100
Participants
Start Date
June 17, 2019
Primary Completion Date
July 1, 2026
Study Completion Date
October 1, 2026
Bacille Calmette-Guerin vaccine
"One dose (0.1 mL) contains 50 μg of the semi-dry mass of BCG bacilli, i.e. from 150,000 to 600,000 of live BCG bacilli (Bacillus Calmette-Guerin), the Brazilian Moreau substrain.~One ampoule or vial with the powder contains: 0.5 mg (from 1.5 mln to 6 mln) of live BCG bacilli (Bacillus Calmette-Guerin), the Brazilian Moreau substrain.~Powder: monosodium glutamate. Solvent: isotonic solution of sodium chloride."
Placebo
isotonic solution of sodium chloride (2mL vials).
RECRUITING
"Center for Experimental Neurological Therapies (CENTERS), S. Andrea Hospital, Faculty of Medicine and Psychology, Sapienza University of Rome", Rome
S. Andrea Hospital
OTHER