Status:
COMPLETED
Efficacy and Tolerability of ABBC1 in Volunteers Receiving the Influenza or Covid-19 Vaccine
Lead Sponsor:
AB Biotek
Conditions:
Immunity
Vaccine Reaction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The immune system response needs to be forceful but also balanced for a rapid recovery from infection which avoids harmful overreactions. Innate immunity can adapt and respond more efficiently to seco...
Detailed Description
On March 11, 2020, the World Health Organization (WHO) declared the COVID-19 disease caused by SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) as a pandemic. The Covid-19 pandemic is evol...
Eligibility Criteria
Inclusion
- COMMON CRITERIA:
- Subjects with the ability to take the study product orally
- Ability to understand the study, the information about the symptoms and to comply with the treatment shots.
- Subject or legal guardian / representative willing to give informed consent in writing.
- INFLUENZA VACCINE GROUPS:
- Subjects who require hospitalization or external follow-up (outpatients or PADES)
- Subjects over 60 years old who will receive the influenza vaccine
- COVID-19 VACCINE GROUPS
- Subjects from long-stay centres attached to the Hospital Mare de Déu de la Mercè, and meet the following inclusion criteria:
- Groups:
- Subjects over 18 years of age who receive the Covid-19 vaccine, in a stable clinical situation, at the discretion of the researcher, or
- Healthcare workers of the study centers, over 18 years of age who receive the Covid-19 vaccine
- Availability to attend clinical visits.
Exclusion
- COMMON CRITERIA:
- Need for assisted ventilation that makes oral consumption of the product under study impossible
- History of allergy, idiosyncrasy, hypersensitivity or adverse reactions to the active principle or to any of the excipients.
- History or evidence of any medical conditions or medication use that, in the opinion of the principal investigator, could affect the safety of the subjects or interfere with the study evaluations
- Subjects in situation of last days
- COVID-19 VACCINE GROUPS:
- Subjects in whom the Covid-19 vaccine is contraindicated.
- A history of frailty or comorbidity that indicates a situation of clinical instability.
- History or evidence of any medical conditions or drug use that, in the opinion of the principal investigator, could affect the safety of subjects or interfere with study evaluations.
Key Trial Info
Start Date :
October 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 24 2021
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04798677
Start Date
October 29 2020
End Date
September 24 2021
Last Update
July 21 2022
Active Locations (1)
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1
Hospital Mare de Déu de la Mercè - Germanes Hospitalàries
Barcelona, Spain, 08042