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…
ID
Bron
Verkorte titel
Aandoening
COVID-19, SARS-CoV-2
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The main study parameter is the fold-increase in production of pro-inflammatory cytokines by PBMCs/monocytes following vaccination.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
0, 28 days
Onderzoeksproduct en/of interventie
1. Placebo treatment
2. BCG vaccination
3. BCG vaccination + oral bisphosphonate supplementation (alendronic acid)
4. BCG vaccination + MMR vaccine
5. MMR vaccine alone
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• Adult (18-50 years of age);
• Male or female;
• Healthy;
• Written informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• 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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8609 |
| Ander register | METC Arnhem-Nijmegen : 2020-6564 |