Preparedness Study - HPV Vaccine
21 de enero de 2015 actualizado 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
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Actual)
406
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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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, Sudáfrica, 7505
- Stellenbosch University
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
16 años a 24 años (Niño, Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: 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.
Otros nombres:
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Comparador de placebos: 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.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Human Papillomavirus (HPV) Rate
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Study Compliance Rate
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Anna Giuliano, Ph.D., H. Lee Moffitt Cancer Center and Research Institute
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de septiembre de 2012
Finalización primaria (Actual)
1 de abril de 2014
Finalización del estudio (Actual)
1 de diciembre de 2014
Fechas de registro del estudio
Enviado por primera vez
8 de diciembre de 2011
Primero enviado que cumplió con los criterios de control de calidad
8 de diciembre de 2011
Publicado por primera vez (Estimar)
9 de diciembre de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
6 de febrero de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
21 de enero de 2015
Última verificación
1 de enero de 2015
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MCC-16685
- IISP ID 39582 (Otro número de subvención/financiamiento: Merck)
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