- ICH GCP
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- Ensayo clínico NCT02804711
A Clinical Trial to Evaluate a Recombinant Staphylococcus Aureus Vaccine (Escherichia Coli) in Healthy Adults
A Phase Ia Single-center, Randomized, Double-blind, Placebo Controlled, Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of a Recombinant Staphylococcus Aureus Vaccine (Escherichia Coli) in Healthy Adults Aged 18-65 Years in China
Before this study, there will be an open-label, dose-escalation pilot study with a total of 30 participants with 10 per dosage group. The aim of the pilot study is to explore the preliminary safety of an experimental recombinant staphylococcus aureus vaccine.
This is a single center, double-blind, placebo control, dose-escalation phase 1 clinical trial. This study will determine the safety and side-effect profile, and immunogenicity of an experimental recombinant staphylococcus aureus vaccine. The study will be carried out following a dose-escalation method from the low dosage to the high dosage, i.e. the higher dosage vaccine could only be administrated after the first seven-day safety of the lower dosage vaccine is confirmed after safety observation.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Jiangsu
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Taixing, Jiangsu, Porcelana, 210009
- Xiaokui Hu
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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 volunteers aged 18 to 65 years (aged over 18 and under 66 years).
- Able to comply with all clinical trial protocol requirements and willing to complete all the visit plan process during the whole clinical trial observation period.
- Able to understand the content of informed consent and willing to sign the informed consent.
- Able to complete the diary card independently.
- For females only (18-49 years), a negative urine pregnancy test and willing to practice continuous effective contraception during the study.
- Axillary temperature ≤37.0°C.
Exclusion Criteria:
First Immunization exclusion standard:
- Prior receipt of Staphylococcus aureus vaccine
- Any confirmed Staphylococcus aureus infection disease in the past 12 month.
- History of asthma, hereditary angioneurotic edema, diabetes, malignancy or other serious disease. Participation in the clinical trial is likely to increase the disease risk and interfere with the observation of clinical trial index.
- Prior blood donation or Blood loss over 400ml in the last 3 months;
- Coagulation disorders (coagulation factor deficiency, coagulopathy or platelet disorder) diagnosed by doctors, or obvious bruises or blood coagulation noticed.
- History of allergic disease likely to be exacerbated by any component of the vaccine, including allergy, urticaria, respiratory difficulty, angioneurotic edema or abdominal pain.
- Any autoimmune disease or immunodeficient state, parents, brother and sister with autoimmune disease or immunodeficient disease.
- Taking immunoglobulins and/or any blood products within the last 12 months.
- Asplenia, functional asplenia or asplenia caused by any situation or splenectomy.
- Any acute disease or acute attack of chronic disease in last 7 days.
- History of thyroidectomy or thyroid disease requiring treatment in the last 12 months.
- Immunosuppressor, cytotoxic therapy, inhaled corticosteroid (excluding corticosteroids spray treatment of allergic rhinitis, acute and non-concurrent corticosteroids treatment)
- Participation in another research study involving receipt of an investigational product in the last 30 days.
- Woman who is breast-feeding.
- Prior administration of attenuated vaccine in last 28 days.
- Prior administration of subunit vaccine, inactivated vaccine or allergic therapy in last 14 days.
- Current anti-tuberculosis prophylaxis or therapy
- Any other conditions may compromise the safety or availability of participants in the judgment of the investigator.
Following Immunization exclusion standard:
- Any grade 3 or more serious adverse reaction happen since the last vaccination.
- Other condition violates the inclusion criteria or meets the exclusion criteria is noticed after the first immunization.
- Acute or chronic infections at the vaccination day (axillary temperature>37.0°C).
- According to the investigator, the participant should not continue participating in the study.
Plan de estudios
¿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 |
---|---|
Experimental: Four doses of low dose vaccine
four doses of 15µg/0.6ml
per dose
|
|
Experimental: Four doses of middle dose vaccine
four doses of 30µg/0.6ml
per dose
|
|
Experimental: Four doses of high dose vaccine
four doses of 60µg/0.6ml
per dose
|
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Experimental: Three doses of low dose vaccine and one dose of placebo
three doses of 15µg/0.6ml
per dose and one dose of placebo
|
|
Experimental: Three doses of middle dose vaccine and one dose of placebo
three doses of 30µg/0.6ml
per dose and one dose of placebo
|
|
Experimental: Three doses of high dose vaccine and one dose of placebo
three doses of 60µg/0.6ml
per dose and one dose of placebo
|
|
Comparador de placebos: Four doses of placebo
four doses of placebo
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Occurrence of injection site adverse reactions after vaccination
Periodo de tiempo: within 21 days after the vaccination
|
Occurrence of solicited injection site adverse reactions within 21 days after vaccination with the Recombinant Staphylococcus aureus vaccine
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within 21 days after the vaccination
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Occurrence of systematic adverse reactions after vaccination
Periodo de tiempo: within 21 days after the vaccination
|
Occurrence of solicited systematic adverse reactions within 21 days after vaccination with the Recombinant Staphylococcus aureus vaccine
|
within 21 days after the vaccination
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Aparición de eventos adversos graves después de la vacunación.
Periodo de tiempo: dentro de los 6 meses posteriores a la vacunación
|
Aparición de eventos adversos graves dentro de los 6 meses posteriores a la vacunación con la vacuna recombinante Staphylococcus aureus
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dentro de los 6 meses posteriores a la vacunación
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Occurrence of unsolicited adverse reactions after vaccination.
Periodo de tiempo: within 42 days after the vaccination
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Occurrence of unsolicited adverse reactions within 42 days after vaccination with the Recombinant Staphylococcus aureus vaccine
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within 42 days after the vaccination
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Changes of the blood routine after vaccination.
Periodo de tiempo: day 0-17 after the vaccination
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Changes of the blood routine after vaccination with the Recombinant Staphylococcus aureus vaccine on day 3, 7, 10, 14 and 17.
|
day 0-17 after the vaccination
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Changes of the blood biochemistry after vaccination.
Periodo de tiempo: day 0-17 after the vaccination
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Changes of the blood biochemistry after vaccination with the Recombinant Staphylococcus aureus vaccine on day 3, 7, 10, 14 and 17.
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day 0-17 after the vaccination
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Geometric mean titre against specific antigens
Periodo de tiempo: within 6 months after the vaccination
|
Geometric mean titre measured at day 0, 7, 14, 21, 42 and month 3, 6.
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within 6 months after the vaccination
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Geometric mean fold increase against specific antigens
Periodo de tiempo: within 6 months after the vaccination
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Geometric mean fold increase measured at day 7, 14, 21, 42 and month 3, 6.
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within 6 months after the vaccination
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Positive conversion rate of serum against specific antigens
Periodo de tiempo: within 6 months after the vaccination
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Positive conversion rate of serum measured at day 7, 14, 21, 42 and month 3, 6.
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within 6 months after the vaccination
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Changes of the colonization of Staphylococcus aureus on nasal mucosus after vaccination.
Periodo de tiempo: within 6 months after the vaccination
|
Changes of the colonization of Staphylococcus aureus on nasal mucosus after vaccination with the Staphylococcus aureus vaccine at day at day 3, 7, 10, 14, 17, 21, 42 and month 3, 6.
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within 6 months after the vaccination
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Specific functional antibody responses to the Staphylococcus aureus vaccine
Periodo de tiempo: within 6 months after the vaccination
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Specific functional antibody responses to the Staphylococcus aureus vaccine at day 7, 14, 21, 42 and month 3, 6.
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within 6 months after the vaccination
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Specific T cell immune responses to the Staphylococcus aureus vaccine.
Periodo de tiempo: within 6 months after the vaccination
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Specific T cell immune responses to the Staphylococcus aureus vaccine at day at day7, 14, 21, 42 and month 3, 6 measured by ELISpot.
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within 6 months after the vaccination
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Colaboradores e Investigadores
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
- Infecciones
- Infecciones por bacterias gramnegativas
- Infecciones bacterianas
- Infecciones bacterianas y micosis
- Infecciones por bacterias grampositivas
- Infecciones por enterobacterias
- Infecciones estafilocócicas
- Infecciones por Escherichia coli
- Efectos fisiológicos de las drogas
- Factores inmunológicos
- Vacunas
Otros números de identificación del estudio
- JSVCT027
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. .
Ensayos clínicos sobre Infección por Staphylococcus Aureus
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Ohio State UniversityTerminadoStaphylococcus aureus resistente a la meticilina | Infección por Staphylococcus aureus sensible a la meticilinaEstados Unidos
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Forest LaboratoriesTerminadoBacteriemia por Staphylococcus aureus | Staphylococcus aureus resistente a la meticilina (MRSA) BacteriemiaEstados Unidos
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Todd C. Lee MD MPH FIDSAAún no reclutandoBacteriemia por Staphylococcus aureus | Endocarditis por Staphylococcus aureus | Staphylococcus aureus Septicemia | Sepsis estafilocócicaCanadá
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Intron Biotechnology, Inc.TerminadoVoluntarios Saludables | Agentes antibacterianos | Staphylococcus aureus resistente a la meticilina | Infección por Staphylococcus aureus sensible a la meticilinaCorea, república de
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Menzies School of Health ResearchThe University of Queensland; Australasian Society for Infectious Diseases; Singapore... y otros colaboradoresTerminadoStaphylococcus aureus resistente a la meticilinaAustralia, Nueva Zelanda, Israel, Singapur
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University of PennsylvaniaRetiradoBacteriemia por Staphylococcus aureus | Endocarditis por Staphylococcus aureusEstados Unidos
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University of PennsylvaniaChildren's Hospital of Philadelphia; Milton S. Hershey Medical Center; Pennsylvania...TerminadoMRSA - Infección por Staphylococcus Aureus resistente a la meticilinaEstados Unidos
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Massachusetts General HospitalTerminadoMRSA - Infección por Staphylococcus Aureus resistente a la meticilinaEstados Unidos
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Armata Pharmaceuticals, Inc.United States Department of DefenseReclutamientoBacteriemia | Estafilococo aureus | Bacteriemia por Staphylococcus aureus | Bacteriemia por Staphylococcus Aureus | Bacteriemia estafilococoEstados Unidos, Australia
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University College, LondonKing's College London; Rambam Health Care Campus; University of Melbourne; Menzies... y otros colaboradoresAún no reclutandoSepticemia | Infección por Staphylococcus Aureus | Infección del torrente sanguíneo | Bacteriemia por Staphylococcus aureus | Sepsis bacteriana | Staphylococcus aureus Septicemia | Sepsis por estafilococo