No registrations found.
ID
Source
Brief title
Health condition
COVID-19, SARS-CoV-2
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
Epigenetic and metabolic changes in monocytes between the aforementioned treatment groups
Background summary
Rationale: 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.
Objective: To investigate the effect of bisphosphonates and the MMR vaccine on BCG-induced trained immunity.
Study design: Explorative randomized controlled trial.
Study population: Healthy volunteers aged 18-50 years old.
Intervention (if applicable): The intervention groups are as follows:
1. Placebo treatment
2. BCG vaccination
3. BCG vaccination + oral bisphosphonate supplementation (alendronic acid)
4. BCG vaccination + MMR vaccine
5. MMR vaccine alone
Main study parameters/endpoints: The main study parameter is the fold-increase in production of pro-inflammatory cytokines by PBMCs/monocytes following vaccination.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: 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.
Study objective
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.
Study design
0, 28 days
Intervention
1. Placebo treatment
2. BCG vaccination
3. BCG vaccination + oral bisphosphonate supplementation (alendronic acid)
4. BCG vaccination + MMR vaccine
5. MMR vaccine alone
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
IPD sharing statement
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 |
|---|---|
| NTR-new | NL8609 |
| Other | METC Arnhem-Nijmegen : 2020-6564 |