A phase 2 vaccine study in healthy adults and adolescents to evaluate the safety and immunogenicity of two oral polio type 2 vaccine candidates

Study title: 
A phase 2 vaccine study in healthy adults and adolescents to evaluate the safety and immunogenicity of two oral polio type 2 vaccine candidates
Long title: 
A Phase 2, double-blind, randomized, placebo-controlled, multicenter study to evaluate the safety and immunogenicity of two novel live attenuated serotype 2 oral poliovirus vaccines candidates, in healthy adults and adolescents previously vaccinated with oral polio vaccine (OPV) or inactivated polio vaccine (IPV), compared with historical controls given Sabin OPV2 or placebo
Date receipt dossier: 
9 mai 2018
EU record number: 
B/BE/18/BVW2
EudraCT number: 
2018-001684-22
Company / Sponsor: 
University of Antwerp
Phase: 
II
Treated organism: 
Humans
Indication category: 
Vaccination
Disease: 
poliovirus disease
Therapeutic approach: 
Prevention
Genetic modification: 
The nOPV2 candidate strains include different combinations of 5 distinct modified regions of the Sabin-2 genome, including changes to the RNA sequence in the 5’ untranslated region of polio genome (5’ UTR), the capsid protein coding region (P1), the non-structural protein 2C, and the polymerase 3D. Of these modifications, only the changes to polymerase 3D result in a change in the amino acid sequence. The rest of the modifications aim to stabilize the genetic sequence against reversion in either the 5’ UTR or capsid regions.
Method of transfer of nucleic acid of interest: 
-
Administered biological material: 
novel type 2 oral polio vaccine (nOPV2)
Route of administration: 
Oral
Locations in Belgium: 
Centre for Evaluation of Vaccination, University of Antwerp; CEVAC - Center for Vaccinology, UGent
Nr of subjects: 
200 healthy OPV-primed adults (age range 18 to 50 years) and 132 healthy IPV- only-primed adults and adolescents (15 to 50 years)
Foreseen duration: 
Recruitment of the first participants is expected to start in the second half of 2018 (Q3/Q4). Completion will depend on availability of participants fulfilling all selection criteria and could take up 3 to 5 months.
Type of procedure: 
Contained use and Deliberate release
Current status: 
Authorized

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