250
Participants
Start Date
October 22, 2018
Primary Completion Date
January 31, 2019
Study Completion Date
May 8, 2019
Novel OPV2 candidate 1
"Live-attenuated serotype-2 poliovirus derived from a modified Sabin type-2 infectious cDNA clone and propagated in Vero cells; candidate 1 (S2/cre5/S15domV/rec1/hifi3).~Modifications included the following:~* Changes to the viral nucleotide sequence in part of the 5'-untranslated region to improve the genetic stability of this major attenuating determinant of Sabin type-2 to avoid reversion by single nucleotide changes.~* Two modifications in the polymerase 3D to further improve stability of the attenuation and reduce frequency of recombination events~* Relocation of a key replication element from the 2C coding region to the 5'-untranslated region, to inhibit recombination."
Novel OPV2 candidate 2
"Live-attenuated serotype-2 poliovirus derived from a modified Sabin type-2 infectious cDNA clone and propagated in Vero cells; candidate 2 (S2/S15domV/CpG40).~Modifications included the following:~* Changes to the viral nucleotide sequence in part of the 5'-untranslated region to improve the genetic stability of this major attenuating determinant of Sabin type-2 to avoid reversion by single nucleotide changes.~* silent non-coding modifications engineered within the capsid (VP1-4) designed to reduce replicative fitness and, potentially, to improve stability of the attenuated phenotype while also reducing transmission."
Placebo
sugar syrup, propylene glycol (Sirupus simplex, Propylenglycolum, European Pharmacopoeia)
Centre for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute, University of Antwerp, Wilrijk
CEVAC, Center for Vaccinology, Ghent University Hospital, Ghent
Collaborators (1)
Bill and Melinda Gates Foundation
OTHER
Centers for Disease Control and Prevention
FED
PATH
OTHER
Celerion
INDUSTRY
Pierre Van Damme
OTHER