One intradermal injection of 0.1ml of sodium chloride 0.9%

One intradermal injection of 0.1ml of BCG (BCG vaccine Bulgaria strain 1331; Intervax)

Infection

Hospitalization

Mortality

Patients discharged from hospital will be vaccinated with one intradermal injection of 0.1ml of BCG vaccine

Vaccination

Patients discharged from hospital will be vaccinated with one intradermal injection of 0.1ml of sodium chloride 0.9%

Placebo

4th Department of Internal Medicine, ATTIKON University Hospital

Bacillus Calmette-guérin Vaccination to Prevent Infections of the Elderly

A Randomized Clinical Trial for Enhanced Trained Immune Responses Through Bacillus Calmette-guérin Vaccination to Prevent Infections of the Elderly

The time interval to the first infection post hospital discharge between the two groups of treatment.

The rate of hospitalizations will be compared between the two groups of treatment

The time to first infection or sepsis episode will be compared between the two groups of treatment

The total number of infections will be compared between the two groups of treatment

The time to first hospitalization will be compared between the two groups of treatment

The number of antibiotic administrations will be compared between the two groups of treatment

Mortality will be compared between the two groups of treatment

Cytokine stimulation from peripheral blood monuclear cells will be compared between the two groups of treatment

Epigenetic changes of circulating monocytes will be compared between the two groups of treatment

The effect of BCG vaccination on cost of treatment for infections will be compared between the two groups of treatment

Hellenic Institute for the Study of Sepsis

Radboud University

A group of 20 healthy individuals without IBD, other chronic diseases, or immunosuppressive therapy will be enrolled. All healthy individuals will receive standard dose influenza vaccine SDIV.

A group of 20 patients who are currently on vedolizumab. All individuals in this group will receive SDIV

This arm will be a double blind randomized controlled trial of High dose influenza vaccine (HDIV) for IBD patients on TNF monotherapy.
40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.

This arm will be a double blind randomized controlled trial of standard dose influenza vaccine (SDIV) for IBD patients on TNF monotherapy.
40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.

Control Group

Vedolizumab Group

This arm will be a double blind randomized controlled trial of high dose influenza vaccine (HDIV) for IBD patients on TNF monotherapy.
40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.

High Dose Influenza Vaccine (HDIV)

Standard Dose Influenza Vaccine (SDIV)

Total

Sex: Female, Male

Race (NIH/OMB)

Region of Enrollment

Influenza vaccine antibody concentration will be measured in immunosuppressed IBD patients who receive high dose and standard of care dose influenza vaccine.
Higher antibody concentrations are associated with better protection from infection.

High Dose of Influenza Vaccine (HDIV) Group

Standard Dose Influenza Vaccine (SDIV) Group

Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine

Vaccine response rates for influenza vaccines in patients with inflammatory bowel disease will be accessed by number of patients who has shown significant seroconversion. Seroconversion is defined as a four fold increase in antibody concentration from preimmunization to 4 weeks post immunization.

High Dose of Influenza Vaccine(HDIV) Group

Contorl Group

Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion

Seroprotection is defined as an antibody concentration of at least 1:40 at 4 weeks post-immunization which confers protection from infection in about 50% of individuals

This arm will be a double blind randomized controlled trial of standard dose influenza vaccine (SDIV) for IBD patients on TNF monotherapy.
40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.
.

A group of 20 patients who are currently on Vedolizumab. All individuals in this group will receive SDIV

Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization

Seroprotection is defined by the FDA as post-immunization concentration of 1:160 that confers protection from infection to 95% of the population.

hemagglutinin/inflammation

Bacillus Calmette-guérin Vaccination to Prevent Infections of the Elderly

Trial of High Dose vs. Standard Dose Influenza Vaccine in Inflammatory Bowel Disease Patients

Cell-mediated Immune Response to Influenza Vaccine

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