- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02362217
A Study to Assess the Safety of HIV and Hep C Vaccine Candidates When Given Separately or in Combination
A Phase I Study to Evaluate the Safety and Immunogenicity of Simultaneous Prime-Boost Immunisations With Candidate HCV and HIV-1 Vaccines, AdCh3NSmut1 / ChAdV63.HIVconsv and MVA-NSmut / MVA.HIVconsv, in Healthy Volunteers
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Hepatitis C and HIV are both widespread pathogens. By the end of 2010, there were 2.3 million people in Europe living with HIV, over half of whom were coinfected with the Hepatitis C virus (HCV). Although vaccination is the optimal method of preventing infection, it has proved extremely difficult to develop an effective vaccine against HIV and HCV due to the enormous variation in strains around the world. This is caused by the extraordinary ability of the viruses to change their genetic material.
Researchers at the University of Oxford have developed novel candidate vaccines against HIV ('HIV.consv') and HCV ('NSmut'). These vaccines have been inserted into the carrier viruses Chimpanzee Adenovirus (ChAd or AdCh) and modified vaccinia virus Ankara (MVA), both of which have excellent safety records. The aim of this study is to test for the first time the response of the immune system when vaccines to both HIV and HCV are given together.
During this study, 32 healthy adults aged 18 to 50 years will be recruited into one of three groups to receive either two or four intramuscular injections over a period of two months. All participants will be followed up for a further six months (12 visits in total).
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Oxfordshire
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Oxford, Oxfordshire, Reino Unido, OX3 7LE
- Centre for Clinical Vaccinology and Tropical Medicine
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Healthy males or females, as assessed by medical history, physical examination and laboratory tests
- Aged at least 18 years on the day of screening and no greater than 50 years on the day of the first vaccination
- Resident in or easy access to the trial site for the duration of the study
- Available for follow-up for the planned duration of the study
- Able and willing (in the Chief Investigator's opinion) to comply with all study requirements
- Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner
- For females, willingness to practice continuous effective contraception from screening until 4 months after the last immunisation.
- All female volunteers must be willing to undergo urine pregnancy tests at the time points specified in the Schedule of Procedures and must have a negative pregnancy test on the day(s) of vaccination
- For sexually active men, willingness to use an approved method of contraception until four months after the last vaccination
- Agreement to refrain from blood donation during the course of the study
- In the opinion of the Chief Investigator or designee, the volunteer has understood the information provided. Written informed consent must be given before any study-related procedures are performed
- Willing to undergo HCV/HIV-1 testing, counselling and receive test results
Exclusion Criteria:
- Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned use during the study period
- Prior receipt of a recombinant simian adenoviral vaccine
- Receipt of any investigational HIV-1 or HCV vaccine within the last 6 years
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
- Receipt of live attenuated vaccine within the previous 60 days or planned receipt within 60 days after vaccination with the IMP
- Receipt of other vaccine, including influenza vaccine, within the previous 14 days or planned receipt within 14 days after vaccination with the IMP
- Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressive medication within the past 6 months (inhaled and topical steroids are allowed)
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
- History of clinically significant contact dermatitis
- Any history of anaphylaxis in reaction to vaccination
- Pregnancy, lactation or intention to become pregnant during the study
- History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
- History of serious psychiatric condition
- Any other serious chronic illness requiring hospital specialist supervision
- Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
- Suspected or known injecting drug use
- Reported high-risk behaviour for HIV-1 / HCV infection
- Seropositive for hepatitis B surface antigen (HBsAg)
- Seropositive for HIV-1 (antibodies to HIV-1) at screening
- Seropositive for hepatitis C virus (antibodies to HCV) at screening
- Any other clinically significant acute or chronic medical condition that is considered unstable/progressive, or in the opinion of the Chief Investigator, may either put the volunteer at risk because of participation in the study, or may influence the result of the study, or the volunteer's ability to participate in the study
- Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis
- Any other finding which in the opinion of the investigators would significantly increase the risk of having an adverse outcome from participating in the protocol
- Vulnerable subjects (according to ICH GCP)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Group 1
Interventions: AdCh3NSmut1, MVA-NSmut. Administration schedule: 1 dose AdCh3NSmut1 2.5 x 10^10 vp at week 0 and 1 dose MVA-NSmut 2 x 10^8 pfu at week 8. Subjects: 8 healthy volunteers. |
Vacuna genética contra la infección por el virus de la Hepatitis C
Vacuna genética contra la infección por el virus de la Hepatitis C
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Experimental: Group 2
Interventions: ChAdV63.HIVconsv, MVA.HIVconsv. Administration schedule: 1 dose ChAdV63.HIVconsv 5 x 10^10 vp at week 0 and 1 dose MVA.HIVconsv 2 x 10^8 pfu at week 8. Subjects: 8 healthy volunteers. |
Genetic vaccine against HIV-1 infection
Genetic vaccine against HIV-1 infection
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Experimental: Group 3
Interventions: AdCh3NSmut1, MVA-NSmut, ChAdV63.HIVconsv, MVA.HIVconsv. Administration schedule: 1 dose AdCh3NSmut1 2.5 x 10^10 vp and 1 dose ChAdV63.HIVconsv 5 x 10^10 vp at week 0, and 1 dose MVA-NSmut 1 x 10^8 pfu and 1 dose MVA.HIVconsv 1 x 10^8 pfu at week 8. Subjects: 16 healthy volunteers. |
Vacuna genética contra la infección por el virus de la Hepatitis C
Vacuna genética contra la infección por el virus de la Hepatitis C
Genetic vaccine against HIV-1 infection
Genetic vaccine against HIV-1 infection
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Safety of administering simultaneous HCV/HIV-1 prime-boost vaccinations, as measured by the proportion of volunteers who develop a grade 3 or 4 local or systemic reaction
Periodo de tiempo: Actively collected throughout the study until 6 months after the last vaccination
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Proportion of volunteers who develop a grade 3 or 4 local reaction Proportion of volunteers who develop a grade 3 or 4 systemic reaction
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Actively collected throughout the study until 6 months after the last vaccination
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Cellular immune response generated by simultaneous HCV/HIV-1 prime-boost vaccinations, as determined by analysing changes in the magnitude or quality of HCV and HIV-1-specific cellular immune responses.
Periodo de tiempo: Actively collected throughout the study until 6 months after the last vaccination
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Immunogenicity determined by analysing changes from baseline in the magnitude or quality of HCV and HIV-1-specific cellular immune responses.
These will be detected using several standardised assays.
The primary outcome measure for immunogenicity will be the development of T cell responses to HCV and HIV-1 epitopes, as determined by IFN-ɣ ELISpot assay.
In addition, several exploratory immunology assays (including but not limited to intracellular cytokine staining, phenotype, viral suppression in vitro) will be developed and used.
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Actively collected throughout the study until 6 months after the last vaccination
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Lucy Dorrell, Prof., University of Oxford
- Investigador principal: Ellie Barnes, Prof., University of Oxford
- Investigador principal: Tomas Hanke, Prof., University of Oxford
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Procesos Patológicos
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones transmitidas por la sangre
- Atributos de la enfermedad
- Enfermedades del HIGADO
- Infecciones por Flaviviridae
- Hepatitis, Viral, Humana
- Hepatitis
- Infecciones
- Enfermedades contagiosas
- Hepatitis C
Otros números de identificación del estudio
- PEACHI-04
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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Ensayos clínicos sobre AdCh3NSmut1
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University of OxfordGlaxoSmithKline; Cantonal Hospital of St. Gallen; St. James's Hospital, Ireland; ReiThera...TerminadoInfección por hepatitis CSuiza, Irlanda
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ReiThera SrlUniversity of Oxford; Oxford University Hospitals NHS Trust; University Hospital...TerminadoInfección por hepatitis CReino Unido