IMMUNE RESPONSE INDUCED BY VACCINATION WITH BCG

• Conditions: local pain, irritation or discomfort at the injection site (immediately after the injection)=commonuncommon= headache, fever local; enlargement of regional lymph node >1cm. Ulceration with a severe discharging ulcer at the site of injection.Rare: disseminated BCG complications such as osteitis or osteomyelitis, allergic reactions, including anaphylactic reactions. Local suppurative lymphadenitis, abscess formation.

• Registration Number: NL-OMON29225
• Lead Sponsor: Performer; University Medical Center

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Other
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

HEALTHY

AGE 18-55 YEAR

Exclusion Criteria

HISTORY OF TB DISEASE OR TREATMENT

BCG VACCINATION

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
to characterize the anti-mycobacterial immune responses during vaccination with live-attenuated M. bovis BCG Danish strian 1331, in order to provide a framework for using biomarkers in future TB vaccine trials.

Secondary Outcome Measures

Name	Time	Method
to evaluate whether biomarkers, specific for BCG can be detected in the circulation and in the urine following vaccination.