Effect of Bacillus Calmette-Guérin vaccination on the immunogenicity of the mRNA BNT162b2 COVID-19 vaccine in health care workers

Phase 4

Completed

• Conditions: Corona; COVID-19; 10047438; 10024970

• Registration Number: NL-OMON50881
• Lead Sponsor: Interne Geneeskunde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

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

- Legally incapacitated or unwilling to provide informed consent;
- History of COVID-19 infection, confirmed by a microbiological test.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Serological titer of IgG to the SARS-CoV-2 spike protein at 6 and 12 months<br /><br>after the Pfizer/BioNTech BNT162B2 vaccination.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Geometric mean concentrations (GMCs) of RBD- and S-specific IgG, IgA and IgM<br /><br>in serum at day 35 after the first dose of the Pfizer/BioNTech BNT162B2<br /><br>vaccination;<br /><br>- IgG, IgA and IgM concentrations against SARS-CoV-2 antigens in nasal mucosal<br /><br>lining fluid at the various sampling time points.<br /><br>- Local reactions at injection site or systemic reactions after COVID-19<br /><br>vaccination.<br /><br>- T-cell responses and monocyte cytokine response to ex vivo stimulation at the<br /><br>various time points.</p><br>