The effects of BCG-vaccination on the immune response in healthy volunteers

Phase 1

• Conditions: sepsis induced immunoparalysis; MedDRA version: 16.1Level: PTClassification code 10040047Term: SepsisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2013-005520-42-NL
• Lead Sponsor: Radboud University Nijmegen Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-13
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 36

Inclusion Criteria

- Written informed consent
- Age =18 and =35 yrs
- Male
- Healthy

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Use of any medication
- History of BCG-vaccination
- Vaccination other than BCG, within 3 months prior to study or within study period
- Smoking
- Previous spontaneous vagal collapse
- History of atrial or ventricular arrhythmia
- (Family) history of myocardial infarction or stroke under the age of 65 years
- Cardiac conduction abnormalities on the ECG consisting of a 2nd degree atrioventricular block or a complex bundle branch block
- Hypertension (defined as RR systolic > 160 or RR diastolic > 90)
- Hypotension (defined as RR systolic < 100 or RR diastolic < 50)
- Renal impairment (defined as plasma creatinin >120 µmol/l)
- Liver enzyme abnormalities or positive hepatitis serology
- Medical history of any disease associated with immune deficiency
- CRP > 20 mg/L, WBC > 12x109/L, or clinically significant acute illness, including infections, within 4 weeks before endotoxin administration
- Participation in a drug trial or donation of blood 3 months prior to the LPS challenge
- Use of recreational drugs within 21 days prior to experiment day
- Recent hospital admission or surgery with general anaesthesia (<3 months)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified