Evaluation of Clinical and Antibody Response to Covid-19 Vaccination Strategy in TBRI, Egypt
Descripción general del estudio
Descripción detallada
SARS-CoV-2 has been in the human population for more than a year now, causing severe disease in some and resulting in a pandemic that continues to put severe strain on economies and healthcare infrastructures worldwide. Vaccination is considered as one of the greatest successes in medical history. Based on prior experience with the development of SARS-CoV vaccines, all COVID-19 vaccines must be subjected to the tests for protective effects and harmful risks derived from antibody-dependent enhancement that may contribute to augmented infectivity and/or eosinophilic infiltration. The SARS-CoV-2 vaccine is now being developed urgently in several different ways.
In the UK, the first three vaccines have emergency use authorization, and a national rollout is in progress. Many other countries are also instigating large scale vaccination programmes. Assessment of the safety and efficacy of vaccines against the severe acute respiratory syndrome coronavirus (SARS-CoV-2) in different populations is essential .
The UK government recently decided to extend the interval between the first dose of the Pfizer BioNTech and AstraZeneca COVID-19 vaccines from 3 weeks to 12 weeks to maximise the number of people receiving the initial dose, despite the trials only providing vaccine efficacy data based on a schedule of 21 days between doses.
Many reports were raised claiming Astrazenica vaccine for the development of vascular thrombosis and studies are not finalized regarding this issue .
China is regarded as one of the world's leading countries in SARS-CoV-2 vaccine development, up to date the last inactivated vaccine international clinical (Phase III) trial was launched in the United Arab Emirates by Sinopharm China National Biotec Group (CNBG).The ability to track and trace vaccines through the vaccine supply chain down to persons vaccinated has to be enhanced.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Giza, Egipto
- Reclutamiento
- Samia El-Shishtawy
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Contacto:
- Samia H El-Shishtawy, Assi. prof
- Número de teléfono: 01003661563
- Correo electrónico: crc.tbri@gmai.com
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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:
- All male and female above 18 years
Exclusion Criteria:
- age below 18 years -pregnancy-
- fever
- IGM positive for covid 19
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Poner en pantalla
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Otro: 1- Before vaccination:
To detect:
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COVID-19 vaccines should be administered by intramuscular (IM) injection, preferably into the deltoid muscle of the upper arm.
Individuals who have minimal muscle mass in the deltoid area of the upper arm, or a particular reason to avoid immunization in the deltoid muscle, can be given their vaccine in the vastuslateralis muscle in the thigh if necessary.
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Otro: 2-7 days after the first dose
Measuring D-dimer
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COVID-19 vaccines should be administered by intramuscular (IM) injection, preferably into the deltoid muscle of the upper arm.
Individuals who have minimal muscle mass in the deltoid area of the upper arm, or a particular reason to avoid immunization in the deltoid muscle, can be given their vaccine in the vastuslateralis muscle in the thigh if necessary.
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Otro: 3-Before the second dose:
To detect IgG and IgM To detect the level of Covid-19 Ig G antibodies titer in the blood, Quantitative Ig G titer should be measured.
To detect the response of the immune system to the vaccine.
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COVID-19 vaccines should be administered by intramuscular (IM) injection, preferably into the deltoid muscle of the upper arm.
Individuals who have minimal muscle mass in the deltoid area of the upper arm, or a particular reason to avoid immunization in the deltoid muscle, can be given their vaccine in the vastuslateralis muscle in the thigh if necessary.
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Otro: 4-After 3 months from the second dose:
To detect the level ofCovid-19 Ig G antibodies titer in the blood, Quantitative Ig G titer should be measured.
To detect the response of the immune system to the vaccine.
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COVID-19 vaccines should be administered by intramuscular (IM) injection, preferably into the deltoid muscle of the upper arm.
Individuals who have minimal muscle mass in the deltoid area of the upper arm, or a particular reason to avoid immunization in the deltoid muscle, can be given their vaccine in the vastuslateralis muscle in the thigh if necessary.
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Otro: 5-After 6 months from the second dose:
To detect the level ofCovid 19 Ig G antibodies titer in the blood, Quantitative Ig G titer should be measured.
To detect the response of the immune system to the vaccine.
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COVID-19 vaccines should be administered by intramuscular (IM) injection, preferably into the deltoid muscle of the upper arm.
Individuals who have minimal muscle mass in the deltoid area of the upper arm, or a particular reason to avoid immunization in the deltoid muscle, can be given their vaccine in the vastuslateralis muscle in the thigh if necessary.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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to develop IgG antibody
Periodo de tiempo: seven to ten days
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These antibodies indicate that you may have had COVID 19 in the recent past and have developed antibodies that may protect you from future infection.
It is unknown at this point how much protectionantibodies might provide against reinfection.
This group of individuals should receive the vaccine.
Quantitative Ig G titer should be measured.
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seven to ten days
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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
Otros números de identificación del estudio
- 00022021
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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