Enhancing the BCG-induced trained immunity response by addition of bisphosphonate or MMR vaccine: a possible preventive approach against COVID-19 (BCG-PLUS)
- Conditions
- COVID-19, SARS-CoV-2
- Registration Number
- NL-OMON27545
- Lead Sponsor
- Radboudumc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
•Adult (18-50 years of age);
•Male or female;
•Healthy;
•Written informed consent
Exclusion Criteria
•Known allergy to (components of), or any other contraindication to, the BCG vaccine, MMR vaccine, or alendronic acid.
•Known (history of) active or latent Mycobacterium tuberculosis or with another mycobacterial species;
•Prior BCG vaccination;
•Acute illness 2 weeks prior to the study or (suspicion of) active infection;
•Pregnancy;
•Chronic use of any systemic drugs other than oral contraceptives;
•Use of NSAIDs less than 4 weeks prior to start of the study;
•Vaccination in the past 3 months or expected vaccination during the study period, independent of the type of vaccination;
•Medical history associated with immunodeficiency.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main study parameter is the fold-increase in production of pro-inflammatory cytokines by PBMCs/monocytes following vaccination.
- Secondary Outcome Measures
Name Time Method Epigenetic and metabolic changes in monocytes between the aforementioned treatment groups