Het onderzoek wordt bij gezonde mensen uitgevoerd. Uitkomsten uit deze lijn van onderzoek bieden nieuwe handvatten voor verklaringsmodellen en therapeutische interventies voor gezonde mensen en patiënten met inflammatoire aandoeningen waarbij een verandering in de inflammatoire respons optreedt. not applicable
Conditions
Interventions
The experimental group will receive a psychological training directed at
optimizing immune function in healthy male subjects.
Sponsors
Universiteit Leiden
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Healthy male adult volunteers between 18 and 35 years of age. Good understanding of written and spoken Dutch. Naive for tuberculosis.
Exclusion criteria
Exclusion criteria: History of inflammatory or cardiovascular diseases Known hypersensitivity or allergy to any of the vaccine components History exposure to open TB, (latent) TB disease or treatment BCG vaccination at any time prior to entering the trial Live vaccination (measles, mumps, rubella, oral polio, oral typhoid, varicella or yellow fever) 4 weeks or less prior to the BCG vaccination Treatment with immune modulating drugs (systemic steroids, azathioprine, cyclosporine, anti-TNFa, immunoglobulines, cytostatics) 3 months or less prior to enrolment (History of) disease affecting the lymphoid organs (Hodgkin*s disease, lymphoma, leukaemia, sarcoidosis) Known congenital or acquired immune deficiencies (e.g. HIV) Psychiatric (DSM-V) or somatic conditions that interfere with the participant's safety and/or the study protocol (assessed during screening) such as personality disorders, schizophrenia, or haemophilia. Professional sport player or extreme exercise (assessed during screening) Excessive drinking or drug use Active participation in other clinical trials Not giving consent to inform the participant*s General Practicioner of the BCG vaccination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study outcome is vitality measured by the composite of the Subjective Vitality Scale and the Checklist Individual Strength after the psychological expectancy training at 6 weeks compared to baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcomes are assessed: 1) Vitality and well-being at the day of vaccination, at the test day 1 day after vaccination (10 weeks after the start of the study), and at the follow up session (14 weeks after the start of the study). 2) Inflammatory responses (e.g., CRP, IL-6, TNF-*) measured in blood at five time points (at screening, the day of vaccination, twice (start and end of day) at the test day 1 day after vaccination (10 weeks after the start of the study), and at the follow up session (14 weeks after the start of the study). 3) LPS stimulated blood at screening, at the day of vaccination and at the start of the test day 1 day after vaccination. 4) Salivary physiological responses (e.g., cortisol, alpha amylase) measured at the same time points as the blood samples and additionally after each stress task 1 day after vaccination (10 weeks after the start of the study). 5) Psychological well-being assessed by NRS scores 1 day after vaccination (at the start of the test day and after each stress task) and assessed by positive and negative mood measured at the same time points as the blood samples. 6) Performance on stress tasks (Paced Auditory Serial Addition Task, Cold Pressor Test, Trier Social Stress Test) assessed at the test day 1 day after vaccination. 7) Heart rate, heart rate variability and skin conductance are sampled during screening and during the test day 1 day after vaccination (10 weeks after the start of the study) and finally during follow up. Demographic variables, self-reported measures of e.g., personality characteristics and the 5-HTTLPR genotypes and other candidate genotypes will be assessed as possible predictors of vitality and inflammatory responses. | — |
Countries
Netherlands
Outcome results
None listed