Impact of BCG vaccination, originally made to prevent tuberculosis, on the immune response to the COVID-19 vaccine in health care workers
Phase 1
- Conditions
- Immunogenicity of the mRNA BNT162b2 COVID-19 vaccine.Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2021-000182-33-NL
- Lead Sponsor
- Radboudumc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 40
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- Legally incapacitated or unwilling to provide informed consent;
- History of COVID-19 infection, confirmed by a microbiological test.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main objective is to analyze whether BCG-vaccination prior to COVID-19 vaccination can enhance the immunogenicity of the COVID-19 mRNA vaccine developed by BioNTech and Pfizer.;Secondary Objective: Secondary objectives are to determine if antibody concentrations against SARS-CoV-2 antigens in nasal mucosal lining fluid at the various sampling time points can be detected and if prior BCG vaccination leads to more severe local or systemic reactions after COVID-19 vaccination.<br>;Primary end point(s): Seroconversion of IgG to the SARS-CoV-2 spike protein at day 21 after the first dose of Pfizer/BioNTech BNT162B2. Seroconversion of antibodies is defined as a change from seronegative at baseline (pre-1st dose of Pfizer/BioNTech BNT162B2) to seropositive or a =four-fold titer increase if the participant is seropositive at baseline;Timepoint(s) of evaluation of this end point: The primary endpoint will be analyzed when all blood samples of timepoint Day 21 have been collected.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Geometric mean concentrations (GMCs) of RBD- and S-specific IgG, IgA and IgM in serum at day 21, 35, month 6 and 12;<br>- IgG, IgA and IgM concentrations against SARS-CoV-2 antigens in nasal mucosal lining fluid at the various sampling time points;<br>- Local reactions at injection site or systemic reactions after COVID-19 vaccination;<br>- T-cell responses and monocyte cytokine response to ex vivo stimulation at the various time points.<br>;Timepoint(s) of evaluation of this end point: Secondary analyses will need data from follow-up of the study and will be performed at the end of the study.