- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01897701
A(H7N9) VLP Antigen Dose Ranging Study With Adjuvant 1
A Phase 1 Randomized, Observer-Blinded, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of Monovalent A/Anhui/1/2013 (H7N9) Virus-Like Particle (VLP) Avian Influenza Antigen (Recombinant) in Healthy Adults With and Without Adjuvant 1
This is a randomized, observer-blinded, placebo-controlled trial in adults ≥18 years old. Randomization will be stratified by age (18 to 49 years and ≥50 years) and by prior influenza immunization within the past three months. Proportions of subjects in the various strata will not be pre-specified; rather, the goal will be to achieve an approximately equal distribution of subjects with these characteristics across the various treatment groups.
Treatments will comprise two identical IM doses at a 21-day interval (Day 0 and Day 21), in alternate deltoids. For each subject, study follow-up will span approximately 385 days total, or approximately 13 months from the first dose.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Queensland
-
Herston, Queensland, Australia, 4006
- Q-Pharm Pty Limited
-
-
South Australia
-
Adelaide, South Australia, Australia, 5000
- CMAX
-
-
Western Australia
-
Nedlands, Western Australia, Australia, 6009
- Linear Clinical Research
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
Subjects must meet all of the following to be eligible for participation in the study:
- Healthy adult male or female, ≥18 years of age,
- Willing and able to give informed consent prior to study enrollment,
- Able to comply with study requirements, and
- Women of childbearing potential must have a negative urine pregnancy test prior to each vaccination, will be advised through the Informed Consent process to avoid becoming pregnant over the duration of the study, and must assert that they will employ an effective form of birth control for the duration of the study. Acceptable forms of birth control are: credible history of continuous abstinence from heterosexual activity or prior surgical sterilization, hormonal contraceptives (oral, injectable, implant, patch, ring), barrier contraceptives (condom or diaphragm), and intrauterine device (IUD). Women with an adequately documented history of surgical sterility, or ≥50 years of age and without menses for ≥ 1 year are exempt from urine pregnancy testing.
Exclusion Criteria:
Subjects meeting any of the following criteria are not eligible for participation in the study.
Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care.
- Asymptomatic conditions or findings (e.g., mild hypertension, dyslipidemia) that are not associated with evidence of end-organ damage are not exclusionary provided that they are being appropriately managed and are clinically stable (i.e., unlikely to result in symptomatic illness within the time-course of this study) in the opinion of the investigator.
- Note that illnesses or conditions may be exclusionary, even if otherwise stable, due to therapies used to treat them (see exclusion criteria 2, 5, 7, 8).
- Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of first vaccination.
- History of a serious reaction to prior influenza vaccination.
- History of Guillain-Barré Syndrome (GBS) within 6 weeks following a previous influenza vaccine.
- Received any vaccine in the 4 weeks preceding the study vaccination; or any A(H7N9) avian influenza vaccine at any time.
- Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination.
- Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
- Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature >38.0°C on the planned day of vaccine administration).
- Known disturbance of coagulation.
- Women who are pregnant or breastfeeding, or plan to become pregnant during the study.
- Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse.
- Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled or could interfere with evaluation of the vaccine or interpretation of study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting).
- Persons employed in a capacity that involves handling poultry or wild birds.
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: Group A
High dose Monovalent Avian Influenza VLP (H7N9); IM; Day 0 & 21
|
|
Experimental: Group B
Intermediate dose Monovalent Avian Influenza VLP (H7N9); IM; Day 0 & 21
|
|
Experimental: Group C
Intermediate dose Monovalent Avian Influenza VLP (H7N9) and Low dose Adjuvant 1; IM; Day 0 & 21
|
|
Experimental: Group D
Low dose Monovalent Avian Influenza VLP (H7N9) and Low dose Adjuvant 1; IM; Day 0 & Day 21
|
|
Experimental: Group E
Intermediate dose Monovalent Avian Influenza VLP (H7N9) and High dose Adjuvant 1; IM; Day 0 & 21
|
|
Experimental: Group F
Low dose Monovalent Avian Influenza VLP (H7N9) and High dose Adjuvant 1; IM; Day 0 & 21
|
|
Experimental: Group G
Placebo; IM; Day 0 & 21
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Assessment of Safety
Periodo de tiempo: Day 0 to Day 384
|
Number (and percentages) of subjects with solicited local and systemic AEs over the seven days post-injection and all adverse events, solicited and unsolicited, including adverse changes in clinical laboratory parameters, over 35 days post-first injection. Significant New Medical Conditions, Medically Attended Events and Serious Adverse Events will be collected for one year post-second injection. |
Day 0 to Day 384
|
Immunogenicity as assessed by hemagglutination-inhibiting (HAI) antibody titers against the vaccine-homologous A/Anhui/1/13 (H7N9) virus.
Periodo de tiempo: Day 0 to Day 384
|
|
Day 0 to Day 384
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Inmunogenicidad evaluada por anticuerpos inhibidores de neuraminidasa contra N9.
Periodo de tiempo: Día 0 a Día 384
|
Día 0 a Día 384
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
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
- NVX900.PH7.101
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. .