Phase 1 clinical trial evaluation of two genetically modified vaccines against poliovirus

Study title: 
Phase 1 clinical trial evaluation of two genetically modified vaccines against poliovirus
Date receipt dossier: 
7 apr 2017
EudraCT number: 
2015-003325-33
Company / Sponsor: 
UZ Antwerpen
Phase: 
I
Treated organism: 
Humans
Indication category: 
Vaccination
Disease: 
Poliomyelite
Therapeutic approach: 
Prevention
Genetic modification: 
Genetic modifications of the nOPV2 vaccine candidates aimed at stabilizing the genetic sequence against reversion compared to the Sabin-2 strain, nOPV2 candidate 1 (S2/cre5/S15domV/rec1/hifi3), nOPV2 candidate 2 (S2/S15domV/CpG40)
Method of transfer of nucleic acid of interest: 
Not applicable, RNA modification
Administered biological material: 
Geneticaly modified OPV2 strains
Route of administration: 
Oral
Locations in Belgium: 
UZ Antwerpen
Nr of subjects: 
30 participants
Foreseen duration: 
May 2017- October 2017
Type of procedure: 
Contained use only
Current status: 
Authorized
Notes: 
The study consisted of two sequential cohorts with a full containment phase of 28 days with post-discharge precautions during a maximum of 62 additional days for the second cohort.