Immune response to seasonal influenza vaccine MedDRA version: 20.0 Level: HLT Classification code 10022005 Term: Influenza viral infections System Organ Class: 100000004862 MedDRA version: 21.0 Level: LLT Classification code 10060063 Term: Influenza serology System Organ Class: 100000004848
Conditions
Interventions
Trade Name: BCG vaccine "AJ Vaccines"
Product Name: BCG Vaccine "AJ Vaccines"
Pharmaceutical Form: Concentrate and solvent for solution for injection
INN or Proposed INN: Bacillus Calmette-Guerin
Othe
Sponsors
University of Southern Denmark, Bandim Health Project
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;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: - Improve their general resistance towards infections - 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Infection rate for 5 months post-randomisation. Association between influenza antibody level and subsequent infection rate. Lymphocyte-dependent responses 7 days after influenza vaccination. Induction of innate immune memory 14- and 42-days post-randomisation. ;Timepoint(s) of evaluation of this end point: Infection rate during 5 months post-randomisation. Infection rate 6 months post-randomisation. Lymphocyte-dependent responses 7 days after influenza vaccination. The induction of innate immune memory 14 and 42 days post-radomisation. | — |
Countries
Denmark
Contacts
Public ContactChristine Stabell Benn
Bandim Health Project
Outcome results
None listed