Date receipt dossier
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.