- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01623557
A Challenge Study to Assess the Protective Efficacy of Two Malaria Vaccine Candidates (VAC045)
A Phase I/IIa Sporozoite Challenge Study to Assess the Protective Efficacy of Two Prime-Boost Malaria Vaccine Candidates: ChAd63 and MVA Encoding ME-TRAP and the Same Viral Vectors Encoding CS
This study aims to assess the safety and effectiveness of four new candidate malaria vaccines; ChAd63 CS, ChAd63 ME-TRAP, MVA CS & MVA ME-TRAP. These vaccines consist of viruses (ChAd63 and MVA) which have been genetically modified so (i) they cannot replicate in humans and (ii) they include parts of the malaria parasite; Plasmodium falciparum (CS and ME-TRAP). The hope is that these vaccines will induce immune responses in vaccinees that are able to prevent malaria.
This proposed study will compare how effective ChAd63-MVA CS is at preventing malaria infection in UK volunteers following malaria challenge compared to ChAd63-MVA ME-TRAP.
The study will be conducted at the University of Oxford's Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Oxford, UK and the Wellcome Trust Clinical Research Facility in Southampton, UK. The malaria challenge will take place at the insectary at Imperial College (Infection and Immunity Section) in London, UK.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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London, Reino Unido, SW7 2AZ
- Infection and Immunity Section, Imperial College of Science, Technology and Medicine
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Southampton, Reino Unido, SO16 6YD
- Wellcome Trust CRF, Southampton General Hospital
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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 adults aged 18 to 45 years.
- Able and willing (in the 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.
- Women only: Must practice continuous effective contraception for the duration of the study.
- Agreement to refrain from blood donation during the course of the study and for at least 3 years after the end of their involvement in the study.
- Written informed consent to participate in the trial.
- Reachable (24/7) by mobile phone during the period between CHMI and completion of antimalarial treatment.
- Willingness to take a curative anti-malaria regimen following CHMI.
- For volunteers not living in Oxford: agreement to stay in a hotel room close to the trial centre during a part of the study (from at least day 6.5 post mosquito bite until anti-malarial treatment is completed).
- Answer all questions on the informed consent quiz correctly.
Exclusion Criteria:
- History of clinical malaria (any species).
- Travel to a malaria endemic region during the study period or within the preceding six months with significant risk of malaria exposure.
- Use of systemic antibiotics with known antimalarial activity within 30 days of CHMI (e.g. trimethoprim-sulfamethoxazole, doxycycline, tetracycline, clindamycin, erythromycin, fluoroquinolones and azithromycin)
- Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt during the study period.
- Prior receipt of an investigational malaria vaccine or any other investigational vaccine likely to impact on interpretation of the trial data.
- Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed).
- Use of immunoglobulins or blood products within 3 months prior to enrolment.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine (e.g. egg products, Kathon) or malaria infection.
- Any history of anaphylaxis post vaccination.
- History of clinically significant contact dermatitis.
- History of sickle cell anaemia, sickle cell trait, thalassemia or thalassemia trait or any haematological condition that could affect susceptibility to malaria infection.
- Pregnancy, lactation or intention to become pregnant during the study.
- Contraindications to the use of all three proposed anti-malarial medications; Malarone, Riamet and Chloroquine.
- History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
- History of serious psychiatric condition that may affect participation in the study.
- 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 abuse in the 5 years preceding enrolment.
- Seropositive for hepatitis B surface antigen (HBsAg).
- Seropositive for hepatitis C virus (antibodies to HCV) with positive PCR for hepatitis C at screening.
- An estimated, ten year risk of fatal cardiovascular disease of ≥5%, as estimated by the Systematic Coronary Risk Evaluation (SCORE) system.76
- Positive family history in 1st and 2nd degree relatives < 50 years old for cardiac disease.
- Volunteers unable to be closely followed for social, geographic or psychological reasons.
- Any clinically significant abnormal finding on biochemistry or haematology blood tests, urinalysis or clinical examination.
- Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Group 1: ChAd63-MVA CS
1 dose of ChAd63 CS 5 x 10^10 vp intramuscularly and 1 dose MVA CS 2 x 10^8 pfu intramuscularly 8 weeks later.
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1 dose of ChAd63 CS 5 x 10^10 vp intramuscularly and 1 dose MVA CS 2 x 10^8 pfu intramuscularly 8 weeks later.
Approximately 3 weeks post MVA dosing
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Comparador activo: Group 2: ChAd63-MVA ME-TRAP
1 dose of ChAd63 ME-TRAP 5 x 10^10 vp intramuscularly and 1 dose MVA ME-TRAP 2 x 10^8 pfu intramuscularly 8 weeks later.
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Approximately 3 weeks post MVA dosing
1 dose of ChAd63 ME-TRAP 5 x 10^10 vp intramuscularly and 1 dose MVA ME-TRAP 2 x 10^8 pfu intramuscularly 8 weeks later.
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Comparador activo: Group 3: Unvaccinated Infectivity Controls
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Approximately 3 weeks post MVA dosing
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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The effectiveness of ChAd63-MVA CS and ChAd63-MVA ME-TRAP at preventing malaria infection
Periodo de tiempo: Up to 30 days post challenge
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Comparison of the number of individuals who develop malaria infection between vaccinees and unvaccinated control volunteers.
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Up to 30 days post challenge
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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The safety and immunogenicity of ChAd63-MVA CS and ChAd63-MVA ME-TRAP
Periodo de tiempo: up to 7 months post first vaccination
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The safety of the vaccine regimens will be assessed by analysing actively and passively collected data from clinical review of volunteers and laboratory measurements. The ability of the vaccines to induce malaria-specific immune responses (immunogenicity) will be assessed by the following laboratory tests; (A) Interferon gamma ELISPOT. (B) Flow cytometry to measure T cell responses Other laboratory investigations including microarray analysis may be performed. |
up to 7 months post first vaccination
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Adrian V S Hill, MD, University of Oxford
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- VAC045
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University of OxfordTerminado
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University of OxfordTerminadoPaludismo por Plasmodium falciparumReino Unido
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University of OxfordEuropean and Developing Countries Clinical Trials Partnership (EDCTP)Terminado
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University of OxfordTerminado
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University of OxfordEuropean and Developing Countries Clinical Trials Partnership (EDCTP)Terminado