Resumen

Este estudio es un ensayo clínico de fase III, multicéntrico global, aleatorizado, doble ciego, controlado con placebo, con diseño adaptativo, con el fin de evaluar la eficacia, seguridad e inmunogenicidad de la Vacuna Recombinante contra el Nuevo Coronavirus (Vector de Adenovirus Tipo 5) en adultos de 18 años de edad y mayores.

Descripción detallada

Este es un ensayo clínico global de fase III para evaluar la eficacia, seguridad e inmunogenicidad de Ad5-nCoV fabricada por CanSino y el Instituto de Biotecnología de Beijing en adultos sanos de 18 años de edad y mayores. El estudio será un ensayo doble ciego, controlado con placebo, con participantes asignados aleatoriamente en proporción 1:1 a las cohortes de placebo y vacuna experimental. El esquema de inmunización es una dosis de inyección intramuscular (deltoides).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Adults of 18 years old and above.
Participants who are at high risk of SARS-CoV-2 infection.
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/personal doctor and access all medical records when relevant to study procedures.
Agreement to refrain from blood donation during the study.
provide written informed consent.

Criterios de exclusión

Participation in any other COVID-19 prophylactic drug trials for the duration of the study.
Participation in SARS-CoV-2 serological surveys where participants are informed of their serostatus for the duration of the study.
Planned receipt of any vaccine (licensed or investigational), other than the study intervention, within 14 days before and after study vaccination.
Prior receipt of an investigational or licensed vaccine likely to impact on the interpretation of the trial data.
Administration of immunoglobulins and/or any blood products within the three months prior to the planned administration of the vaccine candidate.
Planned receipt of any vaccine (licensed or investigational), other than the study intervention, within 14 days before and after study vaccination
Prior receipt of an investigational or licensed vaccine likely to impact on the interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus or SARS vaccines)
Administration of immunoglobulins and/or any blood products within the three months prior to the planned administration of the vaccine candidate
Any confirmed or suspected immunosuppressive or immunodeficient state; positive HIV status; asplenia; recurrent severe infections and chronic use.
History of allergic disease or reactions likely to be exacerbated by any component of Ad5-nCoV
Any history of angioedema
Any history of anaphylaxis to any vaccine component
Pregnancy, lactation or willingness/intention to become pregnant during the study
Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
History of serious psychiatric condition likely to affect participation in the study
Suspected or known current alcohol or drug dependency
Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness
History of laboratory-confirmed COVID-19
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.

Ubicaciones

Fundación Socolinsky Centro de Vacunación Proteger - Recoleta

CABA, Buenos Aires, Argentina

Hospital Pirovano

CABA, Buenos Aires, Argentina

Htal de Alta Complejidad Cuenca Alta Néstor Kirchner

Cañuelas, Buenos Aires, Argentina

Hospital Interzonal de Agudos "San Juan de Dios" de La Plata

La Plata, Buenos Aires, Argentina

Hospital Rossi

La Plata, Buenos Aires, Argentina

Inst. Médico Platense

La Plata, Buenos Aires, Argentina

Instituto de Investigaciones Clínicas

Mar del Plata, Buenos Aires, Argentina

Htal Mariano y Luciano de la Vega

Moreno, Buenos Aires, Argentina

Hospital Houssay

Vicente López, Buenos Aires, Argentina

Hospital Zonal General de Agudos "Cetrangolo"

Vicente López, Buenos Aires, Argentina

Instituto Cer

Vicente López, Quilmes, Argentina

Previvax Centro de Vacunación

Córdoba, Argentina

Ensayo clínico de fase III, multicéntrico global, aleatorizado, doble ciego, controlado con placebo, con diseño adaptativo, para evaluar la eficacia, seguridad e inmunogenicidad de Ad5-nCoV en adultos de 18 años de edad y mayores

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

Placebo

Ubicaciones

Fundación Socolinsky Centro de Vacunación Proteger - Recoleta

Hospital Pirovano

Htal de Alta Complejidad Cuenca Alta Néstor Kirchner

Hospital Interzonal de Agudos "San Juan de Dios" de La Plata

Hospital Rossi

Inst. Médico Platense

Instituto de Investigaciones Clínicas

Htal Mariano y Luciano de la Vega

Hospital Houssay

Hospital Zonal General de Agudos "Cetrangolo"

Instituto Cer

Previvax Centro de Vacunación

Patrocinadores