Boosting the BCG-induced immunity response by addition of bisphosphonate or MMR vaccine: a possible preventive approach against the coronavirus (BCG-PLUS)

Phase 1

• Conditions: Trained immunityCOVID-19This study will investigate whether oral bisphosphonate supplementation or the MMR vaccine can be used as immune potentiators when simultaneously administered with BCG, to further amplify the BCG-induced trained immunity response and maximize potential protective effects against COVID-19.; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2020-002456-21-NL
• Lead Sponsor: Radboudumc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-26
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

•Adult (18-50 years of age);
•Male or female;
•Healthy;
•Written informed consent

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 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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;
•Active solid or non- solid malignancy within the prior two years;
•Hypocalcemia;
•Inability to sit upright for 30 minutes;
•Esophagus abnormalities

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified