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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002456-21-NL

Enrollment

100

Registered

2020-05-26

Start date

2020-05-28

Completion date

Unknown

Last updated

2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trained immunity COVID-19 This 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.

Interventions

Trade Name: BCG Vaccine AJV, powder and solvent for suspension for injection. Pharmaceutical Form: Concentrate and solvent for solution for injection/infusion Pharmaceutical form of the placebo: Solut

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effect of bisphosphonates and the MMR vaccine on BCG-induced trained immunity as a preventive approach against COVID-19;Secondary Objective: not apolicable;Primary end point(s): Induction of trained immunity as measured by the fold change (28 days after treatment relative to baseline) in cytokine production by peripheral blood monocytes upon stimulation with unrelated antigens.;Timepoint(s) of evaluation of this end point: at 28 days	—

Measure

Time frame

Main Objective: To investigate the effect of bisphosphonates and the MMR vaccine on BCG-induced trained immunity as a preventive approach against COVID-19;Secondary Objective: not apolicable;Primary end point(s): Induction of trained immunity as measured by the fold change (28 days after treatment relative to baseline) in cytokine production by peripheral blood monocytes upon stimulation with unrelated antigens.;Timepoint(s) of evaluation of this end point: at 28 days

—

Secondary

Measure	Time frame
Secondary end point(s): epigenetic and metabolic changes in monocytes between the aforementioned treatment groups;Timepoint(s) of evaluation of this end point: 28 days after inclusion	—

Countries

Netherlands

Contacts

Public ContactJaap ten Oever

Radboudumc

jaap.tenoever@radboudumc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026