The COVID-19 Back-to-Normal Study

A Phenotypic Study of Safety, Tolerability, Reactogenicity, Immunogenicity, and Virus Shedding Potential of Emergency-Use-Authorized Vaccines Against COVID-19

Patrocinadores

Patrocinador principal: Mebo Research, Inc.

Colaborador: Aurametrix

Fuente Mebo Research, Inc.
Resumen breve

During the study, members of different neighborhood and digital communities will be followed post COVID-19 vaccination. Injection-site (local) and systemic reaction data will be assessed on vaccination day and afterwards using either web surveys or personal communication, depending on study participant preference. Hypothesis to be tested The safety profile and the magnitude and durability of immune responses to the COVID-19 vaccines as well as adverse reactions depend on health conditions, metabolism and microbiomes.

Descripción detallada

The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was declared a Public Health Emergency of International Concern in January 2020 and upgraded to pandemic in March 2020. First vaccines to prevent COVID-19 were authorized for emergency use in the US in December 2020, but a number of unknowns still remains. One of these unknowns is the relationship of the microbiota, gut dysbiosis and impaired metabolism with active immunity to pathogens and vaccines and tolerance to antigens. Study groups will be based on age, metabolism and self-reported symptoms. Data will be collected continuously via surveys and investigator-participant interactions, as needed. Statistical methods used will be the ones with the greatest power.

Estado general Not yet recruiting
Fecha de inicio 2021-05-01
Fecha de Terminación 2022-12-31
Fecha de finalización primaria 2022-05-15
Tipo de estudio Observational
Resultado primario
Medida Periodo de tiempo
Adverse reactions/events 10 days post-doses 1 and 2
Resultado secundario
Medida Periodo de tiempo
Long-term adverse events Throughout the study period, until 12 months post-final-dose
Percentage of participants with COVID-19 Disease From 14 days after completion of the 2-dose regimen up to 12 months post-final-dose
Inscripción 1000
Condición
Intervención

Tipo de intervención: Biological

Nombre de intervención: COVID-19 vaccine

Descripción: Emergency-use authorized COVID-19 vaccine

Elegibilidad

Método de muestreo: Probability Sample

Criterios:

Inclusion Criteria: - Individuals 16 or older at the time of consent - Intention to vaccinate and of being available for entire study period Exclusion Criteria: - Any illness or condition that in the opinion of the investigator may affect the safety of the participant or the evaluation of any study endpoint.

Género: All

Edad mínima: 16 Years

Edad máxima: N/A

Voluntarios Saludables: Accepts Healthy Volunteers

Oficial general
Apellido Papel Afiliación
Irene Gabashvili, PhD Principal Investigator Mebo Research, Inc.
Contacto general

Apellido: Maria de la Torre

Teléfono: (786) 228-6880

Email: [email protected]

Ubicación
Instalaciones: Contacto: Copia de seguridad de contactos:
MEBO Research, Inc | Miami, Florida, 33175, United States Maria de la Torre 786-228-6880 [email protected]
Kahite | Vonore, Tennessee, 37885, United States Irene G Allsup, PhD 408-341-9355 [email protected]
Mary Washington Hospital Research | Fredericksburg, Virginia, 22401, United States Christine Emery, BSN, RN 540-741-4708 [email protected]
Mebo Research (Uk) | London, England, W10 5LE, United Kingdom Cole Flaherty [email protected]
Ubicacion Paises

United Kingdom

United States

Fecha de verificación

2021-04-01

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Grupo de brazo

Etiqueta: 75 years of age or older

Descripción: individuals 75 years of age and older who received COVID-19 vaccine

Etiqueta: 65-74 years of age

Descripción: individuals 65-74 years of age who received COVID-19 vaccine

Etiqueta: 16-64 years of age

Descripción: Individuals in 16-64 age range who received COVID-19 vaccine

Etiqueta: MEBO/PATM

Descripción: Individuals in 16-69 age range with present or past MEBO/PATM symptoms who received COVID-19 vaccine

Datos del paciente No
Información de diseño del estudio

Modelo de observación: Other

Perspectiva de tiempo: Prospective

Fuente: ClinicalTrials.gov

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