Status:
COMPLETED
Modification of the COVID-19 Vaccine Response by an Intervention on the Intestinal Flora
Lead Sponsor:
Université de Sherbrooke
Collaborating Sponsors:
CHU de Quebec-Universite Laval
Conditions:
COVID-19
Vaccine Reaction
Eligibility:
All Genders
65-89 years
Phase:
NA
Brief Summary
The elderly, who are often in poorer health, have been particularly affected by the COVID-19 pandemic. Recent study results show that while vaccines have been very effective in the short term, protect...
Detailed Description
The elderly are at high risk of morbidity and mortality from COVID-19. They are particularly targeted by recent data: i) faster decline of the immune response in the elderly and ii) increase of COVID ...
Eligibility Criteria
Inclusion
- Men and women
- aged 65-89 years
- who have received 3 doses of a mRNA vaccine (Pfizer-BioNTech or Moderna) for more than 6 months;
- volunteered for a booster dose
- had telephone or internet access
- were able to provide informed consent
- lived \<75 km from the CRC (subgroup of 100 participants only)
Exclusion
- Patients with COVID-19 disease (clinical and serological data at post);
- with possibly affected cognitive functions (score \< 12 on the Functional Activities Questionnaire (FAQ))
- with allergies (soy, lactose, yeast, maltodextrin)
- with a chronically weakened immune system (AIDS...)
- undergoing anti-cancer treatment (chemotherapy or radiotherapy)
- who do not speak French or English.
Key Trial Info
Start Date :
November 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2024
Estimated Enrollment :
592 Patients enrolled
Trial Details
Trial ID
NCT05195151
Start Date
November 10 2022
End Date
July 17 2024
Last Update
January 15 2025
Active Locations (1)
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1
Centre de recherche clinique du CHUS
Sherbrooke, Quebec, Canada, J1H 5N4