A Phase 2/3 interventional study of Placebo and BCG in Influenza Virus Infection and Trained Immunity, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Open to male participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-11-10.
Sponsored by Radboud University Medical Center · Phase 2/3, Interventional, and Prevention
In the present study, the investigators want to investigate whether prior BCG-vaccination improves the efficacy of influenza ("the flu") vaccination in young and/or old healthy volunteers and consequently could protect against influenza virus infection.
Influenza virus infection leads to millions of cases of severe illnesses worldwide and up to an estimated 500.000 deaths annually. The potential for the sudden emergence of pandemic influenza strains represents an incessant threat on even a larger scale. seasonal influenza vaccination is the backbone of influenza management. However, antibodies generated by vaccination, most often do not effectively neutralize emergent strains due to the high mutation rate of the influenza viral genome. In addition, although vaccination is effective in up to 85% of healthy adults, only 40-60% of the elderly are able to mount an protective antibody response due to an agerelated decline in immune function (so-called immunoscenescence). As a result, the protective effects of influenza vaccination are limited, and strategies to improve host immune defenses against influenza virus infection per se, and following influenza vaccination, are highly warranted.
It is suggested that prior vaccination with Bacille Calmette-Guérin (BCG) could enhance resistance to other infectious diseases in addition to protection to tuberculosis (TBC) and, in mice, protection of prior BCGvaccination against influenza infection was demonstrated long ago. However, only recently substantial evidence for these nonspecific beneficial effects of BCG-vaccination in humans has been provided by several randomized clinical trials. Considering these potentiating effects of BCG-vaccination, it could be a viable strategy to improve efficacy of influenza vaccination, and/or enhance immune defenses against influenza virus infection per se. If so, this would have an enormous impact on clinical practice.
2,214 studies on the registry are indexed under Influenza, Human; 164 are open to participants now.
This study's enrollment of 40 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
BCG vaccination
Biological: BCG
administration of NaCl 0.9%.
Other: Placebo
Administration of 0.9% NaCl.
Vaccination with the live attenuated BCG vaccine.
Difference in influenza antibody titres between BCG-vaccinated subjects and subjects in the control group
Time frame: Day 14, day 21, day 28, day 42 (±2 days)
Difference in Thrombocyte function between BCG-vaccinated subjects and subjects in the control group
Time frame: Day 0, day 14, day 21, day 28, day 42 (±2 days)
Proportion of participants in each group who achieved seroprotection (defined by antibody titre ≥1:40).
Time frame: day 21, day 28, day 42 (±2 days)
Proportion of participants in each group who achieved seroconversion (defined by a ≥4-fold rise in antibody titre).
Time frame: day 21, day 28, day 42 (±2 days)
IFN-gamma/IL-10 production of leukocytes ex vivo stimulated with inactivated/live influenza virus (0.1ug HA/ml).
Time frame: Day 0, day 14, day 28, day 42 (±2 days)
Production of Type 1 IFNs, IL-17 and IL-22 by leukocytes ex vivo stimulated with inactivated/live influenza virus (0.1ug HA/ml).
Time frame: Day 0, day 14, day 28, day 42 (±2 days)
Production of other inflammatory mediators (including TNFα, IL-1β, IFN-gamma, IL-10, IL-17, IL-22) by leukocytes ex vivo stimulated with different not-related stimuli (including m. tuberculosis, s. aureus, c. albicans, and inactivated influenza).
Time frame: Day 0, day 21, day 28, day 42 (±2 days)
Inflammatory transcriptional pathways (by use of qPCR/microarrays) .
Time frame: Day 0, day 14, day 28, day 42 (±2 days)
Granzyme B production of leukocytes ex vivo stimulated with inactivated/live influenza virus (0.1ug HA/ml).
Time frame: Day 0, day 14, day 28, day 42 (±2 days)
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Radboud University Medical Center