The effects of BCG-vaccination on the immune response induced by influenza-vaccination in healthy volunteers. A pilot proof-of-principle study.

Phase 2

Completed

Conditions: Influenza infection
the flu
10021460
10047438

Registration Number: NL-OMON40818

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 72

Inclusion Criteria

- Age >=18 and <=35 yrs or >=65 yrs
- Male
- Healthy

Exclusion Criteria

- Prior exposure to *Influvac* influenza virus strains , measured by antibody titres. Previous exposure is defined by antibody titres >=1:40.
- History of influenza vaccination within the year prior to study entry
- History of BCG vaccination within 5 years prior to study entry
- History of Mantoux testing within the year prior to study entry
- Vaccination other than BCG or influenza, within 3 months prior to study or within study period
- Medical history of any disease associated with immune deficiency
- Clinically significant acute illness, including infections, within 4 weeks before vaccination
- Participation in a drug trial or donation of blood 3 months prior to study entry
- Use of recreational drugs within 21 days prior to experiment day
- Recent hospital admission or surgery with general anaesthesia (<3 months)
- Known chronic kidney or liver disease
- Latent or active tuberculosis infection

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study endpoint is the difference in influenza antibody titres 2 and<br /><br>4 weeks (±2 days) after influenza vaccination between BCG-vaccinated subjects<br /><br>and subjects in the control group.</p><br>

Secondary Outcome Measures