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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27545

Enrollment

100

Registered

2020-05-11

Start date

2020-05-25

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

COVID-19, SARS-CoV-2

Interventions

1. Placebo treatment 2. BCG vaccination 3. BCG vaccination + oral bisphosphonate supplementation (alendronic acid) 4. BCG vaccination + MMR vaccine 5. MMR vaccine alone

Eligibility

Inclusion criteria

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

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.

Design outcomes

Secondary

Measure	Time frame
Epigenetic and metabolic changes in monocytes between the aforementioned treatment groups	—

Primary

Measure	Time frame
The main study parameter is the fold-increase in production of pro-inflammatory cytokines by PBMCs/monocytes following vaccination.	—

Contacts

Public ContactPriya Debisarun

Radboudumc

priya.debisarun@radboudumc.nl0243613889

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)