Vaccination for infection prevention MedDRA version: 19.1 Level: LLT Classification code 10036897 Term: Prophylactic vaccination System Organ Class: 100000004865 MedDRA version: 19.1 Level: LLT Classification code 10046859 Term: Vaccination System Organ Class: 100000004865
Conditions
Interventions
Trade Name: BCG Vaccine
Product Name: Bacillus Calmette Guerin
Pharmaceutical Form: Injection
Pharmaceutical form of the placebo: Injection
Route of administration of the placebo: Intradermal use
Sponsors
Hellenic Institute for the Study of Sepsis
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female • Age more than or equal to 65 years based on the precise date of birth • Discharge from hospital after hospitalization for a medical cause. All medical causes make patients eligible for enrolment with the only exception of medical causes mentioned in the exclusion criteria 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 200
Exclusion criteria
Exclusion criteria: • Failure to obtain written informed consent • Solid organ malignancy or lymphoma diagnosed the last five years • Treatment with oral or intravenous steroids defined as daily doses of 10mg prednisone or equivalent for longer than 3 months • Severely immunocompromised patients. This exclusion category comprises: a) patients with known infection by the human immunodeficiency virus (HIV-1); b) neutropenic patients with less than 500 neutrophils/mm3; c) patients with solid organ transplantation; d) patients with bone marrow transplantation; e) patients under chemotherapy; f) patients with primary immunodeficiency; g) severe lymphopenia with less than 400 lymphocytes/mm3; h) treatment with any anti-cytokine therapies. • Positive Interferon-gamma Release Assay (IGRA)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the study is to demonstrate in a double-blind, placebo-controlled approach if vaccination of elderly patients with BCG vaccine may modulate their disease susceptibility for bacterial diseases. This will be validated using both clinical and immunological criteria. ;Secondary Objective: Not applicable;Primary end point(s): The primary study endpoint will be the time interval to the first infection post hospital discharge between the two groups of treatment. ;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Rate of hospitalizations until month 12 • Time to first infection or sepsis episode • Total number of infections • Time to first hospitalization • Number of antibiotic administrations • One-year mortality • Cytokine stimulation after 3 months • Epigenetic changes after 3 months • Effect of BCG vaccination on cost of treatment for infections after 12 months ;Timepoint(s) of evaluation of this end point: 12 months | — |
Countries
Greece
Contacts
Public ContactPresident of the Board
Hellenic Institute for the Study of Sepsis
Outcome results
None listed