Corona COVID-19
Conditions
Interventions
One group has been vaccinated with BCG in the past 12 months and will be
vaccinated with the COVID-19 vaccine from Pfizer/BioNTech. The other group has
never been vaccinated with BCG and will be vac
Sponsors
Interne Geneeskunde
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age equal to or above 18 years; - Written informed consent provided by the participant; - Receiving BioNTech/Pfizer COVID-19 vaccine per routine care; - Having received BCG-vaccination in the past 12 months OR never having received BCG-vaccination.
Exclusion criteria
Exclusion criteria: - Legally incapacitated or unwilling to provide informed consent; - History of COVID-19 infection, confirmed by a microbiological test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serological titer of IgG to the SARS-CoV-2 spike protein at 6 and 12 months after the Pfizer/BioNTech BNT162B2 vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Geometric mean concentrations (GMCs) of RBD- and S-specific IgG, IgA and IgM in serum at day 35 after the first dose of the Pfizer/BioNTech BNT162B2 vaccination; - IgG, IgA and IgM concentrations against SARS-CoV-2 antigens in nasal mucosal lining fluid at the various sampling time points. - Local reactions at injection site or systemic reactions after COVID-19 vaccination. - T-cell responses and monocyte cytokine response to ex vivo stimulation at the various time points. | — |
Countries
Netherlands
Outcome results
None listed