Strengthening the protection against influenza in the elderly

Phase 1

• Conditions: Immune response to seasonal influenza vaccine; MedDRA version: 20.0Level: HLTClassification code 10022005Term: Influenza viral infectionsSystem Organ Class: 100000004862; MedDRA version: 21.0Level: LLTClassification code 10060063Term: Influenza serologySystem Organ Class: 100000004848; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2019-002781-12-DK
• Lead Sponsor: niversity of Southern Denmark, Bandim Health Project

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-25
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Elderly people > 65 years and eligible for seasonal influenza vaccination. Participants must have access to ‘e-Boks’.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

Exclusion Criteria

•Known allergy to (components of) the BCG vaccine or serious adverse events in relation to prior BCG administration
•Previous Mycobacterium tuberculosis (M. tuberculosis) infection or known active or latent infection with M. tuberculosis or other mycobacterial species
•Fever (>38 C) within the past 24 hours or suspicion of active viral or bacterial infection
•Vaccination with other live attenuated vaccine within the last 4 weeks
•Severely immunocompromised subjects. This exclusion category comprises:
•Subjects with known infection with the human immunodeficiency virus (HIV)
•Subjects with solid organ transplantation or bone marrow transplantation
•Subjects under chemotherapy
•Subjects with primary immunodeficiency
•Treatment with any anti-cytokine therapy within the last year
•Treatment with oral or intravenous steroids defined as daily doses of 10 mg prednisone or equivalent for longer than 3 months
•Active solid or non-solid malignancy or lymphoma within the prior two years
•Subjects who do not have access to e-Boks.
•Participant in BCG-DENMARK-SENIOR study

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: We will test the effect of BCG vaccine on the specific immune response to seasonal influenza vaccination in elderly people>65 years, with the aim to improve the specific antibody response to the vaccination. <br><br>;Secondary Objective: We will test the effect of BCG vaccine on the immune system and health in general in elderly people>65 years, with the aim to: <br>- Improve their general resistance towards infections <br>- Study the effect of BCG on classical lymphocyte-dependent responses, and the induction of innate immune memory.;Primary end point(s): The main outcome will be change in antibody levels to influenza virus strains, comparing levels just before and 4 weeks after influenza vaccination. ;Timepoint(s) of evaluation of this end point: 4 weeks post-influenza vaccination

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Infection rate for 5 months post-randomisation. <br>Association between influenza antibody level and subsequent infection rate.<br>Lymphocyte-dependent responses 7 days after influenza vaccination.<br>Induction of innate immune memory 14- and 42-days post-randomisation.<br>;Timepoint(s) of evaluation of this end point: Infection rate during 5 months post-randomisation.<br>Infection rate 6 months post-randomisation.<br>Lymphocyte-dependent responses 7 days after influenza vaccination.<br>The induction of innate immune memory 14 and 42 days post-radomisation.