To investigate the effect of bisphosphonates and the MMR vaccine on BCG-induced trained immunity as a possible preventive approach against COVID-19
ID
Source
Brief title
Condition
- Immune disorders NEC
- Ancillary infectious topics
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the fold-increase in production of pro-inflammatory
cytokines by PBMCs/monocytes following vaccination.
Secondary outcome
Metabolic changes and epigenetic profiles
Background summary
There is currently no specific treatment or vaccine for SARS-CoV-2. Induction
of trained immunity by BCG vaccination is a promising non-specific preventive
measure, but not all individuals respond equally strongly to it. It is
therefore important to maximize the protective potential of BCG. This study
will investigate the efficacy of bisphosphonates and the MMR vaccine to enhance
trained immunity responses to BCG vaccination in order to implement this as a
preventive strategy against COVID-19.
Study objective
To investigate the effect of bisphosphonates and the MMR vaccine on BCG-induced
trained immunity as a possible preventive approach against COVID-19
Study design
Explorative randomized controlled trial.
Intervention
1. Placebo treatment
2. BCG vaccination
3. BCG vaccination + oral bisphosphonate supplementation (alendronic acid)
4. BCG vaccination + MMR vaccine
5. MMR vaccine alone
Study burden and risks
The expected risk of participation is very low. All vaccines and treatments are
approved medications and no adverse interactions are expected. BCG can
interfere with standard tuberculin skin test for tuberculosis, but an
alternative is available (quantiferon). The participants will visit the
outpatient clinic twice for blood donations. They will undergo no other
invasive procedures for study purposes.
Geert Grooteplein 8
Nijmegen 6525 GA
NL
Geert Grooteplein 8
Nijmegen 6525 GA
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2020-002456-21-NL |
| CCMO | NL74082.091.20 |