not directly targeted by the qHPV vaccine.
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18 Months
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Anna Giuliano, Ph.D., H. Lee Moffitt Cancer Center and Research Institute
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Menezes LJ, Pokharel U, Sudenga SL, Botha MH, Zeier M, Abrahamsen ME, Glashoff RH, Engelbrecht S, Schim van der Loeff MF, van der Laan LE, Kipping S, Taylor D, Giuliano AR. Patterns of prevalent HPV and STI co-infections and associated factors among HIV-negative young Western Cape, South African women: the EVRI trial. Sex Transm Infect. 2018 Feb;94(1):55-61. doi: 10.1136/sextrans-2016-053046. Epub 2017 May 10.
- Sudenga SL, Torres BN, Botha MH, Zeier M, Abrahamsen ME, Glashoff RH, Engelbrecht S, Schim Van der Loeff MF, Van der Laan LE, Kipping S, Taylor D, Giuliano AR. HPV SEROSTATUS PRE- AND POST-VACCINATION IN A RANDOMIZED PHASE II PREPAREDNESS TRIAL AMONG YOUNG WESTERN CAPE, SOUTH AFRICAN WOMEN: THE EVRI TRIAL. Papillomavirus Res. 2017 Jun;3:50-56. doi: 10.1016/j.pvr.2017.02.001. Epub 2017 Feb 16.
Links úteis
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de setembro de 2012
Conclusão Primária (Real)
1 de abril de 2014
Conclusão do estudo (Real)
1 de dezembro de 2014
Datas de inscrição no estudo
Enviado pela primeira vez
8 de dezembro de 2011
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de dezembro de 2011
Primeira postagem (Estimativa)
9 de dezembro de 2011
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
6 de fevereiro de 2015
Última atualização enviada que atendeu aos critérios de controle de qualidade
21 de janeiro de 2015
Última verificação
1 de janeiro de 2015
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- MCC-16685
- IISP ID 39582 (Número de outro subsídio/financiamento: Merck)
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