Enhancing the BCG-induced trained immunity response by addition of bisphosphonate or MMR vaccine: a possible preventive approach against COVID-19 (BCG-PLUS)

Completed

• Conditions: innate immune memory; trained immunity; 10027665; 10002252

• Registration Number: NL-OMON49014
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• 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
<p>The main study parameter is the fold-increase in production of pro-inflammatory<br /><br>cytokines by PBMCs/monocytes following vaccination.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Metabolic changes and epigenetic profiles</p><br>