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

Sponsor

Lead Sponsor: Mebo Research, Inc.

Collaboratore: Aurametrix

Fonte Mebo Research, Inc.
Breve riassunto

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.

Descrizione dettagliata

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.

Stato generale Not yet recruiting
Data d'inizio 2021-05-01
Data di completamento 2022-12-31
Data di completamento principale 2022-05-15
Tipo di studio Observational
Il risultato principale
Misurare Lasso di tempo
Adverse reactions/events 10 days post-doses 1 and 2
Esito secondario
Misurare Lasso di tempo
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
Iscrizione 1000
Condizione
Intervento

Tipo di intervento: Biological

Nome intervento: COVID-19 vaccine

Descrizione: Emergency-use authorized COVID-19 vaccine

Eleggibilità

Metodo di campionamento: Probability Sample

Criteri:

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.

Genere: All

Età minima: 16 Years

Età massima: N/A

Volontari sani: Accepts Healthy Volunteers

Ufficiale generale
Cognome Ruolo Affiliazione
Irene Gabashvili, PhD Principal Investigator Mebo Research, Inc.
Contatto generale

Cognome: Maria de la Torre

Telefono: (786) 228-6880

E-mail: [email protected]

Posizione
Servizio, struttura: Contatto: Contatta il backup:
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]
Paesi di posizione

United Kingdom

United States

Data di verifica

2021-04-01

Parte responsabile

Genere: Sponsor

parole
Ha accesso esteso No
Braccio di gruppo

Etichetta: 75 years of age or older

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

Etichetta: 65-74 years of age

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

Etichetta: 16-64 years of age

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

Etichetta: MEBO/PATM

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

Dati del paziente No
Informazioni sul design dello studio

Modello osservazionale: Other

Prospettiva temporale: Prospective

Fonte: ClinicalTrials.gov

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